Pfizer
Nervous system symptom reports
Male, 40 - 59 years
| Age | Reported | Symptoms | Notes |
|---|---|---|---|
| 40 | 2021-01-03 | hot flush, tingling, feeling hot |
Pt entered observation around 1950. Around 2010, stated that "his body felt warm and tingling, thro...
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Pt entered observation around 1950. Around 2010, stated that "his body felt warm and tingling, throat was sore, and he had a flush feeling". Denies SOB or chest pain when asked. Continued to remain in observation. Stated that he felt somewhat better around 2015. Still had the same symptoms but they were letting up some. Around 2025, he stated that he felt better and the symptoms had stopped. Pt left observation @ 2027
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| 40 | 2021-01-04 | feeling cold, tingling, cold extremities, sensory loss |
COVID vaccine Tuesday. Some soreness at the site that resolved over 2 days. Over the past 24 hours...
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COVID vaccine Tuesday. Some soreness at the site that resolved over 2 days. Over the past 24 hours, developed some mild parasthesias [nonspecific]. Aren't painful, but tingling is annoying, contributed to restless night last night. Response 12/26: Acetaminophen, Start B-complex with Fe, report if not already done Chart 12/26: Reported. A bit better this am but will start vitamins Chart 12/29 [excerpt] Still having same symptoms of parasthesias. Started multivitamin as well as acetaminophen. I've noticed it affects only the right side of my body, and that it's purely sensory, no motor changes. Still mild, but not been sleeping well Responded, scheduled appt. Vaccinated in L deltoid. Describes R side of body feels 'Cold' [dysesthesia] on R side of body and extremities. No weakness, no change in ROM. No joint swelling. No rash. Sensation feels less on R but still sense of touch. Thinks this is about the same- notices more when lies down in bed than in daytime. Symptoms persist 1/5/2021: Referred to Neurology at his request
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| 40 | 2021-01-06 | weakness | Drowsy, injection site pain, chills, aches/pains, weakness |
| 40 | 2021-01-06 | feeling cold |
lost his sense of smell/cannot smell anything; Sore throat; sweating a lot; Fever; chills; body felt...
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lost his sense of smell/cannot smell anything; Sore throat; sweating a lot; Fever; chills; body felt cold; This is a spontaneous report from a contactable consumer (patient) reported that a 40-year-old male patient receives first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch Number: EH9899 and Expiration Date: 31Mar2021) via an unspecified route of administration on 21Dec2020 14:30 at single dose in left arm for Precaution (covid-19 immunization). NDC number of Pfizer COVID Vaccine: 59267-1000-2. The patient's medical history and concomitant medications was reported as none. The patient works in a hospital and got the first shot. Before he got the vaccine, he did not have any symptoms and felt great. They told him he may feel some symptoms for a couple of days. Now, he was getting symptoms of COVID 2 nights ago (around 20:00 28Dec2020) such as fever, chills, body felt cold, fever. Last night (30Dec2020) when he slept, he sweated a lot. Maybe it is one of the reasons. He did not have a fever, but he sweated a lot. He felt like his shirt was wet in the morning. He also had sore throat and lost his sense of smell on 06:00 31Dec2020. It is weird. He never had that before. He doesn't know what the do. If it was normal or it was symptoms of COVID. Second one will be on 12Jan2020. Should he get tested for COVID. Wanted to know if he should get the second dose. The outcome of events, fever, chill, felt cold, sweating a lot was recovering. The outcome of sore throat and cannot smell anything was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 40 | 2021-01-06 | tingling |
Employee returned to vaccination area at 13:45, reported mild intermittent tingling in hands and fee...
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Employee returned to vaccination area at 13:45, reported mild intermittent tingling in hands and feet bilat; primarily feet and primarily when he sat down. Also reported mild brief blotchiness to bilat lower forearms. Narrative: Mildly anxious, mild reactions to which he was unsure if he should return to vaccination site or not. Denied dizziness, light-headedness, palpitations. Reported mild feeling of a 'rush' "kind of feeling, like, stimulated". VS: at 13:46: BP 14977. O2 99%, P 79, T 36.3. Reported he had been continuing doing his duties without difficulty but didn't know if he should be concerned. Noted blotchiness on forearms under different lighting when he went to restroom. Blotchiness mild to moderate and mostly resolved before he left. VS at 14:02: BP 136/69, O2 99%, P 80, T 36.7. Reported tingling mostly resolved if he stretches his legs out some. Reported anxiety over "the whole thing. It's just weird and I've been excited about the vaccine". Reviewed S/S to be aware of, when to seek medical attention and that he was feeling completely stable and comfortable before he left. Positively reactive to increased information and seeing improvement in blotchiness. Left at 14:08.
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| 40 | 2021-01-10 | difficulty speaking |
AT APPROXIMATELY 1000, PATIENT BEGAN COMPLAINING OF FEELING "VERY NAUSEOUS" AND NEEDED A BIN. PATIE...
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AT APPROXIMATELY 1000, PATIENT BEGAN COMPLAINING OF FEELING "VERY NAUSEOUS" AND NEEDED A BIN. PATIENT WAS BROUGHT BACK INTO THE IMMUNIZATIONS CLINIC FROM THE WAITING ROOM. ONCE SEATED, PATIENT THEN BEGAN FEELING "HOARSE AND TROUBLE BREATHING", WHICH THEN EPI-PEN WAS GIVEN AT 1004. VITALS AFTER EPI PEN BP 133/77 O2 99% HEARTRATE 103. CODE WAS CALLED SIMULTANEOUSLY. PATIENT WAS THEN BROUGHT TO EMERGENCY DEPARTMENT VIA WHEELCHAIR WITHIN THE HOSPITAL BY CODE TEAM.
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| 40 | 2021-01-10 | pain in extremity | Fatigue Sore throat, Arm pain-resolved 24hr |
| 40 | 2021-01-11 | migraine | Migraine 26 hrs after shot, Nausea 20 hrs after shot |
| 40 | 2021-01-11 | pain in extremity |
Bad chills and muscle aches, intermittent for 30 hours, controllable with Tylenol and ibuprofen arou...
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Bad chills and muscle aches, intermittent for 30 hours, controllable with Tylenol and ibuprofen around the clock. No fevers. Mild localized arm pain. Mild cough.
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| 40 | 2021-01-12 | flushing, tingling | Itchiness, flushing, tingling, redness |
| 40 | 2021-01-12 | numbness |
This patient experience left sided numbness (felt like left arm and left leg was heavy); This patien...
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This patient experience left sided numbness (felt like left arm and left leg was heavy); This patient experience left sided numbness (felt like left arm and left leg was heavy); This is a spontaneous report from a contactable pharmacist. A 40-year-old male patient received first dose of bnt162b2 (BNT162B2 reported as COVID-19 vaccine; lot number: EL1284; expiration date: unknown), intramuscular left arm on 07Jan2021 11:00 at a single dose for covid-19 vaccination. The patient has no medical history. The patient has no allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not have any other medications the patient received within 2 weeks of vaccination. The patient received the most recent COVID-19 vaccine in a nursing home/senior living facility. This patient experience left sided numbness (felt like left arm and left leg was heavy) on 07Jan2021 11:00 AM. The event was reported as non-serious. The adverse event result in emergency room/department or urgent care visit. No treatment was received for the adverse event. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. The outcome of the events was unknown.
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| 40 | 2021-01-13 | weakness, pain in extremity |
Per reporter: "I received the COVID vaccine on 12/29/2020 (first dose). The first couple days I had ...
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Per reporter: "I received the COVID vaccine on 12/29/2020 (first dose). The first couple days I had a really sore left arm, but didn?t feel any ?side effects? until about Wednesday, 1/6 (about a week later). I remember waking up to a sore left side of my upper body. The left side of my neck, chest, arm, and lymph node (under my left arm) felt weird. It was until about Saturday night, 1/9, that I felt my left under arm lymph node noticeably swollen. I had a bad headache and loss of energy, and overall feeling unwell. No fever or night sweats to report. I was absent from work on 1/11 and 1/12, as a result. 1/13 was my first day back and feel better. The swollen left lymph node is no longer present, but still slightly tired. I did not seek Medical Care for my symptoms.
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| 40 | 2021-01-17 | feeling cold |
Chill, malaise, malaise started that night. Headache/malaise next day. Slight runny nose 2 days lat...
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Chill, malaise, malaise started that night. Headache/malaise next day. Slight runny nose 2 days later. Nasal congestion starting 4 days later. Diagnosed with active COVID-19 infection 6 days later.
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| 40 | 2021-01-17 | pain in extremity |
Patient with PMH of depression and GERD who presented 1/8 with constipation, abdominal discomfort an...
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Patient with PMH of depression and GERD who presented 1/8 with constipation, abdominal discomfort and worsening dyspnea. Symptoms began around 12/29. COVID vaccine 12/19. Previously quite active, marathon runner, gained some weight over last couple years but was still in good enough shape to complete 10K in New Orleans in early February. In late February, had a flu-like illness, as did one of his friends from church. 2020 was hard on him - weight gain, decreased activity, stress, overall deconditioning. No issues apart from sore arm after COVID vaccine 12/19 but then starting getting abdominal fullness/discomfort around 12/29, which steadily worsened, also develop worsening dyspnea on slight exertion. No known sick contacts.. Work-up notable for pericardial effusion, pleural effusions. Echo with severe diffuse LV hypokinesis, concern raised for myocarditis. COVID PCR negative, serology negative. RVP negative. . Concern raised that COVID vaccine may have played a role in myocarditis. He was found to have the following conditions Acute heart failure with reduced EF NYHA FC II, non-ischemic cardiomyopathy. Myocarditis appears subacute per MRI hypertension obesity small pericardial effusion- asysmptomatic no pericarditis suspected obstructive sleep apnea. .Started on the following medications. Continue Carvedilol 12.5mg BID, Farxiga 5mg daily, Digoxin 0.125mg daily, Entresto 97-103mg BID, and Spironolactone 25mg daily. Per MD note. While it remains uncertain, team is doubtful COVID vaccine played a role in his cardiac issues. Given the MRI findings are not acute, more likely that the cardiac insult occurred weeks to months ago - potentially in the setting of the February 2020 illness. Perhaps his "deconditioning" in 2020 was related to worsening cardiac function. Nevertheless, will hold on 2nd COVID vaccine dose given absence of a clear explanation for his myocarditis. conversation with team will continue to determine if candidate for second covid vaccine. If consensus is that myocarditis pre-dated vaccine, might be able to proceed with dose 2 of vaccine.
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| 40 | 2021-01-17 | tingling | to ed with chest pain, diaphoresis and arms tingling |
| 40 | 2021-01-18 | tingling, burning sensation |
I have had nueropathy induced by antibiotics in the past. I have been in remission for 6 weeks after...
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I have had nueropathy induced by antibiotics in the past. I have been in remission for 6 weeks after a one week reaction to St Johns Wort, but before that was in remission for a year or two. 25 hours after getting the covid vaccine last week, I started getting burning nerves, tingling, and pins and needles, which has only gotten worse in the last 3 days. There were no symptoms of this right before the vaccine.
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| 40 | 2021-01-19 | pain in extremity, numbness |
About 3 minutes after the shot I begin to taste it in my mouth and seconds after that my pinky and r...
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About 3 minutes after the shot I begin to taste it in my mouth and seconds after that my pinky and ring finger on my left hand went numb and has been like that ever since. At one point my whole hand tingled. I even had pain in my bicep on the same side
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| 40 | 2021-01-20 | weakness |
Drowsy; Weak; Pain in the knees/pain in his joints/joint pain from his Legs, Arms, and fingers; Both...
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Drowsy; Weak; Pain in the knees/pain in his joints/joint pain from his Legs, Arms, and fingers; Both of his eyes feel tired; could not lift arm; bruised under the arm; back pain; neck pain; could not turn neck; headache; Pain with bending head down; This is a spontaneous report from a contactable consumer. A 41-year-old male consumer received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in left arm on 11Jan2021 at 07:45 at single dose for COVID-19 immunisation at the age of 40-year-old. Medical history included HIV infection, root canal in Dec2020, COVID-19 in Jun2020 or Jul2020. Concomitant medications were unknown. Vaccination history included first dose of BNT162B2 on 21Dec2020 for COVID-19 immunisation (could not lift arm, bruised under the arm, back pain with his neck he could not turn it, he could not be on his left side where he got the shot on left arm, headache). The patient experienced drowsy, weakness, knee pain, joint pain, could not lift arm, bruised under the arm, back pain, neck pain and could not turn neck, Headache, pain with bending head down, both eyes feel tired. In Jun2020/ Jul2020, the patient resulted positive to SARS-CoV-2 test; then, the patient had 3 negative SARS-CoV-2 test; weight: lost. The outcome of the events was unknown. Information on the lot/batch number has been requested.
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| 40 | 2021-01-21 | numbness, tingling |
Reports he has been diagnosed with Guillain Barre syndrome. Symptoms started with 2 fingers tingling...
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Reports he has been diagnosed with Guillain Barre syndrome. Symptoms started with 2 fingers tingling 1/11/21. Progressively increasing in severity. Now has numb fingers and toes. Initiating IV therapy 1/22/21.
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| 40 | 2021-01-22 | tingling, hypersensitivity of all senses, burning sensation |
Progressive Burning of fingers and toes followed by worsening tingling and hyperasthesia . Notable S...
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Progressive Burning of fingers and toes followed by worsening tingling and hyperasthesia . Notable Symptoms started 48 hrs post second dose of covid 19 vaccination , worsened over the next 7-10 days. Basic metabolic lab work done. Seen by neurology on 1/21/2021. Started on IV therapy on 1/22/2021. Ongoing transfusion treatment in an outpatient setting
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| 40 | 2021-01-25 | facial pain, facial paralysis |
Inmate seen in health services with complaint of left ear pain extending into left cheek and around...
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Inmate seen in health services with complaint of left ear pain extending into left cheek and around his mouth. He has some drooping of the left side of his mouth and he is not able to blink or close his left eye. He noticed symptoms on 1-23-2021, the Saturday after getting the COVID 19 vaccine on 1-21-2021 (Thursday). Had some trouble swallowing liquids without having them dribble out the left side of his mouth and he says that he is not able to chew on the left side without biting his tongue. Says that his left ear is causing him a great deal of pain.
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| 40 | 2021-01-26 | pain in extremity |
STARTED 1/27/2021 5AM WITH GENERAL MALAISE, BODYACHE, NAUSEA, EYE REDNESS, PHOTOPHOBIA, FEVER, LEFT...
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STARTED 1/27/2021 5AM WITH GENERAL MALAISE, BODYACHE, NAUSEA, EYE REDNESS, PHOTOPHOBIA, FEVER, LEFT ARM AND AXILLARY PAIN ,
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| 40 | 2021-01-27 | pain in extremity |
Fever; chills; nausea; vomiting; diarrhea; sore arm; This is a spontaneous report from a contactable...
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Fever; chills; nausea; vomiting; diarrhea; sore arm; This is a spontaneous report from a contactable consumer (patient). A 40-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), via an unspecified route of administration at right arm on 15Jan2021 16:00 at single dose for COVID-19 immunization. Medical history included COVID prior to vaccination. The patient has no known allergies. The patient's concomitant medications were not reported. The patient experienced fever, chills, nausea, vomiting, diarrhea, and sore arm on 16Jan2021. No treatment was received for the events. The patient was not tested for COVID post vaccination. The patient was recovering from the events.
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| 40 | 2021-01-28 | speech disorder |
Received COVID vaccine and within 2 minutes developed tongue "thickness", throat tingling, overactiv...
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Received COVID vaccine and within 2 minutes developed tongue "thickness", throat tingling, overactive salivary glands, light-headed. States speech was affected due to tongue swelling. No respiratory distress. Took Benadryl 25mg approx. 45 minutes after symptom onset. Symptoms improved 1 hour after taking Benadryl dose. Does NOT plan to receive 2nd dose due to immediate allergic reaction.
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| 40 | 2021-01-31 | feeling cold, feeling hot |
30th January 2021-Am-rash-size od baseball, chills, HA-is this his from his tooth or COVID-19-he won...
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30th January 2021-Am-rash-size od baseball, chills, HA-is this his from his tooth or COVID-19-he wonders, PM-freezing & hot body. 31st January 2021-more of the same-chills, HA, hot body- freezing, rash still present on his left deltoid area 1 February 2021-less chills, moving slowly, Left deltoid less hot, not as freezing Taking Tylenol, motrin. Reminded IF he gets worse-go to the ER. Reminded him-does he need to contact his PCM-do so.
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| 40 | 2021-01-31 | tingling |
Headache, nerves in skin were raw and inflamed, agitated by touch. Fever, chills. Nausea. Chest co...
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Headache, nerves in skin were raw and inflamed, agitated by touch. Fever, chills. Nausea. Chest congestion, cough. Loss of taste and smell (this began on 01/31). All side effects symptoms are still present on 02/01.
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| 40 | 2021-02-01 | tremor |
About 2 to 3 minutes after receiving the injection I felt light headed and passed out. My wife said ...
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About 2 to 3 minutes after receiving the injection I felt light headed and passed out. My wife said my eyes were open but glazed over. I also started shaking. When I woke up I was confused and felt nauseated. A few minutes after I woke up the EMTs ran my vitals. My heart rate was in the 40s and my blood pressure was in the 90s. I have never had a reaction like this to any other shot/vaccines.
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| 40 | 2021-02-04 | cold sweat |
First day - Cold sweats, Fever, Chills, Headache, Nausea, Diarrhea, Body aches, Extreme back pain. S...
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First day - Cold sweats, Fever, Chills, Headache, Nausea, Diarrhea, Body aches, Extreme back pain. Second day - Back pain, Nausea, No fever
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| 40 | 2021-02-04 | tingling, numbness |
Guillain Barre syndrome/Symptoms started with 2 fingers tingling; This is a spontaneous report from ...
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Guillain Barre syndrome/Symptoms started with 2 fingers tingling; This is a spontaneous report from a contactable nurse reporting for a patient. A 40-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK4176), via intramuscular on 09Jan2021 at single dose in left arm for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1685), via intramuscular on 22Dec2020 at single dose in left arm at the age of 39-year-old for COVID-19 immunization. Reported he was diagnosed with Guillain Barre syndrome. Symptoms started with 2 fingers tingling on 11Jan2021. Progressively increasing in severity. Now had numb fingers and toes. Initiating IV therapy on 22Jan2021. The adverse event result in Doctor or other healthcare professional office/clinic visit. The outcome of the event was unknown.; Sender's Comments: As an individual case report there is not enough evidence to establish a causal relationship with the suspect vaccine. Currently there is no clear biological plausibility between the vaccine use and the even onset. More information such as complete medical history and concomitant medications are needed for fully medical assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 40 | 2021-02-05 | flushing |
40 y.o. male with PMHx including asthma and HLD presenting to the ED today with c/f allergic reactio...
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40 y.o. male with PMHx including asthma and HLD presenting to the ED today with c/f allergic reaction. Pt is coming in after about 35 minutes ago he had some extreme flushing he describes it as "feeling like he put his head in an oven and some skin itchiness on his arms. He notes he started taking niacin today. He also got his second dose of his Covid vaccine last night. He has no throat swelling or difficult breathing. He has not had any nausea or vomiting. He denies any recent fevers or chills. He did switch his asthma medications to Trelegy last week. He otherwise has no other allergies. The patient had just started taking Niacin which is more likely the etiology of the case in question and symptoms rather than the vaccine-pfizer. Most likely this was related to the niacin and not the pfizer vaccine.
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| 40 | 2021-02-07 | unresponsive to stimuli |
Patient presents to ED on 1/14/2021 with respiratory arrest and started around 1300. Per EMS, report...
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Patient presents to ED on 1/14/2021 with respiratory arrest and started around 1300. Per EMS, reportedly told fiance that he had taken some sleeping pills and was going to go to sleep. EMS was called after the patient was found unresponsive about 15 minutes later. Family attempted to do CPR. Upon EMS arrival to the patient's home, patient had a pulse, was in respiratory distress with agonal breathing. They also reported emesis in the airway. EMS performed nasal intubation and administered 10 mg IV Narcan en route. Upon arrival to the hospital, patient was moving arms more and gritting teeth. Patient had movements of decerebrate posturing of arms intermitting with a relaxed posture. GCS was 4 on arrival. Patient is currently still in ICU and has been extubated.
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| 40 | 2021-02-08 | burning sensation, hypersensitivity of all senses, feeling hot, pain in extremity |
Saturday evening experienced headache and nausea. Both symptoms continued and left upper arm began t...
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Saturday evening experienced headache and nausea. Both symptoms continued and left upper arm began to feel hot and very painful and sore to touch which started later in the evening. Sunday all day nausea, headache and sore arm continued with chills and whole body feeling hot. I may have had a fever but did not confirm with thermometer. Treatment included increase hydration with water and rest. I felt like my normal self on Monday morning.
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| 40 | 2021-02-09 | pain in extremity, night sweats |
Within 5 minutes of getting the shot on 2/6 I felt pain in the upper arm that moved down to forearm ...
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Within 5 minutes of getting the shot on 2/6 I felt pain in the upper arm that moved down to forearm into left pinky. At approximately 3 pm arm started to hurt at the injection site. Iced for the next 36 hours until the swelling went down. On 2/7/21 at 10 pm started feeling like sickness was starting. On 2/8/21 was lethargic with body aches, headache, dry cough, and temperature up to 101.5 degrees F. Took 325 mg of Tylenol every 6 hrs. 2/9/21 up dose of Tylenol to 500 mg every 6 hrs as fever increased. Experienced night sweating and severe joint pain in hips, lower back, and along the upper spine. Fever broke at approximately 7 pm 2/9/21. Joint pain continues through 2/10/21
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| 40 | 2021-02-09 | pain in extremity |
All body temperatures taken with the same infra-red thermometer at same site, center of forehead. Re...
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All body temperatures taken with the same infra-red thermometer at same site, center of forehead. Regularly Consume approximately 3/4 Gallon of water through the course of a day. 2/08/2021 3:30pm - Injection 4:30pm - Typical sore arm 2/9/2021 8:00am - Slept through the night, very drowsy, some body aches, temp 99.8 9:00am - Body aches growing in intensity, temp 101.1 12:00am - Chills, severe body aches, temp 102.6, went to lay down, fell asleep 6:00pm-11:00pm - Severe body aches continue, temp 103.9 - 104.3, monitored every hour. Went to bed 2/10/2021 Fever has come down, 99.7 at this time Body aches in my back continue, along with random chills. Research suggests not consuming any OTC medications such as NSAIDs, and other pain relievers/fever reducers, and allow the vaccination to run its course, as this may impede the body's immune response to the vaccination. No treatment was sought.
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| 40 | 2021-02-10 | pain in extremity |
Patient was observed for 30 minutes. After that time, patient stated to the observer, RN her left ar...
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Patient was observed for 30 minutes. After that time, patient stated to the observer, RN her left arm "hurt all the way down" and "chest felts heavy". Encouraged patient to go to ED, but patient declined. Nurse assessed patient who then felt short of breath. Two RNs took patient, via wheelchair, to ED. Husband was with patient. ED triage took patient back and husband checked in patient.
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| 40 | 2021-02-12 | one side paralysis, sensory loss |
CVA/thrombotic event. R sided weakness and sensory deficit. No preexisting risk factors. Hyperco...
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CVA/thrombotic event. R sided weakness and sensory deficit. No preexisting risk factors. Hypercoaguable work up negative. Managed conservatively. Improvement without resolution of symptoms to date.
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| 40 | 2021-02-12 | tremor |
Violent tremors or chills in the middle of the night for half an hour, followed by a burning electri...
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Violent tremors or chills in the middle of the night for half an hour, followed by a burning electric feeling in my muscles. Not able to sleep afterwards. Woke up and muscles in body are very tight and tense.
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| 40 | 2021-02-16 | pain in extremity |
Symptoms began at 6pm. Fever, headache, runny nose, chills, pain in left arm, nausea. Took 1 Advil a...
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Symptoms began at 6pm. Fever, headache, runny nose, chills, pain in left arm, nausea. Took 1 Advil at 7pm. Advil is cutting the pain.
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| 40 | 2021-02-20 | breast pain |
I had practically no side effects from shot #1....shot #2 was different. Starting about 6-8hrs after...
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I had practically no side effects from shot #1....shot #2 was different. Starting about 6-8hrs after injection I started to feel lethargic. By 10hrs, I started with varying chills/sweats that lasted all night, injection site soreness, and soreness in left breast area. The next day I was extremely exhausted and had trouble staying awake. Muscle aches in both shoulders and neck. Also had varying fever from 100 up to 104.1 throughout the day. At 36hrs after injection. I took 2 Advil to help with the muscle aches...nothing taken to this point. 48hrs After injection some energy returned, but still lethargic throughout the day, and occasion fever between 100-101. During shower, I noticed swelling under my left armpit, not present on the right side. At 60hrs after injection, fever gone, energy returned...lingering soreness of left shoulder and breast area and swelling under left armpit remains. At no point did I have any breathing or lung issues...but otherwise it felt like I had a bad flu (minus the coughing/wheezing) for 2 days.
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| 40 | 2021-02-22 | pain in extremity |
My arms felt sore soon after the injection I felt a little tired around 9:00 a.m on the 23rd. and th...
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My arms felt sore soon after the injection I felt a little tired around 9:00 a.m on the 23rd. and then extreme fatigue chills and body aches around 7:00 p.m.
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| 40 | 2021-02-23 | numbness, hot flush |
Felt fine during the 15min waiting period, but once I got back to work started getting hot flashes b...
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Felt fine during the 15min waiting period, but once I got back to work started getting hot flashes but no temp and face went numb. still had smell and taste just felt like I went to the dental where they numb your face. Went to the ER because Nurse Advice Line said to. ER gave me Benadryl and that is all. Had symptoms for about two weeks.
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| 40 | 2021-02-23 | pain in extremity |
very sore arm, could not lift it, fatigue hit almost 24 hours exactly after injection, rash the foll...
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very sore arm, could not lift it, fatigue hit almost 24 hours exactly after injection, rash the following day over chest and neck
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| 40 | 2021-02-25 | numbness | Systemic: Numbness (specify: facial area, extremities)-Mild |
| 40 | 2021-02-27 | numbness |
Heart attack. Chest pain and numbness in both arms and back. The pain lasted from 3:00AM until 5:00A...
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Heart attack. Chest pain and numbness in both arms and back. The pain lasted from 3:00AM until 5:00AM at which time I as in the ER. Troponin levels were at 6.0 and I had a small abnormal finding on my EKG. The Cardiovascular physician on call said it could be something and they would do a cardiac cath to determine where a blockage may be. The angiogram cam back with no blockages. troponin levels reached a 10 by the end of the first day. The Echo the next day showed no issues in structure. The Cardiac MRI showed fluid and 4% of my heart had myocarditis from the issue. Troponin levels reduced to 7, then 6 by the end of the second day. On the third day I went home with new meds, an order for a follow up and cardiac rehab.
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| 40 | 2021-03-02 | pain in extremity |
Pfizer-BioNTech COVID-19 Vaccine EUA: Patient presents to urgent care one day after vaccination with...
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Pfizer-BioNTech COVID-19 Vaccine EUA: Patient presents to urgent care one day after vaccination with fatigue, chest tightness, back pain, myalgias, headaches, right arm soreness, and decreased concentration. Patient states had COVID-19 illness in October 2020 and current symptoms are similar. Patient denies facial/throat swelling, palpitations, rash, or lesions and reports some symptom improvement with acetaminophen. Vitals within normal ranges except blood pressure 141/84 attributed to white coat syndrome. Advised to continue acetaminophen and discharged to home stable.
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| 40 | 2021-03-02 | pain in extremity | Sore upper arm. Red ring around injection site. Tender, itchy, raised skin around injection site. |
| 40 | 2021-03-03 | numbness |
After 5 min of receiving the vaccine, client became diaphoretic, pallor observed and reported numbne...
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After 5 min of receiving the vaccine, client became diaphoretic, pallor observed and reported numbness to bilateral hands. BP taken using manual cuff at 14:26 hrs and recorded 68/42, HR 51 bpm with O2 saturation of 98 % on RA. LCTA, S1 and S2 audible to L apex 4th intercostal space. Water was provided to the client. EMS was notified; EKG was obtained. Last V/S: BP of 103/68, HR of 79 bpm and RR of 18. Client declined EMS care and declined to go to the hospital. Client was discharged home with wife; ambulated to car with steady gait. Alert/ Oriented x 3.
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| 40 | 2021-03-03 | pain in extremity | Pfizer-bioNTech Covid-19 Vaccine Sore arm Tired |
| 40 | 2021-03-04 | feeling hot |
I got really hot and started sweating a few minutes after my injection and I have been getting hot a...
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I got really hot and started sweating a few minutes after my injection and I have been getting hot and sweaty for no reason since. I want to know if it's safe to get the second injection. And if this will go away.
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| 40 | 2021-03-06 | electric shock sensation, numbness and pain in extremities, burning sensation |
I have a history of neuropathy that has been dormant most of the last year. I went in with no nuerop...
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I have a history of neuropathy that has been dormant most of the last year. I went in with no nueropathy occuring to get my vaccines. After the 1st Pfizer shot I had neuropathy starting the day after that went away in about a week. After the 2nd about 3 days later it started with itching all over my body (neuropathic itch), and burning mostly in my feet, but random electrical shocks throughout my body 24/7 (while awake). It has not subsided and has actually gotten worse. There are at least a dozen people on the clinic message board saying the same thing happened to them, that the vaccine awakened or made worse their neuropathy exponentially. Here is the link to similar complaints.
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| 40 | 2021-03-08 | pain in extremity, feeling hot, tremor |
Within 8-10 minutes I had a wave of heat start from the back of my head to the front, like the feeli...
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Within 8-10 minutes I had a wave of heat start from the back of my head to the front, like the feeling you get right before you go under from anesthesia. My heart began to race and I was lightheaded. I reported the reaction and was given an oximeter to check oxygen and heart rate. Heart rate was 140, oxygen 99. BP was also checked and was normal. Was given water and sat for another 10 minutes. Felt better and heart rate was under 100 until another wave of lightheadedness came over me and heart rate spiked again to over 120. It came down again. A few minutes later lightheadedness came back, shaking started, and heart rate spiked again. It lasted about 10 minutes. After 55 minutes of staying at facility I was able to leave. However, did have one more brief episode of lightheadedness and heart rate spiking. Sore arm and extreme ringing in one ear were only side effect the following day.
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| 40 | 2021-03-09 | weakness | Following 1 week of the normal symptoms, 2 weeks of weakness, muscle pain and mild depression. |
| 40 | 2021-03-09 | pain in extremity | Muscle aches, chills, 100.4 temperature, headache, sore arm. All lasted approximately 12 hours |
| 40 | 2021-03-10 | numbness |
Jaw pain/tightness, tongue numbness (sides) within first 5 min after injection; mild and lasted for...
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Jaw pain/tightness, tongue numbness (sides) within first 5 min after injection; mild and lasted for 1-2 hours.
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| 40 | 2021-03-11 | numbness |
patient waited his 15 minutes for observation. he walked out of the vaccination clinic about 12:23 ...
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patient waited his 15 minutes for observation. he walked out of the vaccination clinic about 12:23 & returned at 12:25 due to feeling like his tongue was numb. he also felt shaky & dizzy
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| 40 | 2021-03-13 | cold sweat, tremor |
Systemic: Dizziness/ Lightheadness-Medium, Systemic: Nausea-Severe, Systemic: Shakiness-Medium, Syst...
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Systemic: Dizziness/ Lightheadness-Medium, Systemic: Nausea-Severe, Systemic: Shakiness-Medium, Systemic: Vomiting-Severe, Additional Details: Patient warned immunizer that he was anxious about receiving vaccine because he is scared of needles. Once he received the vaccine, he became nauseous, sweaty, clammy, dizzy and lightheaded. Pt explained to immunizer that he was switched to night shift and had taken his diabetic meds without food soon before his shift at 5:30pm. An EMT was on scene and she proceeded to call more medics. I checked on the pt and he was vomiting and very pale. Medics checked pt vitals and okayed him for work.
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| 40 | 2021-03-14 | pain in extremity |
When I woke up the morning after I receive the vaccine, it was very painful to move my left arm. The...
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When I woke up the morning after I receive the vaccine, it was very painful to move my left arm. The pain increased if I moved my arm greater than perpendicular to my body. The worst pain though with with my back. I could not stand up straight without a sharp pain starting in my lower back. I was also extremely tired. So I called into work took some Tylenol and went back to bed. By 1 o?clock that afternoon I had felt fine as if nothing had ever happened.
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| 40 | 2021-03-17 | pain in extremity |
Headache, Sedation, Myalgia, Diarrhea, Tachycardia, "I feel like my heart is beating fast" "tired an...
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Headache, Sedation, Myalgia, Diarrhea, Tachycardia, "I feel like my heart is beating fast" "tired and sluggish and slow". Soreness in arm is painful and radiating to neck on left side Narrative: Advised to seek treatment from PCP or Emergency services if symptoms do not improve, worsen, or become severe Other Relevant History:
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| 40 | 2021-03-17 | tremor |
Metallic taste at 6 hours & headache 103 temp at 12 hours with chills and shakes 101 temp at 30 hou...
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Metallic taste at 6 hours & headache 103 temp at 12 hours with chills and shakes 101 temp at 30 hours
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| 40 | 2021-03-19 | weakness |
I had difficulty concentrating and focusing on Wednesday evening, a little over a day after getting ...
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I had difficulty concentrating and focusing on Wednesday evening, a little over a day after getting my first shot. The focusing/concentration issues went away by the next morning when I woke up, however I have been feeling very tired physically since then. I'm yawning all day and have very little energy or interest in doing things I need to be doing. I'm not certain that this is vaccine related, and I'm not super concerned about it yet as I'm on Spring break from school, but I start virtual classes again on Monday and will be concerned if I'm still super tired. If it doesn't go away by next weekend, I will likely resubmit/add on to this report if that is an option. It is not a serious concern yet so I haven't contacted medical professionals yet, but I thought it might be a good idea to at least report that this has been going on to VAERS
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| 40 | 2021-03-20 | muscle twitching |
Began with myokymia (twitch) in left eye which persisted for almost 2 months. Has since spread to r...
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Began with myokymia (twitch) in left eye which persisted for almost 2 months. Has since spread to right eye. Now experiencing blurred vision, double vision, and random muscle twitching in limbs.
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| 40 | 2021-03-20 | tremor, flushing |
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: F...
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Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild
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| 40 | 2021-03-21 | migraine |
Pfizer-BioNTech COVID-19 Vaccine EUA Severe headache & migraines without relief for approximately 72...
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Pfizer-BioNTech COVID-19 Vaccine EUA Severe headache & migraines without relief for approximately 72 hours.
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| 40 | 2021-03-22 | bell's palsy | Bells Palsy |
| 40 | 2021-03-23 | seizure |
Patient had a seizure/convulsion immediately after the vaccination. I did not personally see them ha...
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Patient had a seizure/convulsion immediately after the vaccination. I did not personally see them have the convulsion, but his wife observed this. By the time I had made it to the vehicle he had come to and was fine. Patient was also extremely anxious about receiving the vaccination. We believe his anxiety may have manifested as a seizure/convulsion in some way. No other issues or allergic reactions.
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| 40 | 2021-03-24 | difficulty speaking, pain in extremity |
Starting at 8pm on vaccination day I got loopy and disoriented, and had a hard time speaking intelli...
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Starting at 8pm on vaccination day I got loopy and disoriented, and had a hard time speaking intelligibly. I also had trouble with balance and fine motor skills. Had some personality changes too: became very moody with erratic mood swings. The next day I slept all day because of exhaustion and aches. When I woke up on Wednesday (36hrs later) I was literally screaming in pain because of how bad my arm and shoulder hurt. It hurt to move it, and hurt not to move it. It was excruciating and ibuprofen didn't seem to help at all. Throughout Wednesday I could hardly move my left arm. Getting dressed or washing my hair was very difficult and very painful. I was also still very uncoordinated. My left armpits lymph nodes were so swollen that (1) it filled in my entire armpit so there was no more pit, just a very soft bulge, and (2) the fluid extended all the way to my chest and it looked like I had one breast and one pec.
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| 40 | 2021-03-24 | pain in extremity, tremor, night sweats | chills, body aches, uncontrollable shaking, fever, vomiting, night sweats, pain in left arm |
| 40 | 2021-03-24 | tingling | Fatigue, headache, tingling feeling, mild vertigo and nausea |
| 40 | 2021-03-25 | tingling | the patient felt tingling in the vaccination arm. |
| 40 | 2021-03-26 | unresponsive to stimuli |
Patient came up to counter, stated he felt dizzy. Leaning to the left. Assisted patient into the cha...
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Patient came up to counter, stated he felt dizzy. Leaning to the left. Assisted patient into the chair. Patient proceeded to lose consciousness. Sternal rub ineffective. Weak pulse. Called for FNP (Clinic manager) who brought out Ammonia after assessing the patient. Patient came back around after approximately 60 seconds. Patient did lose control of bladder. Once patient came to, assited to lying down in an exam room for further observation. Patient ambulated out of clinic with father after about 45 minutes.
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| 40 | 2021-03-27 | hot flush | Headache. Hot flashes. Cold flashes. Body aches. Dizzy |
| 40 | 2021-03-28 | weakness |
I was surprised that I am having any side effects due to the fact that I am so very lucky in that de...
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I was surprised that I am having any side effects due to the fact that I am so very lucky in that department, in most cases. The first day, following the shot, I had a bit of soreness at the injection site but it was gone by the following day, Friday, 3/26/21. I had a general feeling of weakness the afternoon and into the night on the day of the shot as well. However, it was about midday or a bit after the following day that I began feeling obvious side effects. These include, primarily, a general feeling of being ill. Headache (but that's not that abnormal & body aches and stiffness similar to a mild version of influenza. It appeared late in the day on Saturday, 3/27/21 and has continued since. (See next page)
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| 40 | 2021-03-28 | discomfort |
Tingle in Left side of tongue. Pressure on Left side of face. Left jaw muscle feels like I have been...
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Tingle in Left side of tongue. Pressure on Left side of face. Left jaw muscle feels like I have been clenching it for a long time.
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| 40 | 2021-03-28 | hypersensitivity of all senses |
1/5 vaccination 1/7 I started feeling like hyperesthesia around R side of chest and abdomen; sensiti...
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1/5 vaccination 1/7 I started feeling like hyperesthesia around R side of chest and abdomen; sensitive to clothing. Persisted for few days. Is this Shingles? Lesion on my back. 1-2 more appeared. I started to take Valtrex for it. Took about 3 weeks to clear up.
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| 40 | 2021-03-29 | tingling, numbness |
awakened with sensation of numbness/tingling in all fingers of both hands on 3/28/2021 after having...
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awakened with sensation of numbness/tingling in all fingers of both hands on 3/28/2021 after having COVID vaccine in left arm on 3/26/2021. Sensation has been continuously present until 3/30/2021 at 5 pm when he is seen by me for a family medicine clinic visit. He had mild tenderness at injection site but otherwise no other effects. He has no weakness in his hands. No paresthesias in his feet. No clumsiness or motor problem of any time. No fever.
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| 40 | 2021-03-30 | weakness, cold extremities |
Systemic: Fainting / Unresponsive-Medium, Systemic: Pale, aware of surroundings-Medium, Systemic: Na...
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Systemic: Fainting / Unresponsive-Medium, Systemic: Pale, aware of surroundings-Medium, Systemic: Nausea-Mild, Systemic: Weakness-Medium, Additional Details: Pt was sitting with wife about 10 minutes after vaccine became unresponsive. Wife got my attention. Had weak pulse, cold to touch, but was responsive to me. Knew his surroundings but said didnt feel 100%. Had NP from minute clinic look at him and called EMS for extra evaluation. Pt was transported to hospital
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| 40 | 2021-03-30 | slurring, unresponsive to stimuli |
Client got lightheaded when changing position from sitting to standing. SN noted client kneeled on a...
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Client got lightheaded when changing position from sitting to standing. SN noted client kneeled on all fours and laid on floor. He become confused and verbally non responsive. His breathing was irregular on our assessment. On arousal patient started to respond after 30-40 seconds. His speech was garbled and delayed and patient was aware that he had fainted. He admits to a history of fainting in the past at work. He was able to walk to observation bay to lay down for approximately an hour. Paramedics were called at the beginning of episode. Bp 129/78, Pulse 78 Resp16, O2 sat 98% temp 32 C temporal He rested in bay about a hour and was transported home via car by wife after refusing transfer to hospital by paramedics
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| 40 | 2021-03-31 | pain in extremity | sore arm lasting through the next day |
| 40 | 2021-04-01 | weakness |
Body ache and difficulty sleeping beginning overnight after shot, increasingly unpleasant body aches...
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Body ache and difficulty sleeping beginning overnight after shot, increasingly unpleasant body aches, weakness, tiredness throughout following day.
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| 40 | 2021-04-03 | pain in extremity |
Initial symptoms first 48 hours first dose; Headache; Joint pain- hips and below (left knee locked u...
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Initial symptoms first 48 hours first dose; Headache; Joint pain- hips and below (left knee locked up and could not bare weight on it). Tiredness; Second dose 48 hours; Fever 101.8; Tiredness; Severe headache; Sore Arm; Approximately 1 month after 2nd dose unknown if related. Sudden hearing loss left ear; Tinnitus; Lightheaded.
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| 40 | 2021-04-04 | pain in extremity, flushing, difficulty speaking |
Spoke with pt 1/11/2021 at 1615 and he was doing well, speaks clearly, does have a mild headache, so...
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Spoke with pt 1/11/2021 at 1615 and he was doing well, speaks clearly, does have a mild headache, sore arm, and dizzy sensation if moves too fast. He was given NFW today and can return in am to fire house/station. ---- EVENT: This employee reports received 2nd shot and about 10 min later he felt nauseated. The nausea progressed to a gagging, which made him vomit, his throat was hoarse constantly trying to clear, had problems exhaling, could speak easily, felt flushed, mild headache, - staff checked vital signs (normal) and given epi. Taken to ER where skin noted bright red all over (torso, face, extremities), but no further n/v/gagging/sob. ER gave IVNS, IV Benadryl, Solu-medrol, Pepcid, and Zofran. Monitored forSpoke with pt 1/11/2021 at 1615 and he was doing well, speaks clearly, does have a mild headache, sore arm, and dizzy sensation if moves too fast. He was given NFW today and can return in am to fire house/station. ---- EVENT: This employee reports received 2nd shot and about 10 min later he felt nauseated. The nausea progressed to a gagging, which made him vomit, his throat was hoarse constantly trying to clear, had problems exhaling, could speak easily, felt flushed, mild headache, - staff checked vital signs (normal) and given epi. Taken to ER where skin noted bright red all over (torso, face, extremities), but no further n/v/gagging/sob. ER gave IVNS, IV Benadryl, Solu-medrol, Pepcid, and Zofran. Monitored for 2 hours and sent home with coworkers with resolution of all symptoms. 1/15/2021 f/u: advised doing well, no further issues. review as of 4/01/2021 shows he received flu vaccine on 1/22/21 w/o issues.
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| 40 | 2021-04-05 | cold sweat |
Patient received first dose Pfizer COVID vaccine and was sitting in observation area. Nurse came to...
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Patient received first dose Pfizer COVID vaccine and was sitting in observation area. Nurse came to get me and patient was found lying on the floor. Patient was cool, clammy, eyes closed but easy to arouse. Patient's friend states he sometimes has a seizure associated with feeling like this. Patient alert and oriented, able to converse, and states he did not fall but sat down in floor prior to lying down. 1119 VS: 98% RA, pulse 69 and regular, b/p 118/72. Ice pack applied to patient along with fanning of patient. Patient states feeling better and brought to sitting position without difficulty. Patient offered juice which he was able to drink without difficulty. Patient assisted into wheelchair and brought back to observation area. 1128 VS: 98% RA, pulse 79 and regular, b/p 122/72. Patient no longer clammy, able to converse and follow directions without difficulty. Patient states he is feeling much better, able to stand without feeling dizzy or lightheaded. Friends present with patient and will drive patient home. Patient transported to car via wheelchair. Able to transfer into car independently.
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| 40 | 2021-04-06 | numbness and pain in extremities |
Onset of all symptoms began on March 17, 2021. Symptom (1) Dry mouth: symptoms are still active; (2)...
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Onset of all symptoms began on March 17, 2021. Symptom (1) Dry mouth: symptoms are still active; (2) Extreme thirst: symptoms are still active; At the minimum, I consume 366 fluid ounces (2.859 gallons) of water per day. (3) Blurry vision: symptoms are still active; (4) Dizzy/lightheadedness: symptoms ongoing; (5) fatigued/tired/muscle fatigue: symptoms ongoing: (6) fever/chills: symptoms no longer present as of April 6, 2021. (7) Extreme weight loss (30 lbs/13.64 kgs); (8) Neuropathy of both left and right hands: symptoms still ongoing; (9) Mental fatigue: symptoms still ongoing.
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| 40 | 2021-04-06 | pain in extremity | Arm pain, general muscle pain, body aches, headache, fatigue, nausea, and lethargy. |
| 40 | 2021-04-06 | tingling |
Thrombocytopenia (109,000); elevated D dimer (3960); fatigue; subjective fever; headache; sweats; in...
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Thrombocytopenia (109,000); elevated D dimer (3960); fatigue; subjective fever; headache; sweats; injection site pain; paresthesias of hand on side of injection; This is a spontaneous report from a contactable physician (reporting for a patient). A 40-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were not reported), intramuscularly, administered in arm left on 15Mar2021 (at the age of 40-years-old) as single dose for COVID-19 immunization. Medical history included hypertension and COVID-19 prior to vaccination; patient had no known allergies. Concomitant medication included lisinopril. Patient had no other vaccine in four weeks and the COVID vaccine was received at a Public Health Clinic/Veterans Administration facility. On 15Mar2021, the patient experienced thrombocytopenia (109,000), elevated D dimer (3960), fatigue, subjective fever, headache, sweats, injection site pain and paresthesias of hand on side of injection. The adverse events resulted in emergency room/department or urgent care. The patient was tested for COVID post-vaccination through a nasal swab and Biofire PCR on 22Mar2021 which were both negative. Therapeutic measure taken as a result of the events included IV hydration. Outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the available information and close temporal association, a possible causal relationship cannot be excluded between the suspect product bnt162b2 and all reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 40 | 2021-04-07 | facial pain |
Sharp headache in that feels like it's "inside his brain." Also had unilateral ear and head/face pai...
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Sharp headache in that feels like it's "inside his brain." Also had unilateral ear and head/face pain on the left side the evening of the vaccine. H/A is recurrent and has not changed. Has treated with ibuprofen , Sudafed, and Nasacort. Was seen by PCM on 4/7 and diagnosed with Neuritis and given Prednisone 30mg taper.
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| 40 | 2021-04-07 | numbness, tingling |
Whole body Numbness and tingling, loss of feeling of lower right arm and lower right leg. Loss of co...
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Whole body Numbness and tingling, loss of feeling of lower right arm and lower right leg. Loss of control of lower right arm. Extreme fatigue unable to get up and move at times. Very light headed and on the verge of blacking out.. possibly Loss of consciousness. Extreme tightness in chest. Increase work of breathing. Confusion. Unable to keep eyes open and maintain alertness. Extremely tired Symptoms have gotten a little better throughout the day of april 8th with lots of rest and very little physical activity. I still have slight tightness in chest. Increase work of breathing. Still have tingling throughout body and am lightheaded. When doing any physical activity I become fatigued and lightheaded very fast and must stop after 5-10 minutes. Tongue is still tingling and metallic taste in moutg
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| 40 | 2021-04-08 | flushing |
light headed and heat rush from head down, history of feeling dizzy with needles. no breakfast/ lunc...
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light headed and heat rush from head down, history of feeling dizzy with needles. no breakfast/ lunch today. refused transport.
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| 40 | 2021-04-08 | tingling, cold extremities |
My feet are cold as well feeling of left foot tingling when sitting or laying down.; Chest pains; Li...
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My feet are cold as well feeling of left foot tingling when sitting or laying down.; Chest pains; Lightheadedness; My feet are cold as well feeling of left foot tingling when sitting or laying down.; This is a spontaneous report from a contactable consumer (patient). A 40-year-old male patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EM9810, Expiration date was not reported), via an unspecified route of administration, in left arm on 19Feb2021 12:45 as single dose for covid-19 immunisation. Medical history included gout. Concomitant medication included allopurinol taken for an unspecified indication, start and stop date were not reported. The patient previously took codeine and experienced Known allergy. Patient did not receive other vaccine in four weeks. Patient did not have COVID prior vaccination. Patient did not test COVID post vaccination. Patient experienced chest pains lasting 2 hours with light headedness, slow talking as well. Patient went to ER for this and when inlaid down the chest pain went away. ECG was normal as well as all blood work. Still feeling slight light headedness, the following day sporadically and my feet are cold as well feeling of left foot tingling when sitting or laying down on 23Feb2021 08:00 AM. Patient did not receive treatment for adverse events. The outcome of the events was recovering.
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| 40 | 2021-04-09 | feeling cold |
patient stated he was feeling cold and a tingling in his throat and started to have tunnel vision w...
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patient stated he was feeling cold and a tingling in his throat and started to have tunnel vision with a weird feeling. patient was assessed for vitals times 3 every 10minutes patient later after third set of vitals stated he was feeling back to normal patient was escorted back out to the exit of the building with his son also accompany him. patient was encouraged to encourage fluids, and to make sure to rest. patient vitals were as follows 9:19a b/p 135/92 p 93 r 18 o2 99% 9:25a b/p 134/84 p 83 r 18 o2 99% 9:30ab/p121/87 p86 r18 o2 98% patient was released and escorted to the car.
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| 40 | 2021-04-11 | hot flush, pain in extremity |
Left arm soreness lasted several days Flush feeling, chills, temp of 99.5-100.5, headache, left armp...
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Left arm soreness lasted several days Flush feeling, chills, temp of 99.5-100.5, headache, left armpit itching, weakness when standing, soreness in upper thighs.
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| 40 | 2021-04-11 | muscle spasms |
Severe upper body muscle cramps, fever and chills, minor nausea. Cramping in chest and diaphragm cau...
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Severe upper body muscle cramps, fever and chills, minor nausea. Cramping in chest and diaphragm causing moderate to severe positional pain and some difficulty breathing. Self treated with advil and tylenol. Laid flat on the floor for several hours in a position causing least amount of pain, until cramping subsided. Cramping lasted a total of 10 to 12 hours starting some time overnight after injection.
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| 40 | 2021-04-11 | seizure like phenomena |
Patient's behavior appears more in line with focalized or petit mal seizure activity. Gran Mal activ...
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Patient's behavior appears more in line with focalized or petit mal seizure activity. Gran Mal activity NOT witnessed.
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| 40 | 2021-04-12 | pain in extremity | Sore Arm and Overall fatigue the next morning. Strange taste in mouth. Metallic like. |
| 40 | 2021-04-12 | pain in extremity |
Sore Arm - lasted for 2 days Tinnitus in right ear - has been happening about 4 to 5 days after seco...
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Sore Arm - lasted for 2 days Tinnitus in right ear - has been happening about 4 to 5 days after second shot, has not stopped yet. No treatment.
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| 40 | 2021-04-13 | bell's palsy | bells palsy 8 days after administration of 1st dose |
| 40 | 2021-04-15 | tingling |
4/10/21, Swollen/ sore lymph nodes left arm pit. 4/12/21, Trouble swallowing food. Flare up of EoE ...
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4/10/21, Swollen/ sore lymph nodes left arm pit. 4/12/21, Trouble swallowing food. Flare up of EoE 4/13/21, Dizziness, low grade headache, tingling of skin on face and hands. Elevated response to seasonal and food allergies . Ongoing 4/15/21, Swollen/ sore lymph nodes right arm pit.
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| 40 | 2021-04-15 | tremor |
On the evening of March 6, 2021, patient tried to exercise (consistent with regular routine) and cou...
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On the evening of March 6, 2021, patient tried to exercise (consistent with regular routine) and couldn't do more than 15 minutes. He was very winded. On March 7, we skipped exercise. On March 8, patient tried to do simple stretching exercise, and couldn't do it. He got winded and shaky. On March 9, he was seen at an urgent care where he was told he had an inverted T wave on his EKG and a very fast heart rate (125 resting pulse). He was told to not exercise and to make an appointment with a cardiologist. On March 9, I called the urgent care clinic to ask questions about monitoring his blood pressure and when to seek more medical care. I spoke with Dr, who prescribed Atenolol. Around 4:30 pm on
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| 40 | 2021-04-16 | flushing |
Metallic taste in mouth, shoulder/neck stiffness, headache and went flush. Returned to normal within...
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Metallic taste in mouth, shoulder/neck stiffness, headache and went flush. Returned to normal within two hours
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| 40 | 2021-04-16 | tremor |
note I was moderately anxious prior to getting the vaccine and had a busy day the next day which was...
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note I was moderately anxious prior to getting the vaccine and had a busy day the next day which was worrisome in case of side effects. dizzy first day, chills, fast heart. Everyday so far feel off and on tired, dry mouth off and on, dehydrated? Felt tired within an hour of injection on Tuesday. I don't remember if my stomach was growling on the first night on the day I got injected and I just went to bed. The next morning I woke up really thirsty/hungry and tired. I slowly made myself breakfast. Sat down to eat on a stool and felt dizzy. My heart raced for 30 sec as I carefully made my way to the flow to be safe. I had the chills, a bit shaky for a short period. I called my doc who told me to stay hydrated. The clinic where I got injected DID NOT inform me about dehydration. As of today, I still have off and on a dry mouth, feel more of an empty stomach at meal time, tired off and on, and maybe dehydrated. I work from home so I am not pushing myself. I have not felt dizzy again and am decent at taking in water now.
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| 40 | 2021-04-17 | numbness | Numbness in some fingers; Numbness in some toes |
| 40 | 2021-04-17 | tremor, tingling |
Vivid/lucid dreaming with bright lights; Vivid/lucid dreaming with bright lights; light headiness a ...
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Vivid/lucid dreaming with bright lights; Vivid/lucid dreaming with bright lights; light headiness a feeling that i would pass out or die and tingling and shakimg; tingling and shaking throughout his body; tingling and shaking throughout his body; As he remained in a confused mental state; received bnt162b2 first dose on 10Mar2021, second dose on 24Mar2021; received bnt162b2 first dose on 10Mar2021, second dose on 24Mar2021; nocturnal panic attack with unknown trigger; Occasinally elevated blood pressure; slight markings of dehydration; hangover; This is a spontaneous report from a Contactable consumer (patient). A 40-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, brand: Pfizer), second dose via an unspecified route of administration, administered in arm left on 24Mar2021 11:30 at age of 40-year-old (Lot Number: ER8733) at single dose for COVID-19 immunization. The most recent COVID-19 vaccine was administered at Facility of Doctor's office/urgent care. Medical history included gout, anxiety, gastrooesophageal reflux disease, 'espoghutis'. The patient did not have allergies to medications, food, or other products. Concomitant medication within 2 weeks of vaccination included omeprazole; allopurinol; escitalopram. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took first dose of bnt162b2 via an unspecified route of administration, administered in arm left on 10Mar2021 11:30 at age of 40-year-old (Lot Number: En6206) at single dose for COVID-19 immunization. On 02Apr2021, the patient had vivid/lucid dreaming with bright lights and unusual feelings as he initially fell asleep. He was able to wake himself up but remained in between sleep and awake. This was accompanied by light headiness a feeling that he would pass out or die and tingling and shaking throughout his body as he remained in a confused mental state while his wife called an ambulance. In 2021, his vitals were fine with occasionally elevated blood pressure and slight markings of dehydration ( during the day following his second dose he felt like he had a bad hangover). The ER doctor thought the most likely explanation is sometime of nocturnal panic attack with unknown trigger. He had not previously sufferer anything like it. The events were reported as non-serious. The adverse events result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient received treatment for the adverse events which included: drugs to calm, fluids. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events light headiness, tingling and shaking throughout his body, confused mental state, nocturnal panic attack with unknown trigger, vivid/lucid dreaming with bright lights, elevated blood pressure, slight markings of dehydration, hangover were resolving. Information on lot/batch number obtained. Further information is expected.
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| 40 | 2021-04-18 | cold sweat |
ER Nursing Intervention/Reassessment [Charted Location: EMR-Emergency Rm Service] [Authored: 04/16...
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ER Nursing Intervention/Reassessment [Charted Location: EMR-Emergency Rm Service] [Authored: 04/16/2021 15:18]- for Visit: 004092726008, Complete, Revised, Signed in Full, General IV: IV Intervention: ? IV IV INTERVENTION/REASSESSMENT ? IV 1 Date 04/16/2021 ? IV 1 Time 14:25 ? IV IV 1 ? IV 1 Size 20G ? IV 1 Type peripheral iv ? IV 1 Inserted By inserted per RN ? IV 1 Side right ? IV 1 Right antecubital ? IV 1 Actions flushes easily labs obtained ? IV 1 Dressing needleless valve placed, catheter secured, transparent dressing applied with date/time/initials transparent semi-permeable dressing applied ? IV 1 Response pt. tolerated well pt instructed to call RN for problems ? IV 1 Total Attempts 1 COVID Screening Questions: COVID Screening Questions: ? Have you had a COVID-19 vaccine in the last 7 days? Yes (1) ? Was this COVID-19 vaccine your: First dose (1) Assessment Date / Time: ? Date/Time 04/16/2021 14:25 History of Present Illness: Chief Complaint: ? History of Present Illness allergic reaction ? Onset Time/Last Seen Normal 04/16/2021 13:15 Skin Assessment: Skin Assessment: ? Skin cool diaphoretic ? Mucous Membranes moist intact COVID Screening Questions: COVID Screening Questions: ? Have you had a COVID-19 vaccine in the last 7 days? Yes ? Was this COVID-19 vaccine your: First dose ER Triage Note: ? Triage Date/Time 04/16/2021 14:21 ? Triage Chief Complaint medical, Allergic Reaction to Covid Vaccine ? Additional Triage Comments Pt states he went home after receiving his Covid Vaccine (Phizer) when he noticed he was itching on his back. Pt arrived to ED with generalized erythema, skin cool and clammy, and wheezing. Pt denies contact with chemicals or anything else. ? Have you been sexually assaulted? no ? Stroke Screening no ? Pregnant/Could be pregnant not applicable ? LMP not applicable ? Tetanus <5 years ago ? Immunization up to date yes ? CDC Early Warning Symptoms None Identified ? CDC Precautions standard precautions mask applied Infectious Disease: Infectious Disease: ? Have you traveled recently? No ? Do you have any of the following symptoms? none Mode of Arrival: ? Mode of Arrival private auto Height/Length - Weight for Calculation: Weight for Med Calculation: ? Height (ft) 6 Feet ? Height (remainder in inches) 0 Inch ? Height (cm) 182.8 cm ? Body Measurements stated ? Weight for Calculation (kg) 108 Kg ? Weight Method stated ? BSA (m2) 2.29 M2 ? BMI (kg/m2) 32.3 kg/m2 Triage Vital Signs: ? Temp (degrees F) 97.1 degrees F ? Temp (degrees C) 36.1 degrees C ? Method skin/temporal ? Heart Rate (beats/min) 118 bpm ? Respiration (breaths/min) 18 ? BP Systolic (mm Hg) 156 mm Hg ? BP Diastolic (mm Hg) 103 mm Hg ? Sitting BP right upper arm ? SpO2 Patient On room air ? SpO2 (%) 98 % Treatment Prior to Arrival: ? Treatment Prior to Arrival none Allergies: Allergies/Intolerances: Allergies: ?? Pfizer-BioNTech COVID-19 Vaccine: Anaphylaxis ?? tramadol: Hives Home Medications - OMR: Home Medications - OMR: * Patient Currently Takes Medications as of 04/16/2021 15:11 documented in Structured Notes ?? losartan 50 mg oral tablet: None, 1 tab(s) orally once a day, Hx, Status: Active, Quantity: 0, Refills: None, Last Dose Taken: ?? Albuterol (Eqv-ProAir HFA) 90 mcg/inh inhalation aerosol: None, 2 puff(s) inhaled every 6 hours, Hx, Status: Active, Quantity: 0, Refills: None, Last Dose Taken: Patient Seen Time: ? Patient Seen Time 04/16/2021 14:21 ? LMP not applicable ? Tetanus <5 years ago ? Immunization up to date yes Triage Vital Signs: ? Temp (degrees F) 97.1 degrees F ? Temp (degrees C) 36.1 degrees C ? Method skin/temporal ? Heart Rate (beats/min) 118 bpm ? Respiration (breaths/min) 18 ? BP Systolic (mm Hg) 156 mm Hg ? BP Diastolic (mm Hg) 103 mm Hg ? Sitting BP right upper arm ? SpO2 Patient On Pulseox: 98 % on RA @ bedside monitor -- normal ? SpO2 (%) 98 % ? Acuity Level 3 Preferred Pain Scale: Preferred Pain Scale Numeric Pain Scale© Numeric Pain Score - Rest© 0 - No Pain Numeric Pain Score - Activity© 0 - No Pain Treatment Prior to Arrival: ? Treatment Prior to Arrival none Nursing Documentation Review: ? Triage Review I have reviewed the above Vital Signs, Nursing Documentation and Triage Assessment. Arrived From: ? Arrived From home home after leaving vaccination clinic HPI: ? HPI CC: rash/itching HPI: history from patient He describes Covid just after receiving the Pfizer vaccine, his initial dose. By the time that he returned home he had opened up a soft drink was having some slight cough, trouble swallowing and had sensation of itching on his back. He asked his mother to check his back and it was discovered that he was starting to have rash over his body. This seemed to be persistent and he returned to ER for further evaluation/treatment. He has not had reaction to vaccination in the past. He does have allergy to tramadol. He denies having any allergy to soap, detergent, or other chemicals. He denies having exposure to any chemical, fume, dust, plant material after receiving the vaccination. He denies having any new foods or drinks recently. He is not having any nausea or vomiting. He has felt somewhat sweaty. Allergy: tramadol H/O LE muscle weakness/atrophy , COPD ROS Const: No fever, chills, sweats. No unusual weakness (he does note "my leg is atrophying" when he is speaking about his LLE) HEENT: No runny nose, congestion, ear ache. Perhaps some odd sensation in the throat due to swollen uvula. CV: No chest pain, palpitations. No unusual shortness of breath. No edema to the ankles / legs. No pain with breathing. Abdom: No nausea, vomiting, diarrhea, or constipation. No abdominal pain. Lymph: No swelling to glands. Physical Exam: ? Physcial Exam A&O, nontoxic. Pleasant. No pain distress. Mild physiologic distress. Appears to be overwt adult with component of chronic illness and with acute allergic reaction/process_. Eyes: EOMI, nonicteric, conjunctiva clear. Throat: Moist mucous membranes. Symmetric rise of palate. No pharynx erythema. Tonsils normal size and without erythema or exudate. His uvula is moderately edematous and elongated. He is managing his secretions well. There is no angioedema of the tongue, soft palate, lips. No stridor. No blood in the oropharynx. No rhinitis/runny nose. Neck: supple, normal ROM, nontender. trachea midline. No cervical or supraclavicular lymphadopathy. Thyroid nontender and normal size. Back: No pain on percussion. No muscle spasm. Nontender palpation. No kyphosis. Lungs: fair to good air movement with quiet, fine primarily inspiratory wheezes in the mid to lower lung fields. nl effort, no rales, crackles, rhonchi. Normal resonance on percussion. Cough clear. Cardiac: borderline tachy RRR S1, S2, without murmur or rub. Posterior tibial, Pedal pulses 2/4 bilaterally. No ankle or pretibial edema. Skin: cool & dry extermities. cool & moist (not diaphoretic) back skin. Normal turgor. He does have confluent macular rash to the neck, (somewhat on face), arms, back/chest/abdomen. Some mild hyperemia to the legs/ankles. No urticaria. The right deltoid injection site is involved with the hyperemia/macular rash but no urticaria at this location right now Abdom: Bowel sounds present x 4 Quadrants. Normal tympany to percussion. Soft. Non-distended. Nontender. Nonsurgical. Good muscle tone and moves all extremities. He notes he has his chronic weakness in his left lower extremity. Medical Decision Making: ? Discussed with another healthcare provider Discussed case with another healthcare provider ? Consultation Consultation 1, Consultation 2 ? Consultation 1 04/16/2021 15:54 ? Consultation 1 Comments discussed with RPh. He will come to ER to obtain additional information from patient. This is the hospital's first presumptive Pfizer vaccine reaction. ? Consultation 2 04/16/2021 15:41 ? Consultation 2 Comments discussed with Dr. we discuss presentation. he agrees pt will need monitoring with the persisting symptom/findings and the H/O COPD. 1617 Dr has been to ER and completed eval. pt to be placed on 2nd floor med/tele for additional monitoring and treatment. pt did have labs yesterday. ? Decision to Admit Based On 1446 Based on his symptoms and presentation presumptive acute anaphylaxis to component of the Pfizer Covid vaccine. We will begin treatment with 0.3 mg epinephrine IM once as well as dexamethasone, famotidine, diphenhydramine IV. We will continue to monitor with cardiac telemetry and pulse oximetry. He does have slight wheezing but this may be related to his chronic COPD. No respiratory distress at this time, but his symptoms seem to have been mildly progressive over the past hour (per his report). I believe inclusion of the epi to be prudent based on his presentation. Additionally, I will inform the vaccination clinic of this reaction. he agrees pt will benefit from continued monitoring and repeated IV antihistamine and IV steroid treatment. Pt will need IVFluid for hydration as well. Recheck: ? Recheck Recheck 1, Recheck 2, Recheck 3 ? Time 14:55 ? Recheck patient stable patient improving with treatment ? Comments He is improving. His skin is now warm and moist (not sweatty , not diaphoretic). The rash is receeding from the arms. Good coloration to the legs/ankles. Back & torso rash starting to recede. no nausea/vomiting. no difficulty breathing. still with fading macular rash on the torso and upper back. Lungs: improved air movement compared to the initial exam, nl effort, no rales, crackles, rhonchi. He has lower field (only) quiet fine inspiratory wheezes. Normal resonance on percussion. Cough mildly wheeze @ bases, with improved airflow. Cardiac: borderline tachy RRR S1, S2, without murmur or rub. Posterior tibial, pedal pulses 2/4 bilaterally. No ankle or pretibial edema. ? Time #2 15:05 ? Recheck #2 patient stable patient improving with treatment ? Comments #2 man from pharmacy is here and recognizes patient from the vaccination clinic. Patient rash has faded from his extremities fully and appears to have faded from his abdomen still somewhat at the malar area of the cheeks as well as the neck and torso portion of the chest. His pulse is 98?99 continues to have elevated blood pressure. Pulse oximetry 98-100% on room air, normal. Pharmacist will enter the reaction into the CDC/FDA/Pfizer database. Overall pt notes he feels tired (probably related to hydration & benadryl). He notes he has returned to home about 2 weeks ago after spending some time on the road in mountains playing guitar / touring with a small band , playing music. ? Time #3 15:37 ? Recheck #3 patient stable ? Comments #3 He has been resting. No respiratory distress. His blood pressure and pulse and pulse oximetry are reviewed at bedside and they are nonfocal at this time. Overall he is improving. He notes he still has malaise and feels about the same with itching in his back and the sensation in his throat. When I evaluate his back there is hyperemia/some macular rash that is in approximately the distribution of the trapezius muscle of the back this is where he notes he has the itching. Additionally when I evaluate his throat there is still some presence of uvula edema. There is no other angioedema. Perhaps he does have some mild hyperemia to the uvula and soft palate at this time. He is clinically improving but his symptoms have not resolved fully. Skin warm and dry normal turgor. No diaphoresis Lungs initially some coarseness/mucousy breath sounds to the mid lower fields but this clears after he coughs. Good air exchange at this time. No rales rhonchi wheezes or crackles. Cough initially mucousy then clear. managing secretions well. no stridor. no respiratory distress. Critical Care Times: ? Critical Care Time of minutes excluding, separately billable procedures 35 Disposition Summary: Arrival 04/16/2021 14:21 Disposition to be admitted Disposition Decision Date/Time 04/16/2021 15:54 Does an Emergency Medical Condition Exist at the time of D/C? yes Condition at Disposition Stable Alert and Oriented Guarded Emergency Diagnosis: ?? History of COPD (Z87.09): Entered Date: 04/16/2021 15:59, ICD-10: Z87.09 ?? Anaphylaxis due to immunization (T80.52XA): Entered Date: 04/16/2021 15:59, ICD-10: T80.52XA ?? Drug reaction, initial encounter (T50.905A): Entered Date: 04/16/2021 15:59, ICD-10: T50.905A PCP Summary: ? PCP , ? Select Follow-up Physician Follow Up Physician #1 Follow Up Physician #2 ? Follow-Up MD ? Group Name Primary Care ? Specialty ? Follow-Up MD ? Fax Number ? Follow Up In 04 days Instructions: ? Other Instructions Return to ER for worsening symptoms or other concerns ? Additional Instructions Patient has had clinical improvement and stabilization although he is not fully resolved of his symptoms. He is placed into the hospital for further evaluation and management under Dr. Note Complete: Note Complete This document is complete. Affix my electronic signature. Last Updated: 04/16/2021 16:19 by (MD) References: 1. Data Referenced From "ER MD Exam and Disposition" 04/04/2021 17:40 2. Data Referenced From "1. Vital Signs - Adult" 04/16/2021 14:30
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| 40 | 2021-04-18 | muscle spasms |
4/10-1945 Caller states patient had flu like symptoms post vaccine. headache fatigue fever diarrhe...
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4/10-1945 Caller states patient had flu like symptoms post vaccine. headache fatigue fever diarrhea Cramps. Cramps and Diarrhea has continued and is still every 15 minutes . Advised to seek medically attention diarrhea every 15 minutes for days needs medical attention . 4/11-Patient's spouse returned call, patient continues with diarrhea, not as many bouts as yesterday, started taking Immodium as directed today. Will follow up tomorrow. 4/12-Follow Up: He stated he didn't go to the urgent care he just took Pepto Bismol and Loperimide to help with diarhea (which help tremendously). As of 4/11/21 he stated all his symptoms have subsided (diarrhea, headache, etc) and feels a lot better.
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| 40 | 2021-04-19 | flushing |
"Administered - 4/19, time unknown Adverse event started - 10:06 Patient had syncope, flushing/sweat...
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"Administered - 4/19, time unknown Adverse event started - 10:06 Patient had syncope, flushing/sweating. BP 109/53 -- > 114/55, HR 68 -- >64, RR 16 -- >16 , O2 100% -- > 99%, Temp 97.3F. Given PO juice, Graham crackers. Patient stable, released from vaccination site."
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| 40 | 2021-04-19 | pain in extremity, numbness | dyspnea, tachycardia, pain in arm with swelling, numbness, bruising |
| 40 | 2021-04-20 | discomfort |
Shingles developed on back and arms. Painful, raised rash causing stinging and discomfort, Anti vir...
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Shingles developed on back and arms. Painful, raised rash causing stinging and discomfort, Anti viral meds prescribed as well as pain medication
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| 40 | 2021-04-21 | bell's palsy |
Bell's Palsy diagnosis: can't move my right face muscles. Treatment: Prednisone (for 10 days) and Va...
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Bell's Palsy diagnosis: can't move my right face muscles. Treatment: Prednisone (for 10 days) and Valtrex (for 7 days)
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| 40 | 2021-04-21 | bell's palsy | Bells Palsy |
| 40 | 2021-04-21 | numbness |
Ii got he vaccinator on 3/5 and went home. the first night around 9p, I started to feel chills, Had...
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Ii got he vaccinator on 3/5 and went home. the first night around 9p, I started to feel chills, Had a really big temporal headache. I thought it was a reaction to vaccination, I took Tylenol PM, layer down and woke up in the middle of the night, in a full body sweat. I went strait into chills, changed my clothes. Layed back own and awoke the next morning, with chills and temp of 101. I had body ache but proceeded with my day. I continued to have chills, I went out to my elderly parents, took them food and had dinner. Upon arrival home, had high fever 103...no Tylenol. Awoke still w/ chills and high fever and this was Sunday. Stayed in Sunday then the afternoon, felt like I needed to seek help. I went to get a rapid test at Medical Center and it came back Neg. Went back home, I could now sense that my taste was altered. I then continued to have a high fever but they would only come at night. Body sweat, aches, chills cont'd on Sunday. Monday still had same s/s and Tuesday, I thought that I should seek more medical attention. I went to an Urgent Care 3/9/21. They then did a nose swab and felt that it would come back Neg. I went home and on Thursday 3/11/2021 I got a call that I was positive. Did isolate. But from 3/5 to 3/11 then I lost taste/smell. Came out of isolation 3/20 and on 3/21 my whole left side of fact, shoulder and leg went numb for approx 1hr. Then my wife said that I was talking a little slow in my response. Next morning my left shoulder was hurting and I had pain. The Urgent care provider wanted to r/o TIA so he sent me to ER for full work up and that doctor said he saw nothing. He didi say that it could be Covid related and/or possible TIA. "I am feeling good today" There is no residual but because of the left shoulder pain I did go back to Urgent Care. Got cortisone inject and MRI. My PCP then told me that I had a partial "tear" in my left shoulder but I do exercise every day and could have done it then.
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| 40 | 2021-04-21 | nerve pain |
2nd dose of the vaccine was given on Thursday April 15 , Three days after the Injection. On Sun the ...
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2nd dose of the vaccine was given on Thursday April 15 , Three days after the Injection. On Sun the 18 , I started have painful rash and deep nerve pain on my upper forehead and left ear. After a visit to the doctors On Tuesday the 20 It was announced I had Shingles. It has been slowly spreading over my scalp and on my face.
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| 40 | 2021-04-22 | pain in extremity |
Pain around injection site on the left arm one week after covid vaccine, with shingles developing at...
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Pain around injection site on the left arm one week after covid vaccine, with shingles developing at the same time on the left side of my neck chest and neck.
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| 40 | 2021-04-23 | migraine |
After 5-6 days I broke out into sever shingles in the buttocks area, several other symptons as well ...
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After 5-6 days I broke out into sever shingles in the buttocks area, several other symptons as well like difficulty urinating, chills, migraine
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| 40 | 2021-04-23 | tingling | Pins and needles sensation through out my body, mainly in my feet |
| 40 | 2021-04-24 | numbness |
My leg was numb; Felt swollen from my right leg.; This is a spontaneous report from a contactable co...
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My leg was numb; Felt swollen from my right leg.; This is a spontaneous report from a contactable consumer. A 40-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Er8727), via an unspecified route of administration in Left Arm on 26Mar2021 04:30 PM as single dose for covid-19 immunization. Medical history included allergy to fish. The patient's concomitant medications were not reported. On 26Mar2021, 04:45 pm the patient reported his leg was numb and felt swollen from my right leg. Until he took a Benadryl, the feeling in leg came back after hour. The outcome of event was recovered on an unknown date in 2021. Information on the lot/batch number has been requested.
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| 40 | 2021-04-24 | pain in extremity |
Temporary symptoms include headache (gone the next day), sore arm (lasted a few days), chills (the n...
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Temporary symptoms include headache (gone the next day), sore arm (lasted a few days), chills (the next day only), and tiredness (for a couple days). However, I have experienced tinnitus starting the evening of injection, and it hasn't disappeared or even dampened since.
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| 40 | 2021-04-24 | tingling |
Pins and needles, tingles in fingers, both hands, arms, and sometimes other parts of the body, inclu...
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Pins and needles, tingles in fingers, both hands, arms, and sometimes other parts of the body, including neck, feet. The sensation comes and goes multiple times per day, sometimes severe, and feels strong during the night / morning.
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| 40 | 2021-04-25 | pain in extremity |
Sore arm. Headache, dizziness, fever (treated with Tylenol), fatigue. Sore arm a few hours after inj...
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Sore arm. Headache, dizziness, fever (treated with Tylenol), fatigue. Sore arm a few hours after injection worsening the next day (not treated). Headache starting about 8am the next morning. Fever starting about 9am. Did not slow down or rest all day. Performed mentally challenging tasks. Drank plenty of fluids. Fatigue hit hard about 8pm.
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| 40 | 2021-04-26 | weakness, flushing |
Systemic: Fainting / Unresponsive-Medium, Systemic: Fell from chair and hit head on floor - small ga...
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Systemic: Fainting / Unresponsive-Medium, Systemic: Fell from chair and hit head on floor - small gash on bridge of nose-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Hypotension-Medium, Systemic: Weakness-Medium, Additional Details: Within 5 minutes of vaccination, pt fell from sitting position in chair to the ground. Pt hit his head and had small gash on bridge of nose. When I got to him, his eyes openned and he knew what happenned. Called 911. He laid on ground while we had NP check blood pressure, pulse, and O2 levels. Pt was stable and walked out with EMS to be checked out.
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| 40 | 2021-04-26 | tremor, pain in extremity |
Hit by a train (figuratively), Sore Arm, High Fever (102.1), Vomiting, Diarrhea, Headache, Close to ...
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Hit by a train (figuratively), Sore Arm, High Fever (102.1), Vomiting, Diarrhea, Headache, Close to fainting, Shake, Chills, Loss of Appetite (didn't eat for 10 days), Fatigue. Symptoms were intense for 2 days, then were mild for 2 days.
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| 40 | 2021-04-26 | unresponsive to stimuli |
Patient found unresponsive and transported to ED. Currently hospitalized and admitted with following...
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Patient found unresponsive and transported to ED. Currently hospitalized and admitted with following issues: Present on Admission: ? Intraventricular hemorrhage (HCC) ? Bilateral thalamic hemorrhage ? Acute encephalopathy ? Abnormal eye movements ? Respiratory failure requiring intubation (HCC) ? Mucoid impaction of bronchi
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| 40 | 2021-04-26 | unresponsive to stimuli |
Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Confusion-Severe, Systemic: Fainting / Un...
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Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Confusion-Severe, Systemic: Fainting / Unresponsive-Medium
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| 40 | 2021-04-27 | weakness |
4/24 - low-grade fever (99.5 F), muscle aches, headache, lasted all day + all night 4/25 - low grade...
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4/24 - low-grade fever (99.5 F), muscle aches, headache, lasted all day + all night 4/25 - low grade fever continued (99.5 F), sweats/chills, sharp headache, fatigue, muscle aches 4/26 - low grade fever continued (99.5 F, dropped to 99.3 F in evening), sweats/chills continued, sharp headache continued, fatigue + aches continued 4/27 - low grade fever (99 F), sharp headache, chest pain when coughing, developed sinus congestion, wet cough which produced mucous (clear), slight fatigue and aches (lessened), new symptom of low humming tinnitus in left ear only (when surroundings quiet) 4/28 - fever gone for 18 hours w/o fever-reducing medication, fatigue still present, cough with phlegm still present, slight headache, slight sinus congestion, low humming tinnitus in left ear continues (when surroundings are quiet)
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| 40 | 2021-04-27 | tingling | Tingling, pins-and-needles feeling on the bottoms of the feet. |
| 40 | 2021-04-28 | numbness | Numbness in my left hand and fingertips |
| 40 | 2021-04-28 | pain in extremity | Fatigue on 2nd day and 9 days later still have Covid arm (dull pain) in right upper arm and deltoids |
| 40 | 2021-04-28 | tremor |
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Swelling of Fa...
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Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Shakiness-Mild
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| 40 | 2021-05-02 | weakness |
patient experienced onset of fevers, headache, neck pain, generalized malaise/fatigue/weakness, diar...
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patient experienced onset of fevers, headache, neck pain, generalized malaise/fatigue/weakness, diarrhea/abd pain, with 2 ED visits ultimately admitted to hospital and diagnosed with MIS-A with elevated bnp, troponin, and inflammatory markers, and treated with dex 6mg x 10 days with complete resolution on follow-up.
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| 40 | 2021-05-04 | bell's palsy |
I've developed bell's Palsey; This is a spontaneous report from a contactable consumer. A 40-years...
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I've developed bell's Palsey; This is a spontaneous report from a contactable consumer. A 40-years-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 10Apr2021 (Batch/Lot Number: EW0162) as a single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient did not have any other vaccinations within 4 weeks. The patient reported that on 17Apr2021, he developed bell's palsey. The outcome of the event was not reported. The patient did not have COVID prior to vaccination not was tested post vaccination.
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| 40 | 2021-05-04 | seizure |
Had seizures and ended up in emergency room; Had seizures and ended up in emergency room; scar in le...
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Had seizures and ended up in emergency room; Had seizures and ended up in emergency room; scar in left arm/scar in his left arm before he had a seizure; 'he could feel a bump, it was like a bump in there. So, it was between his armpit his heart where he felt the bubble; This is a spontaneous report from a contactable consumer (parent). A 40-year-old male patient received the second dose of BNT162B2 (lot number and expiry date were not reported), via an unspecified route of administration, administered in left arm on 14Apr2021 (at the age of 40-year-old) as single dose indicated to prevent from Corona virus (Covid-19 Immunization). Medical history included seizures and gout. The patient's concomitant medications included unspecified medication for seizures. The patient previously received the first dose of BNT162B2 (lot number: ER8730) on 24Mar2021 for Covid-19 Immunization. The patient got the second Pfizer shot later this month, left the office, 45 minutes later (on 14Apr2021) he had seizures and ended up in emergency room. He has had small seizures but they are not back to back, of and on throughout the years and now we are saying that maybe COVID Vaccine shot is what provoked him to, what made him had seizures. Reporter stated, even though he has had seizures in the past like it could be 2, 3 years apart for one. But the shot it caused him to have another seizure, but he is not going to continue to have seizures, as he is on medication (unspecified medication) right now. But the medication is on, if they take him off it, he could have multiple seizures constantly (name of medication not clarified further). Also on 14Apr2021, the patient also had a scar in left arm, it is another symptom he had. He had the scar in his left arm before he had a seizure, he said over here between his heart and his arm felt like a (incomplete sentence), now they don't know if he had a one scar or what it says but he says that 'he could feel a bump, it was like a bump in there. So, it was between his armpit his heart where he felt the bubble' (not clarified further). The patient underwent laboratory test which included: blood work, a urine sample and they did a CAT scan to see knowing the problem in his brain, all on 14Apr2021 with unknown result. The day of the test was on the 14th, it would have been on a Wednesday. It was the same day that he got the second shot. So, he had these test done on 14Apr (14Apr2021). Reporter confirmed of getting the test results on Thursday, so did not have the details. Therapeutic measures were taken as a result of seizures which included Levetiracetam 500 mg tablet, he takes one tablet twice a day, so he takes two tablets a day. This was ordered by his doctor in emergency room. The outcome of the events was unknown. Information on the lot/batch number has been requested.
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| 40 | 2021-05-11 | discomfort |
part of my left kidney was no longer receiving blood; blood clot; placed on stroke protocols.; I dev...
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part of my left kidney was no longer receiving blood; blood clot; placed on stroke protocols.; I developed severe abdominal pain in my left side during the evening; lack of appetite; bouts of severe discomfort; This is a spontaneous report from a contactable consumer (patient). A 40-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EW0167) via an unspecified route of administration, administered in Arm Left on 28Apr2021 12:15 (40-years-old) as 2nd dose, single for COVID-19 immunization. The patient medical history was not reported. Vaccination Facility Type was clinic. Concomitant medications included ibuprofen (ADVIL); desloratadine (CLARINEX). The patient previously took first dose of BNT162B2 (lot number=EN6208) on 07Apr2021 01:15 PM (40-years-old) on Left arm for COVID-19 immunization. It was reported that the patient developed severe abdominal pain in my left side during the evening of Wednesday, 28Apr2021 19:00. The pain appeared sporadically throughout the evening and continued through Friday, April 30. During this time, he experienced a lack of appetite and bouts of severe discomfort. Tried treating with GasX and Tylenol. Duration of Hospitalization reported as 3 days. On Saturday, 01May2021, starting around 10:30 a.m., the pain in his left-side abdominal area intensified and did not diminish. After 6 hours, he visited the ER at hospital. After being admitted to the ER, a series of blood, urine and imaging tests were performed on me. The doctor on duty reported that a CT scan showed that part of my left kidney was no longer receiving blood (disability). He was placed on Heparin and admitted to the hospital. He was diagnosed with a blood clot and placed on stroke protocols. The adverse event result in Emergency room/department or urgent care. Treatment received for the adverse events was Heparin, fluids, blood work, urine analysis. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events abdominal pain, lack of appetite, and bouts of severe discomfort was recovering; while other events was unknown. Events reported as serious due to hospitalization and life threatening.
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| 40 | 2021-05-24 | numbness, facial paralysis |
woke up in the middle of the night with right side numbness, and drooping face. Was rushed to the ER...
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woke up in the middle of the night with right side numbness, and drooping face. Was rushed to the ER. Stroke team diagnosed and began treatment of stroke. Had multiple tests run to include arterial ultrasounds, internal echo cardio, and CT and MRI of the brain. Confirmed left side of brain stroke but causes are still unknown. all tests and bloodwork came back normal and within range of an above average healthy adult.
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| 40 | 2021-05-25 | cold sweat |
Stomach cramps; Diarrhea; Cold sweats; This is a spontaneous report received from a contactable cons...
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Stomach cramps; Diarrhea; Cold sweats; This is a spontaneous report received from a contactable consumer, the patient. A 40-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: Ep6955) via an unspecified route of administration in the left arm on 15Mar2021 at 12:00 PM (at the age of 40-years-old) as a single dose for COVID-19 vaccination. The patient medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Mar2021, the patient experienced Diarrhea, cold sweats and stomach cramps. The patient was not treated for the adverse events. The clinical outcome of the events Diarrhea, cold sweats, and stomach cramps was resolved on an unknown date at the time of the report. No follow-up attempts are needed. No further information is expected.
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| 40 | 2021-05-26 | tingling, slurring |
50% loss of vision; Tingling on one side of body; Experienced Transient Ischemic Attack 1 week after...
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50% loss of vision; Tingling on one side of body; Experienced Transient Ischemic Attack 1 week after vaccine 2nd dose (April 27, 2021).; Strong pressure in head; loss of ability to support body in RL; Slurred speech; Difficulty in breathing; Cognitive difficulties; Extreme headache; This is a spontaneous report from a contactable consumer (patient) reported for himself that a 40-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot Number: EL7533) via an unspecified route of administration, administered in Arm Left on 20Apr2021 14:00 as 2nd dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient previously received first dose of BNT162B2 (Lot number EL8727) in the Left arm on 29Mar2021 16:00 at the age of 40 years for covid-19 immunisation. No known allergies. No vaccines were received within 4 weeks prior to the COVID vaccine. Healthy and no prior adverse event history. The patient experienced transient ischemic attack 1 week after vaccine 2nd dose, strong pressure in head, loss of ability to support body in RL, slurred speech, difficulty breathing, cognitive difficulties, extreme headache on 27Apr2021 16:30; visited emergency department. 2nd incident 02May2021- 50% loss of vision, tingling on one side of body, slurred speech, cognitive difficulties, extreme headache. The adverse events resulted in emergency room and healthcare professional office visit. Patient was treated with headache medications. It was reported that patient was recovered from events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events was recovered in 2021. Information on Lot/Batch number was available. Additional information has been requested.
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| 40 | 2021-05-27 | pain in extremity |
I was awoken from sleeping on the morning of Good Friday at 4:00 am. i had a very sharp pain at the ...
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I was awoken from sleeping on the morning of Good Friday at 4:00 am. i had a very sharp pain at the front of my left shoulder that went about halfway down my left arm. Additionally, I couldn't breath - it was very painful to attempt to fully fill my lungs. This condition lasted for about 45 minutes as I tried changing positions in bed to make the pain change (either worse or less) but it was consistent and would not go away. At that time my wife and I thought I may have been having a heart attack so we went to the Emergency Room.
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| 40 | 2021-05-28 | cold sweat, flushing, unresponsive to stimuli |
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flus...
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Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Weakness-Medium, Additional Details: pt's forehead felt cold and sweaty and he tried to lift his legs up and kept his hands high - he described that he faints after a blood taken for a test or after a vaccing, and this might be a mental predisposition to this reaction. we called an embulance, but patient felt better in 5-7 min and requested to cancel embulance. He spent 10-20 min on the chair and felt ok to get up and walk around. He left stating he fill better.
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| 40 | 2021-05-28 | numbness, tingling |
Walking to the observation room approximately 2 minutes post shot I felt extreme dizziness. Felt li...
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Walking to the observation room approximately 2 minutes post shot I felt extreme dizziness. Felt like I could potentially pass out so I waited 30 minutes in the observation room before leaving. After I was fairly confident I would not pass out I left the facility. When I made it outside it felt like the right side of my brain was "not there," like a portion of my brain was dead. While driving home approximately 45 minutes post shot I felt numbness and tingling on the right side of my face. Mental confusion also started. I don't recall the numbness and tingling in my face continuing at this time. Proceeded home, laid down on the couch to relax and about 3 hours post shot felt my heart racing. Checked heart rate with pulse oximeter and heart rate was 120 w/98 oxygen. 5 minutes later the heart rate went down to around 90 but blood oxygen went to 90. I sat up, drank water and pulse/oxygen returned to normal. The next day the mental confusion continued. Approx. 24 hours post shot tingling and numbness felt on right side of face. Couldn't move lips properly, communicate to my facial muscles. This lasted around an hour or two. 30 hrs post shot short term memory loss caused confusion when typing texts, following conversation, etc. Symptoms improved greatly over the next couple of days. Tiredness/general unwell feeling approximately 48hrs post shot but unremarkable. By the time I went to a GP 84hours post shot I felt 95%. Went to a neurologist 108hrs post shot who performed standard tests and all was well. 1 week post shot got into an argument and felt tingling and numbness on right side which lasted approximately 10 seconds.
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| 40 | 2021-05-31 | pain in extremity |
Pain in arm for about 48hrs/Pain was moderate; This is a spontaneous report from a non-contactable c...
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Pain in arm for about 48hrs/Pain was moderate; This is a spontaneous report from a non-contactable consumer, the patient. A 40-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number; Unknown) via an unspecified route of administration on the right arm on 14Mar2021 at 16:00 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history of the patient included GERD and asthma. The patient was allergic to Penicillin. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included Omeprazole since an unknown date for an unknown indication. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccine. The patient took penicillin on an unknown date for an unknown indication and experienced allergy. On 14Mar2021, the patient experienced pain in arm for about 48hrs.The patient also reported that the pain was moderate. No treatment received for the event. Therapeutic measure taken for the adverse event was unknown. The outcome of the event pain in arm was recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained Amendment: This follow-up report is being submitted to amend previously reported information: Patient first name added. Patient's Age/Units captured as 40 years per event's onset 14Mar2021. Vaccination Facility added. "Unknown" removed from Lot# field. For both events: "Treatment Received?" captured as "No" per source "if treatment ae: No". Final sentence "Information about lot/batch number cannot be obtained. No further information is expected." updated as "No follow-up attempts are possible; information about lot/batch number cannot be obtained." Patient's Ethnic Group captured "Unknown" removed from Lot# field "OMEPRAZOLE". Event stop date captured as 16Mar2021 per verbatim "Pain in arm for about 48hrs". Yes removed from Concomitant Therapy since already coded out. In narrative, "This is a spontaneous report from a non-contactable consumer, the patient". In narrative, "Therapeutic measure taken for the adverse event was unknown" should be "no" per source "if treatment ae: No". Initial information need be updated in consolidated narrative: adverse event: Pain in arm for about 48hrs. Nothing more. Pain was moderate. if treatment ae: No
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| 40 | 2021-06-01 | hot flush |
Immediate nausea, hot flash and heart palpitations at time of injection, soreness for 3 days, and on...
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Immediate nausea, hot flash and heart palpitations at time of injection, soreness for 3 days, and on the 4th day I had a general feeling of malaise, which worsened until I developed a fever. Severe fatigue and constant fever as high as 105 for three days, and finally went to the ER. Immediately treated for sepsis. Full blood panel, blood cultures, x-ray and CT scan. Also ran some additional cultures for respiratory pathogens. The Dr?s had a tough time determining what it was. They saw a very small area which they called pneumonia, however, I?ve had pneumonia and this was not what it was. Final discharge paperwork stated Systemic Inflammatory Response Syndrome.
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| 40 | 2021-06-02 | pain in extremity |
Per Client received COVID 19 in right arm on 5/24/2021, soreness at injection site on same day of va...
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Per Client received COVID 19 in right arm on 5/24/2021, soreness at injection site on same day of vaccine. On 5/25/2021 around 4 am, started having chills and headache. On 5/26-5/27/2021 headache worsened and by Friday on 5/28/2021, along with headache, left sided pain in chest and arm. Per patient was taken to ER by wife and admitted to hospital on 5/28/2021. Per Client, was told first by hospital that he was having a heart attack. Client reported having labs collected, EKG, Catheterization and Ultra Sound. Per Client, later diagnosed with "myocarditis" and is now taking multiple mediations. Per Client was discharged from hospital on 5/29/2021, that evening. Will be following up with PCP in one week.
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| 40 | 2021-06-03 | pain in extremity |
Sore arm; This is a spontaneous report from a contactable consumer (patient). A 40-year-old male pat...
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Sore arm; This is a spontaneous report from a contactable consumer (patient). A 40-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: EN6205, Expiration Date: not reported), via an unspecified route of administration on 04Mar2021 at 09:15 (at the age of 40 years old) as first dose, single for COVID-19 immunisation in a Pharmacy or Drug Store.Medical history included high blood pressure from an unknown date. The patient's concomitant medications were not reported. The patient did not receive any other vaccines in 4 weeks, has no known allergies and prior to vaccine the patient was not diagnosed with COVID-19. On 04Mar2021 at 14:00 (reported as 02:00PM), the patient experienced sore arm. No treatment was received for the adverse event and since vaccination, the patient has not been tested for COVID-19. Outcome of the event was recovered on an unspecified date. No follow-up attempts are possible. No further information is expected.
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| 40 | 2021-06-06 | night sweats |
Loss of appetite, fever (102/103) and night sweats for the first 3 days. my chest pain on the left ...
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Loss of appetite, fever (102/103) and night sweats for the first 3 days. my chest pain on the left started the night of the shot around 2 am. The pain kept getting worse and worse each day. I finally had to drive myself to the emergency room (5/4/201) to get it checked out. It felt like something was squeezing my heart. i was super light headed and felt like i was going to drop on the floor dead. They gave me a chest x ray and took blood work. Everything cam back good and the doctor said if i kept getting those chest pain i should return. so they let me go. i still kept getting my chest pain for another week. however i didnt go back to the ER, because i was scared of getting a second bill as im not insured.
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| 40 | 2021-06-06 | seizure, weakness, feeling hot |
Within about 5 minutes of patient of patient receiving the vaccine, he had a seizure in the lobby of...
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Within about 5 minutes of patient of patient receiving the vaccine, he had a seizure in the lobby of the pharmacy. The seizure was not witnessed by any employee, but by his companion and a customer. I immediately had a technician call 911 and ran out with our emergency kit when I heard the patient's companion screaming for help. When I got to the patient he was in a seated position in a chair in the lobby and was coming to. He was disoriented and looking around. I asked if he knew his name and what day it was, he did know. I asked if he knew where he was and he responded correctly. He said he felt week and hot, he appeared sweaty. I checked his blood pressure (100/58) and pulse (50 bpm). His temperature was 97.1. His companion stated he had never had a seizure before when asked. I gave him some water and sat with him until EMS arrived. He remained seated the entire time and said he felt week. A few minutes after EMS arrived, the patient left via stretcher by ambulance, but remained conscience.
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| 40 | 2021-06-07 | numbness |
40 year old male without any prior medical history, followed by PCP for yearly exams, who presents w...
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40 year old male without any prior medical history, followed by PCP for yearly exams, who presents with complaints of chest pain for the past few days. Pain is described as left sided chest discomfort, first associated with exertion as it started with walking 2 days ago, symptoms resolved when he got home. Again yesterday symptoms returned with walking but after symptoms improved but remained, described some numbness to left hand. He denies SOB, DOE and syncope. He does report palpitations. He was seen by PCP and underwent EKG which was unremarkable however symptoms continued so he came to ED for evaluation. EKG with ST elevations ECG: Sinus tachycardia:Otherwise normal ECG Normal sinus rhythm with sinus arrhythmia:ST elevation, consider early repolarization, pericarditis, He had a stress test and an echocardiogram which were reassuring (see results below). Pain/ discomfort had almost entirely dissipated. He was discharged home with NSAID.
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| 40 | 2021-06-08 | pain in extremity |
Pericarditis/ pericardial effusion- chest pain that radiated to arm. difficulty breathing in. went t...
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Pericarditis/ pericardial effusion- chest pain that radiated to arm. difficulty breathing in. went to ER and had CT scans to verify this diagnosis. Was treated with Ibuprofen and colchicine
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| 40 | 2021-06-10 | involuntary muscle movements |
Insomnia; Cough; his body start jerking; This is a spontaneous report received from a contactable co...
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Insomnia; Cough; his body start jerking; This is a spontaneous report received from a contactable consumer. A 40-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date was not reported) via an unspecified route of administration, on 03May2021 (at the age of 40 years) and second dose of BNT162B2 on 26May2021, as a single dose for COVID-19 immunization. The patient medical history included Ventricular tachycardia and concomitant medications included Amiodarone used for Ventricular tachycardia on an unknown date. Reporter stated that he took the highest dose in that medicine, yes the highest, I do not know what the highest is that he is taking I know it is the highest since they said they cannot give him anything now". Reporter stated, "My son might be having a reaction to the Pfizer vaccine and he has a test in the morning, but he already been into the emergency room and all these and I need to ask or talk to somebody that can medically give me some advice before his test specifically we do not know he can actually have this test now. Reporter added, "Now do you need to know his side effects that he is having from the vaccine that came from the vaccine. Okay the side effects he is having started right after his first vaccine on 03May2021 he started getting the sleep apnea well not sleep apnea sorry about that he started getting insomnia and he cannot sleep and he ended up getting a cough so when he went back to his second vaccine his insomnia started getting worse, he is like he cannot sleep at all and when he does fall asleep its only for 2 hours and he gets so tried, his body start jerking and makes him wake up. Report-er stated, "They are worsening". The patient underwent laboratory test and procedures which included chest X-ray, Nuclear test on Friday and have not got results for that test. Outcome of events was reported as unknown. Reporter seriousness for Insomnia, Cough, his body start jerking was unspecified.
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| 41 | 2020-12-31 | numbness, pain in extremity |
I have metal in my right shoulder, whole right arm went numb for half a day and was week. Metal in m...
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I have metal in my right shoulder, whole right arm went numb for half a day and was week. Metal in my left foot, whole left let=g is swollen and hurts, saw 3 doctors and they didn't know what to do, one doctor gave me Ibuprofen
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| 41 | 2021-01-01 | pain in extremity | Soreness and weakness of left arm for more than 5 days. Intermittent headaches and runny nose |
| 41 | 2021-01-02 | feeling cold, weakness |
My entire body felt really cold for the whole day on Tuesday. I couldn't get warm and had to put on ...
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My entire body felt really cold for the whole day on Tuesday. I couldn't get warm and had to put on extra clothing during the day and extra blankets when I went to sleep. I think this is considered to be chills. On both Tuesday and Wednesday, I ran out of energy by the afternoon. On both Tuesday and Wednesday, my head felt heavy.
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| 41 | 2021-01-04 | night sweats |
Fever of 101.0 F; chills with fever; fatigue; night sweats; This is a spontaneous report from a cont...
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Fever of 101.0 F; chills with fever; fatigue; night sweats; This is a spontaneous report from a contactable Nurse (patient). A 41-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EH9899), via an unspecified route of administration on 20Dec2020 15:00 at single dose for COVID-19 immunization. Vaccine location provided as Left arm. Medical history included Scleroderma, interstitial lung disease. There were no Known allergies to medications, food, or other products. Concomitant medication (reported as other medications the patient received within 2 weeks of vaccination) included ibuprofen, ergocalciferol (VITAMIN D), cetirizine hydrochloride (CITIRIZINE), famotidine. There were no other vaccines received within 4 weeks prior to the COVID vaccine. The patient did not diagnose with COVID-19 prior vaccination. The patient experienced Fever of 101.0 F, chills with fever, fatigue, night sweats on 21Dec2020 20:00. No treatment received for all reported events. The patient had Covid tested via Nasal Swab post vaccination with PCR result negative on 23Dec2020. The outcome of the events was recovered in Dec2020. This case was assessed as non-serious.
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| 41 | 2021-01-06 | weakness |
injection site pain, triedness, headache, muscles pain, chills, fever, joints pain feeling unwell, w...
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injection site pain, triedness, headache, muscles pain, chills, fever, joints pain feeling unwell, weakness.
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| 41 | 2021-01-06 | migraine | Headache migraine |
| 41 | 2021-01-07 | flushing |
1145 Patient received vaccine 1150 Patient reported feeling flushed and lightheaded. Denied shortnes...
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1145 Patient received vaccine 1150 Patient reported feeling flushed and lightheaded. Denied shortness of breath, difficulty breathing and hives. Patient instructed to lie down. Vital signs taken and within normal limits. Patient drank 4 oz of orange juice. After, patient reported feeling better. Observed patient for 15 minutes following episode. Patient denied any symptoms prior to leaving
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| 41 | 2021-01-08 | weakness, pain in extremity |
About 12 hours after admin; arm, shoulder, neck pain, progressed to generalized body aches, nausea, ...
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About 12 hours after admin; arm, shoulder, neck pain, progressed to generalized body aches, nausea, severe headaches, cough, mass weakness, diarrhea, joint pain. Symptoms started subsiding about 15 hours after onset. Minor cough still persist with minor shortness of breath.
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| 41 | 2021-01-08 | migraine | Headache migraine, red/sore, warm at site of injection,body aches |
| 41 | 2021-01-10 | hot flush, feeling cold |
Patient received first vaccine 12/29/2020. While in waiting period post-vaccination, he developed ti...
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Patient received first vaccine 12/29/2020. While in waiting period post-vaccination, he developed tinnitus and was hot, flushed, and diaphoretic. He felt very cold and "wobbly" after other symptoms subsided. He had sharp pains in the joints on the side of injection which continued through 1/1/21 later that day. He was tired and had a minor headache 12/29/2020-12/31/2020. Patient had a bout of severe depression and "not caring about anything" beginning 12/29/2020 and lasting about 16 hours. He has no history of depression. He awoke 1/1/2021 and the depression was gone. Patient states all these symptoms disappeared when his arm pain resolved. He developed a "strained" throat on 1/1/2021 which is the only symptom that has continued to the day of this report.
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| 41 | 2021-01-10 | migraine | 1. Lethargy 2. Intense Migraine 3. Joint pain 4. Foggy Brain 5. Heavy Chest 6. Chills |
| 41 | 2021-01-10 | pain in extremity |
Symptom: Headache | Treatment: Tylenol | Outcome: No resolution thus far; Symptom: Fatigue | Treatme...
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Symptom: Headache | Treatment: Tylenol | Outcome: No resolution thus far; Symptom: Fatigue | Treatment: Sleep | Outcome: Slight improvement in fatigue; Symptom: Left arm muscle soreness (same arm as injection) | Treatment: Tylenol | Outcome: No resolution thus far; and Symptom: Back pain (upper-left quadrant) | Treatment: Stretching and Tylenol | Outcome: No resolution thus far
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| 41 | 2021-01-11 | weakness | Lethargic not hungry Headache Weak Cloudy head |
| 41 | 2021-01-12 | weakness |
Nose is stuffy; Shortness of breath; Felt not really ok; itchy; Muscle soreness, like arms would fal...
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Nose is stuffy; Shortness of breath; Felt not really ok; itchy; Muscle soreness, like arms would fall off; Couldn't sleep; joint pain; had to miss work; fever reaching 104 degrees; chills; muscle ache; headache; tiredness; weakness; This is a spontaneous report from a contactable consumer (patient). This 41-year-old male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine) via an unspecified route of administration on at arm left 05Jan2021 at single dose (lot number: EK9231) for COVID-19 immunisation. Medical history and concomitant medications were unknown. The patient previously received flu vaccine and felt a little tired and sore with Flu vaccine. The patient got his first dose and then worked all day on 05Jan2021. Around 18:00-19:00 on 05Jan2021, he had fever, chills, muscle aches, headaches, joint pain, tiredness, and weakness. Fever was up to 104. The patient was referring to the Pfizer COVID-19 Vaccine first felt short of breath on 05Jan2021. He was wearing a mask and felt like he couldn't breathe. He did not feel really ok on 05Jan2021 like with a flu shot. He was working and felt a little itchy. He came home around 18:00-19:00 and had chills, headache, muscle soreness like arms would fall off. He couldn't sleep. He had fever and chills through the night. He had fever up to 104 on 05Jan2021 and had to miss work. The patient stated his nose was stuffy on an unspecified date. No additional vaccines administered on same date of pfizer suspect. No prior vaccinations within 4 weeks. Outcome of all events was unknown.
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| 41 | 2021-01-12 | pain in extremity, numbness |
2 days later I developed pain in my chest, back, lats, and entire arm. I have sharp numbing pain per...
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2 days later I developed pain in my chest, back, lats, and entire arm. I have sharp numbing pain periodically from my armpit to my pinky finger. This pain has only grown worse since onset despite my doctor prescribing oral steroids and pain meds. Painful to sneeze, cough and laugh
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| 41 | 2021-01-13 | weakness |
Fever 103.8 Perspiration Generalized fatigue and weakness Mild dyspnea without cough- now resolved....
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Fever 103.8 Perspiration Generalized fatigue and weakness Mild dyspnea without cough- now resolved. Soreness at injection site right arm.
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| 41 | 2021-01-13 | cold sweat | Slight fever, cold sweats, chills |
| 41 | 2021-01-13 | numbness, tingling |
Severe scapular pain that progressed to severe deltoid pain. and that developed to elbow pain over t...
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Severe scapular pain that progressed to severe deltoid pain. and that developed to elbow pain over the course of 3 days. Resulting in left index finger numbness and tingling. Still experiencing numbness and tingling and mild pain.
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| 41 | 2021-01-14 | tingling |
pins and needles throughout body. started 3 days post vaccination and continues 1 week after. had...
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pins and needles throughout body. started 3 days post vaccination and continues 1 week after. had low grade fever and fatigue in 24hrs post.
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| 41 | 2021-01-15 | pain in extremity |
The day after had myalgias and fatigue and arm pain. But on 1/10/21 began developing mild 2/10 head...
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The day after had myalgias and fatigue and arm pain. But on 1/10/21 began developing mild 2/10 headaches. On 1/11/21 the headache worsened to 4/10 and was associated with myalgias and neck stiffness. After a jog, I was in the shower and noticed a rash all over my body that had been pruritic. I went to the ER that night where I tested negative for flu A/B and also tested negative for covid (Antigen then PCR). Got a CMP, CBC, and coags to rule out ITP. everything was normal. The symptoms were so bad I stayed home from work on 1/12/21. Over the next few days the rash improved and the headache slowly went away
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| 41 | 2021-01-17 | tremor |
Patient received vaccine the day prior to my evaluation with him. He drank alcohol then had an episo...
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Patient received vaccine the day prior to my evaluation with him. He drank alcohol then had an episode where he fell, seemed to not be breathing normally, then had several episodes of tremors and shaking movements, though he was able to talk through these and did not have a postictal period. Concern for anxiety reaction or reaction to alcohol, but also feel could be related to vaccine.
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| 41 | 2021-01-18 | inability to speak |
1/16/21, Covid vaccine injection at 12:09 PM Minute 1: dizzy and light headed (like drinking a beer ...
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1/16/21, Covid vaccine injection at 12:09 PM Minute 1: dizzy and light headed (like drinking a beer on an empty stomach) Minute 10: Nausea Minutes 23-25: Neck tightness (like doing unsupported crunches and holding my head up) Minute 27: Inability to swallow and inability to speak EMS on site administered EpiPen auto-injection to left thigh, immediate improvement in symptoms Transport to hospital via ambulance Hospital monitored me for several hours and discharged same day
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| 41 | 2021-01-20 | feeling hot |
Within 30 min observation period post vaccine, Ten minutes after vaccine injection patient began fee...
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Within 30 min observation period post vaccine, Ten minutes after vaccine injection patient began feeling dizzy and hot. Monitor VS all within normal range. Gave water and allowed to lay and rest for full 30 min. Dizziness and hot feeling resolved discharged home @ 1234 with EC precautions.
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| 41 | 2021-01-24 | bell's palsy, tingling, facial paralysis | Bell's Palsy, right side facial droop, facial tingling, and feeling of facial fullness on 1/25/21. |
| 41 | 2021-01-26 | weakness |
Feeling weak; Muscle pain; Chills; Not been able to work for last 3-4 days; Please specify other loc...
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Feeling weak; Muscle pain; Chills; Not been able to work for last 3-4 days; Please specify other location: Right shoulder; Shortness of breath; Dizziness; This is a spontaneous report from a contactable consumer (patient). A 41-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EK9231, Expiry Date: 30Apr2021) via an unspecified route of administration in right shoulder on 30Dec2020 20:30 at single dose for COVID-19 immunisation. The medical history was not reported. There were no concomitant medications. The patient previously took influenza vaccine on 2020 for immunization 2-3 months before this BNT162B2 vaccine, previously took flu shot in the past for immunization and got sick from it. That was about 3 years ago (2018). The patient went and got the Pfizer BioNTech about 2 weeks ago. Wants to know if side effects can start then after the vaccine. He has had chills, muscle pain, shortness of breath, and dizziness. Got this at hospital and has not been able to go to work on Jan2021 that last 3-4 days due to feeling weak. Received the vaccine on 30Dec2020 and the dizziness and shortness of breath kind of started days after that on Dec2020. The chills started a couple of days ago, about 3 days ago (Jan2021) and has been off and on. The muscle pains started today (13Jan2021). Just got a text message about getting the second dose next Wednesday. He did not get any other vaccines that day or 4 weeks prior. He got the shot to protect himself from the virus, but feels like he has the virus or something. The events did not require a visit to emergency room, but may go to be seen tomorrow. Events outcome of chills, muscle pain, shortness of breath, dizziness, and not been able to go to work that last 3-4 days due to feeling weak was not recovered.
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| 41 | 2021-01-27 | bell's palsy |
Sudden onset right sided Bell's Palsy with tinnitus upon awakening in the morning. Proceeded to see...
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Sudden onset right sided Bell's Palsy with tinnitus upon awakening in the morning. Proceeded to see PCP in the afternoon where I was prescribed Prednisone 60mg/day x 7 days and Valacyclovir 500mg BID x 7 days.
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| 41 | 2021-01-27 | flushing | dizziness, sob, dry mouth, nausea, flushed, itchy jaw |
| 41 | 2021-01-28 | pain in extremity |
join pain initially in bilateral shoulders then within a few hours hurt all different areas around b...
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join pain initially in bilateral shoulders then within a few hours hurt all different areas around body especially in joints; Within first hour of injection slight nausea that lasted a few hours; pain in hands; This is a spontaneous report from a contactable healthcare professional. A 41-year-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EK5730), via an unspecified route of administration in the left arm on 28Dec2020 10:15 at a single dose for covid-19 immunisation. Medical history included food allergies to dairy and nuts. Concomitant medication was not reported. On 28Dec2020 11:00, the patient experienced slight nausea that lasted for few hours, along with join pain initially in bilateral shoulders then within a few hours hurt all different areas around body especially in joints. By end of day the patient could not type on phone due to pain in hands. Ongoing joint pain for almost three weeks now. The patient did not receive treatment for the events. The outcome of event nausea was recovered in Dec2020; all other events was not recovered.
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| 41 | 2021-01-28 | pain in extremity |
his eye felt irritated; swollen eye; red eye; Sore arm; This is a spontaneous report from a contacta...
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his eye felt irritated; swollen eye; red eye; Sore arm; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248, expiration date: Apr2021), via an unspecified route of administration in arm on 13Jan2021 02:00 at single dose for COVID-19 immunisation. Medical history included blood pressure (as reported). Concomitant medication included hydrochlorothiazide and lisinopril, both for blood pressure. The patient just took the vaccine on Wednesday (13Jan2021) and had a reaction, not sure if it was from the vaccine or not and he was just calling that in to report that as it can be related. The patient got vaccinated on Wednesday at 2 O' clock and no major issues, just sore arm. However, Friday (15Jan2021) afternoon he had woke from a nap and his eye felt irritated. He was still experiencing a swollen eye. So, he was calling about the swollen eye, red eye. He never had something like this before, didn't take anything that might cause it, the only thing unusual was because he got the vaccine. Treatment included using a cold compress only, not ingesting anything. The outcome of events sore arm, eye felt irritated and red eye was unknown, swollen eye was not recovered.
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| 41 | 2021-01-31 | weakness |
17h post the second dose of vaccination I have experience fever 38.1 C (100.6 F), persistent headac...
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17h post the second dose of vaccination I have experience fever 38.1 C (100.6 F), persistent headaches, chills, muscle pain, low energy and lost of appetite. Fever does not respond well with Tylenol (1000mg) and is persistent.
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| 41 | 2021-02-03 | cold sweat |
Syncopal event after shot given . Clammy and diaphoretic , ashen appearance and announced he was abo...
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Syncopal event after shot given . Clammy and diaphoretic , ashen appearance and announced he was about to pass out before he passed out . Has had between 15-20 similar episodes describable and recallable in his lifetime . Awoke after a brief 10 sec loss of consciousness. Felt immediately better and no different than any other episode that occurred after seeing needles and getting shots. Drank some water and dc home after observation . Drove himself home . No sequelae.
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| 41 | 2021-02-06 | night sweats, pain in extremity | Fever (101), night sweats, chills, sore arm |
| 41 | 2021-02-07 | facial paralysis |
Belly's palsy, right side of face; This is a spontaneous report from a contactable physician. This p...
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Belly's palsy, right side of face; This is a spontaneous report from a contactable physician. This physician reported for a 41-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Jan2021 at single dose for COVID-19 immunization. The patient medical history included anxiety, cervical myofascial pain syndrome, gastrooesophageal reflux disease (GERD), known allergies: eggs, detergent. The patient's concomitant medications were not reported. The patient previously took salbutamol (ALBUTEROL), diphenhydramine hydrochloride (BENADRYL), esomeprazole (NEXIUM), prochlorperazine (COMPAZINE) and experienced allergies. The patient experienced Belly's palsy, right side of face on 25Jan2021. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. Treatment received for the adverse event included prednisone and valaciclovir (VALACYCLOVIR). Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Outcome of the event was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the reasonable temporal association and lacking alternative explanations, the Company cannot completely exclude the possible causality between the reported Belly's palsy, right side of face and the administration of the COVID-19 vaccine, BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
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| 41 | 2021-02-07 | feeling hot |
Patient screened for first dose of Pfizer vaccine. He checked no history of allergies or reactions t...
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Patient screened for first dose of Pfizer vaccine. He checked no history of allergies or reactions to medications or vaccines. In the initial screening he informed me he had a phobia of needles but this is usually with blood draws. He reported he should be fine with vaccinations. I inquired on previous reactions and he denied any allergic reaction just that he does not like them. I asked him how I can help give the vaccine. We had him look away and to think of a different situation. I asked him if he would like to know when I am administering or just use distraction. He chose to be informed when he would feel a slight poke. Vaccine was administered with no issues. Within the minute following the vaccine patient started to feel dizzy. Hung his head a bit but was responsive. I requested staff assistance to help the situation including RN to prevent any episodes of syncope. We provided water which he was able to drink. He was still seated and we suggested putting head between legs. This was not comfortable for him so we moved him to the floor. About 3-4 min in he began to sweat a bit more and appeared Pale. We obtained a BP and pulse. BP was 112/60 and pulse around 60. When he felt hot, sweaty and appeared pale we all decided to call EMS to be cautious. He maintained BP, no SOB, did not lose conscious. EMS evaluated him, med list provided and vitals. He was on medications for anxiety. They released him after about 30min and reported a panic attack and not related to the vaccine. Patient walked out of the clinic with his partner and was stable. He is requesting 2nd dose of the vaccine. I informed him nurse would review and would have a plan for future injection.
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| 41 | 2021-02-07 | pain in extremity |
Shooting pain down left arm, Swollen Lymph node in neck, slight fever, hand pain between ring and m...
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Shooting pain down left arm, Swollen Lymph node in neck, slight fever, hand pain between ring and middle fingers, Tylenol , appointment with PCP
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| 41 | 2021-02-09 | facial paralysis, numbness, bell's palsy |
Bells Palsy DX on 2/9/2021 Started feeling right sided facial numbness on 2/8/2021 at 4:00 pm. Then ...
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Bells Palsy DX on 2/9/2021 Started feeling right sided facial numbness on 2/8/2021 at 4:00 pm. Then noticed slight right eye droop.
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| 41 | 2021-02-10 | discomfort, tremor, feeling of body temperature change |
Within our injection shot sore. No other adverse effects until 5:00 a.m. Woke up because body was ve...
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Within our injection shot sore. No other adverse effects until 5:00 a.m. Woke up because body was very hot similar to being in a sauna. Removing for changing the blanket to a thinner one resulted in extreme chills within one minute. Covering with blanket resulted in extreme hot within 10 minutes. Repeated this cycle for several hours until fall asleep. High discomfort throughout body. Woke up at 10:00 a.m. with mild grade fever of 99.5° (average resting temperature is 96.5). Felt extreme cold and chills shivering body aches headache until 6:00 p.m. felt hungry and okay enough to eat. Main concern is the extreme hot to extreme cold cycle in early morning. It felt as though the body was not in sync. During fever throughout day/afternoon body's reaction was normal - fever meant chills and shivering, putting on a blanket meant comfortable warmth (after long periods of time). But in early morning no no fever yet body burning hot almost suffocating sauna heat insider body, and removing the blanket a immediate and severe chills with uncontrollable shaking, instead of relief from heat... Concerned if vaccine affects body's heart regulation system (hypothalamus, thyroid, etc). General malaise during this period is an understatement... It was not a single spot or feeling pain it was the whole body wanting to twist itself and feeling 'deprssed' and very 'ill' all over all at once.
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| 41 | 2021-02-11 | numbness | Again fatigue and just feels awful but also leg numbness which is new. |
| 41 | 2021-02-12 | unresponsive to stimuli, pain in extremity | Swollen leg/pain- taken to urgent care- became unresponsive - CPR initiated- expired |
| 41 | 2021-02-14 | pain in extremity |
Chills; Body aches; Barely able to move his arm; He feels horrible/not feeling well; He can't sleep;...
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Chills; Body aches; Barely able to move his arm; He feels horrible/not feeling well; He can't sleep; Ringing in the ears; Nausea; Flu like symptoms; Bad sore arm; Muscle aches; Joint pain; This is a spontaneous report from a contactable consumer (mother of the patient). The same consumer reported information for 3 patients. This is the first of 3 reports. A 41-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 25Jan2021 at single dose for COVID-19 immunisation at the age of 41-year-old. Medical history and concomitant medications were unknown. On 25Jan2021, the patient experienced Flu like symptoms, He had a bad sore arm, barely able to move his arm, Nausea, Muscle ache, Joint pain; no fever. On unknown date, the patient experienced not feeling well/ feels horrible, chills, body ache. Patient stayed home from work one day. On 27Jan2021, the patient felt a little better, but he still would have the symptoms. On 28Jan2021, the patient had ringing in the ears, he has muscle aches, he could not sleep. Patient reportedly as very well young man and he has no medical problems. The patient was recovering from the events. Information about lot/batch number has been requested.
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| 41 | 2021-02-16 | muscle spasms |
The initial symptoms exp stomach cramping. Then on 12/31 I started exp pain in lower back felt like...
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The initial symptoms exp stomach cramping. Then on 12/31 I started exp pain in lower back felt like muscle spasm. I went to ER got Chest Xray,Flu (results negative)and Covid test (result positive).
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| 41 | 2021-02-18 | grand mal seizure |
Tonic clonic seizure; This is a spontaneous report from a contactable physician. A 41-year-old male ...
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Tonic clonic seizure; This is a spontaneous report from a contactable physician. A 41-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown), via an unspecified route of administration on 01Feb2021 14:00 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced tonic clonic seizure on 01Feb2021, the same day. The patient received the dose at 14:00 and had the seizure around 19:00. Patient has recovered from the event on an unspecified date. No treatment was received for the event. Information about lot/batch number has been requested.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported tonic clonic seizure and the administration of the COVID-19 vaccine, BNT162B2, based on the reasonable temporal association and lacking alternative explanations. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
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| 41 | 2021-02-18 | night sweats |
Initial adverse events: night sweats, fever, body aches, muscle aches (Back pain). These all occurr...
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Initial adverse events: night sweats, fever, body aches, muscle aches (Back pain). These all occurred about 12 hours after the second shot and subsided around 36 hours after the second shot. 8.5 days after the second shot I had throat and chest pain. This pain then continued and got worse to the point I went to the ER and was evaluated for potential heart attack. After testing - results were that I did not have a heart attack. I was still experiencing this pain, so the ER took a strep test. This was also negative. The diagnosis was "pulled chest muscle". I've had pulled muscles, I know what those feel like and it sure didn't feel like what I experienced on the night of the 16th and the day of the 17th of Feb. 2021.
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| 41 | 2021-02-19 | flushing |
Flushing/sweating, right-sided warmth (right arm at injection site). Patient has a history of anxiet...
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Flushing/sweating, right-sided warmth (right arm at injection site). Patient has a history of anxiety and hypertension. Initial BP 161/102 (pulse 102); final BP 132/88 (pulse 95).
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| 41 | 2021-02-21 | unresponsive to stimuli |
Patients spouse reports he started to feel "funny" 5 mins post vaccination administration. Patients ...
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Patients spouse reports he started to feel "funny" 5 mins post vaccination administration. Patients spouse called for assist when he he became unconscious at 7:25pm. He was found unconscious and failed to respond to a sternal rub. EMS called. Initial assessment: HR-weak pulse-not palpable, agonal, shallow breathing, and unresponsive. VS- BP 160/100 HR- 100 Wife used smelling salt to arouse the patient. He was confused after regaining consciousness. 7:37pm- EMS arrived and assumed care, transferring patient to a higher level of care.
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| 41 | 2021-02-22 | muscle spasms | Nausea, vomiting, cramping, fever, chills, lethargy, headaches, and body aches |
| 41 | 2021-02-24 | weakness |
Full body aches all night long, then fever of a 102.3 followed by chills, also headaches, feeling of...
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Full body aches all night long, then fever of a 102.3 followed by chills, also headaches, feeling of low energy
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| 41 | 2021-02-24 | migraine |
Persistent migraine not responsive to medication with onset approximately 48 hours after vaccine and...
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Persistent migraine not responsive to medication with onset approximately 48 hours after vaccine and proceeding to this report. I am a sufferer of migraines, but this is especially intense and persistent.
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| 41 | 2021-03-03 | tingling, pain in extremity |
Burning pain immediately after injection. Pain and redness has persisted. Pain in the left arm rad...
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Burning pain immediately after injection. Pain and redness has persisted. Pain in the left arm radiating down the arm in the elbow, forearm, and wrist. Tingling sensation in the pinky and ring finger. Burning pain and ache in the left arm. Feeling of burning and cold felt in the arm.
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| 41 | 2021-03-05 | tingling |
I have shingle like skin rash on my neck for more than 13 days. it is itching all over my body and ...
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I have shingle like skin rash on my neck for more than 13 days. it is itching all over my body and tingling kind of pain on my neck and back. I have been using 10% benzoyl peroxide but not getting improvements. I am planning to go to dermatologist next week.
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| 41 | 2021-03-09 | numbness, face paralysis |
He received first dose of Pfizer COVID vaccine 1/15. Next day, he felt right axilla and trunk numbne...
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He received first dose of Pfizer COVID vaccine 1/15. Next day, he felt right axilla and trunk numbness after that which lasted 2-3 weeks and was resolving. After the second dose early Feb 5th, he started having difficulty swallowing and SOB and felt a little better after a course of steroids and antibiotics but got a lot worse after finishing the course and presented to ED 2/16 and was found to have supraglottic edema requiring intubation and treatment with IV steroids. Was extubated on 2/19, in ICU until 2/21. He did well with treatment and was discharged 2/22. Patient received a dose of influenza vaccine (FLULAVAL - GSK lot: 7N43B) on 2/22/21 3/2 he started having burning pain in the right midthoracic area, the next day he noticed right hand weakness/numbness (4th and 5th digits), gradually progressed. 3/4 noticed right facial weakness, initially was lower face, Unable to drink without drooling. MRI brain was done 3/5 and was normal. 3/5 facial weakness progressed to upper face. Unable to close right eye for the last 24 hrs. He also reports numbness left 5th digit. Presented to the ED on 3/6. Found to have elevated transaminase in ED. Hospitalization continues at this time. Etiology of symptoms is unknow, but includes vaccine reaction, shingles or early stages of autoimmune disease.
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| 41 | 2021-03-10 | weakness, numbness |
Dizziness, numbness of left arm and leg, along with weakness. BP 150/95, pulse 78, O2 sat 99%. Given...
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Dizziness, numbness of left arm and leg, along with weakness. BP 150/95, pulse 78, O2 sat 99%. Given juice, water and crackers. Rested.
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| 41 | 2021-03-10 | tingling, pain in extremity |
Tingling/itching sensation over right side of face and scalp, starting approximately 10 minutes afte...
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Tingling/itching sensation over right side of face and scalp, starting approximately 10 minutes after vaccination and lasting approximately 20 minutes. Resolved without treatment Intermittent, then sustained muscle soreness in the right arm starting approximately 6 hours after vaccination and lasting until approximately 48 hours after. Resolved without treatment. Fatigue the day following vaccination, and the day following that, but not on the day of vaccination. Resolved without treatment.
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| 41 | 2021-03-11 | flushing |
20 minutes of monitored and recorded tachycardia (peak heart rate of 188) while at rest. Accompanied...
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20 minutes of monitored and recorded tachycardia (peak heart rate of 188) while at rest. Accompanied with perspiration, flushing, myalgia and malaise. Tachycardia resolved, other symptoms persisted for 12+ hours.
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| 41 | 2021-03-14 | pain in extremity |
Fever, Pain (Mostly My legs), Cough, Shortness of breath, and Phlegm. took Tylenol Severe Cold and F...
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Fever, Pain (Mostly My legs), Cough, Shortness of breath, and Phlegm. took Tylenol Severe Cold and Flue and Claritin - D 12 hrs. Lasted 24 hr. Started Saturday Night and ended Monday Morning. Feeling exhausted after the events.
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| 41 | 2021-03-15 | tremor |
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: LEFT ARM TREMERS-Mil...
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Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: LEFT ARM TREMERS-Mild, Systemic: Nausea-Mild
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| 41 | 2021-03-16 | tingling |
Tingling in ears and extremities, heart was racing, tickle in throat, dizzy, short of breath, nauseo...
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Tingling in ears and extremities, heart was racing, tickle in throat, dizzy, short of breath, nauseous
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| 41 | 2021-03-17 | migraine |
Swelling at injection site and swelling of hands. Next day migraine, vertigo and rash on right leg. ...
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Swelling at injection site and swelling of hands. Next day migraine, vertigo and rash on right leg. The vertigo has consisted and the rash has spread throughout my whole right leg and now on my left leg.
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| 41 | 2021-03-18 | burning sensation |
Sunburn like feeling starting on stomach, forearms and but cheeks. Head pain on left side Sunburn li...
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Sunburn like feeling starting on stomach, forearms and but cheeks. Head pain on left side Sunburn like feeling now in armpits and neck pain running down thru back
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| 41 | 2021-03-18 | pain in extremity |
For the first 24 hours I had no symptoms other than arm pain. For the next 6 days experienced debili...
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For the first 24 hours I had no symptoms other than arm pain. For the next 6 days experienced debilitating headaches, which led to nausea (because they were so severe). Elevated blood pressure also coupled with headaches. I initially took Ibuprofen (which helped somewhat), whereas Tylenol did nothing. I also have a flexible ice pack that I placed over my head. That also helped a little. I went to the doctor on March 17th, but he was dismissive of the headaches being related to the vaccine. I have since been referred to a neurologist (April 1st appointment).
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| 41 | 2021-03-22 | pain in extremity |
Headache, nausea, fever, chills, soreness in right arm, and insomnia. No treatment provided. Symptom...
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Headache, nausea, fever, chills, soreness in right arm, and insomnia. No treatment provided. Symptoms ongoing as of 9:45am 03/23/2021
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| 41 | 2021-03-23 | feeling cold, numbness |
The patient is a 41 yo male with a history of seasonal allergic rhinitis who experienced DVT and PE ...
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The patient is a 41 yo male with a history of seasonal allergic rhinitis who experienced DVT and PE temporally related to Pfizer BioNTech COVID vaccine dose #2 receipt. He is a Service Member and reported high levels of baseline activity, including running 10 miles each Saturday. He received vaccine #1 25 JAN 21 (EN5318) without AE. He received dose #2 on 16 FEB 21, (EN6200). He experienced no immediate symptoms suggestive of IgE event. On day 1 he reports feeling cold, mild fatigue but no other symptoms. On day 2 he was baseline. On day 3 he noted numbness, tightness and discomfort to his right calf. On day 4 (Saturday), his usual long run day, he experienced dyspnea and lightheadedness after running 20-30 feet. He states he noted tightness in his calf and instead walked the track while his wife completed her run. He rested day 5. Day 6 he noted significant edema to his calf, which he describes as double normal in size, and iced it. Day 7, he tried to schedule with PCP and based on triage was sent to ER. ER diagnosed R DVT and bilateral PE's. He was admitted overnight, started anticoagulation therapy. He saw hematology, and the workup was negative for other causes.
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| 41 | 2021-03-23 | pain in extremity, feeling hot |
woke up warm/sweaty; mild general body aches/stiffness; Mild arm soreness; trouble sleeping; This is...
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woke up warm/sweaty; mild general body aches/stiffness; Mild arm soreness; trouble sleeping; This is a spontaneous report from a contactable healthcare professional (patient). This 41-year-old male patient received dose 2 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE) via an unspecified route on 18Feb2021 at 09:15 (at the age of 41-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included psoriasis for which he received guselkumab (TREMFYA) injections every 2 months. The patient had not received any other vaccines within 4 weeks prior to the vaccine. The patient had not been diagnosed with COVID-19 prior to the vaccine. The patient did not receive any concomitant medications. The patient did not have any allergies to medications, food, or other products. The patient previously received dose 1 of BNT162B2 on 27Jan2021 at 01:30 as a single dose in the right arm for COVID-19. On 19Feb2021 at 00:00 after dose 2 of BNT162B2 the patient experienced mild arm soreness, woke up warm/sweaty, had trouble sleeping, and mild general body aches/stiffness. The events were reported as non-serious. The patient was not hospitalized for the events. The patient did not receive any treatment for the events. The outcomes of mid arm soreness, woke up warm/sweaty, had trouble sleeping, and mild general body aches/stiffness were recovered. It was also reported that since the vaccine the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
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| 41 | 2021-03-23 | pain in extremity |
Soreness in arm, started about 1/2 hrs lost injection, lasted about 24 hours. Headache, started abou...
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Soreness in arm, started about 1/2 hrs lost injection, lasted about 24 hours. Headache, started about 6/7 hrs post injection. Increased in severity the next day. Non-issue as of 3/24
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| 41 | 2021-03-23 | pain in extremity | Persistent sore arm for over a month now |
| 41 | 2021-03-24 | cold sweat | felt heart was racing, comes and goes. clammy hands, anxious. HR 92 BP 136/82 |
| 41 | 2021-03-24 | muscle twitching, tingling, numbness, burning sensation |
Numbness and tingling in feet and hands. Burning sensation all over body and muscle twitching all o...
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Numbness and tingling in feet and hands. Burning sensation all over body and muscle twitching all over body. Roof of mouth burning. Tingling on lips and tongue. Bruising and gum bleeding.
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| 41 | 2021-03-28 | numbness | Mild body aches, mild headaches, numbness and tingling down the arm injected, little light headed |
| 41 | 2021-03-28 | muscle spasms, feeling hot, pain in extremity | Dull pain in calf, cramping legs , tired , warm sensation |
| 41 | 2021-03-29 | discomfort |
I felt fine at first for the 15 minutes they held me for observation. But as I walked out to my car ...
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I felt fine at first for the 15 minutes they held me for observation. But as I walked out to my car I quickly got heavy and tired and started to ache and have a headache. I had to rest in my car for a while before driving home. Once home I crashed immediately for around 4 hours in the middle of the day which is not like me. I had an important dinner meeting i had to attend for my livelihood. I thought I was feeling better but half way through Dinner I started feeling bad again. Got to the point that I stopped eating and excused myself to get home and rest. Symptoms progressed rapidly. Unfortunately I was pulled over for a minor traffic stop and tried to explain that I was having a bad reaction to the vaccine and needed to get home. They wouldn?t believe me and torturously treated me like an OVI. I?m hoping that I can get some kind of documentation and or assistance. I have court on the 1st and it will be devastating if I am convicted. I was not intoxicated and was not warned about the dangers of driving after the vaccine. Please call me. I need help
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| 41 | 2021-03-30 | weakness |
Low grade fever (100.9); Tiredness; headaches; muscle pain; chills; joint pain; nasal congestion; Di...
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Low grade fever (100.9); Tiredness; headaches; muscle pain; chills; joint pain; nasal congestion; Dizziness/Weakness; Dizziness/Weakness; This is a spontaneous report from a contactable consumer (patient). A 41-years-old male patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), via an unspecified route of administration, administered in Arm Left on 29Jan2021 14:00 (Batch/Lot Number: EL1283) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The reporter stated that since Saturday at 10AM. Low grade fever (100.9). Tiredness, headaches, muscle pain, chills, joint pain, nasal congestion, Dizziness/Weakness. Scale of 1-10, 10 being the worst= Level 9 on 30Jan2021 at 10:00 AM. The patient not received treatment for the events. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The report considered as a non serious. The outcome of the events was reported as not recovered.
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| 41 | 2021-03-31 | cold sweat |
NAUSEATED, BLACKED OUT, COLD SWEAT. CAME TO FINE WITHIN A FEW SECONDS EPISODE RESOLVED QUICKLY CLIEN...
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NAUSEATED, BLACKED OUT, COLD SWEAT. CAME TO FINE WITHIN A FEW SECONDS EPISODE RESOLVED QUICKLY CLIENT MONITORED FOR 30 MINUTES AND LEFT WITHOUT FURTHER INCIDENT.
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| 41 | 2021-03-31 | pain in extremity |
Aches in my arms and shoulders began a few days before the second vaccination in the series. After ...
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Aches in my arms and shoulders began a few days before the second vaccination in the series. After receiving the second vaccination, the aches progressed to full upper body aches. They have since progressed to full body aches. I also had major chills 2 nights ago.
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| 41 | 2021-03-31 | tingling |
Patient is 41 years old, male. Alert, oriented X3, clear speech, able to answer to the questions. Un...
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Patient is 41 years old, male. Alert, oriented X3, clear speech, able to answer to the questions. Underlying medical conditions include Down Syndrome, high cholesterol, and asthma. History of allergic reaction to bethanechol ? swelling, no anaphylactic shock. Denied having allergies to food, other vaccines, or components of COVID-19 vaccine. Patient was tested positive for COVID- 19 in December 2020, was hospitalized for 11 days but was not admitted to ICU or intubated. At 11:50 am, patient received first dose of Pfizer, lot number EW0150, expired on 07/2021 on right deltoid, given by RN. At 12:08, while waiting in observation area, patient reported of tingling and swelling in right hand. EMTs and RN responded. Vial signs were taken every 5 minutes. At 12:08, BP 121/82, Sp02 at 95% room air, HR 110bpm; skin was warm to touch, normal skin color on face and lower extremities. At 12:13 pm, BP 123/82 sitting, HR 107 bpm, 2+, RR 22 res/minute, unlabored, patient was moved to anti-gravity chair. Per sister, patient hasn?t eaten anything this morning. Water and cookies were offered, patient ingested 250 ml and 100% of cookies, patient stated ?I?m feeling a lot better, no more tingling?. Upon assessment, noted significant decreased swelling on right hand, normal skin color, capillary refill <3s bilaterally. At 12:24 pm, BP 121/80, SpO2 92%, RR 20 res/min, unlabored, no acute distress noted. At 12: 28, BP 121/79, HR 104, strong, RR 20 res/min, unlabored, SpO2 95%. At 12:34 pm, BP 121/78, SpO2 95%, HR 102 bpm, RR 20 res/min, unlabored, patient ingested 250 ml of water, denied any discomfort. Patient?s education was provided to patient and his sister, they verbalized understanding. At 12:45 pm, patient left facility, he was accompanied by family members and EMT to their car. Patient was able to walk without assistance, gait was balance.
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| 41 | 2021-04-01 | burning sensation |
I EXPERIENCED A BURNING SENSATION AFTER URINATION FOR THE REMAINDER OF THE DAY YESTERDAY, AFTER I RE...
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I EXPERIENCED A BURNING SENSATION AFTER URINATION FOR THE REMAINDER OF THE DAY YESTERDAY, AFTER I RECEIVED THE VACCINE.. I URINATED THIS MORNING AND THE SENSATION WENT AWAY.
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| 41 | 2021-04-01 | discomfort |
Within 5 mins of the shot, I got dizzy but I sat down and that feeling went over. After dinner the s...
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Within 5 mins of the shot, I got dizzy but I sat down and that feeling went over. After dinner the same day, I had vertigo and had to vomit. Since then there has been nausea and headache, and I have trouble sleeping in. I feel some more discomfort after eating food. I have intermittent fever also. It has been about 10 days today since I got my COVID Pfizer shot and I still don't feel physically well. I just wanted to report this, as the impression from documentation I read is that symptoms should go away in 3-4 days.
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| 41 | 2021-04-01 | tingling |
Tingling in feet and lower calf muscle a few hours after injection. Some calf swelling and light thr...
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Tingling in feet and lower calf muscle a few hours after injection. Some calf swelling and light throbbing two days later, continued tingling in feet (pins and needles) now on day 4 after injection and unresolved. Tingling increases after physical activity. Swelling has subsided on day 4. Treated only with rest, compression socks, and keep legs raised when possible, so far. Some swelling of the lymph nodes in groin area.
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| 41 | 2021-04-02 | pain in extremity |
Dose 1: Severe headache for the next day, minor pain and moderate stiffness of R arm over the next 2...
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Dose 1: Severe headache for the next day, minor pain and moderate stiffness of R arm over the next 24 hours. I am *not* submitting this report for the first dose. Dose 2: Moderate headache over next day, mild fatigue over next day, moderate joint pain over next day, same discomfort/stiffness of R arm. The one thing I wanted to report was my L shoulder. I had pulled/torn it around Wednesday of the week and it hurt quite a bit when I put it in the wrong position, but it was otherwise fine. However, post-second Pfizer shot, the pain in my L shoulder easily double or tripped for some reason as a reaction to the vaccine. Basically, Friday before the shot, my should hurt a little bit but had been getting progressively better. But post-second Pfizer shot, the same area that had mild pain before now felt like I had been stabbed in the shoulder or that I had re-torn the muscle and had done so in a significantly worse way. It's not a big thing, but you may want to start asking people if they've recently had any muscle injuries prior to vaccination. I'm now ~30 hours post vaccine and it is decreasing in pain, but the shot obviously had some type of impact on what bruising/swelling/tearing of my L shoulder that I had. (Note that both vaccine shots were to the R arm and the L should was not related to that in any way.)
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| 41 | 2021-04-03 | cold sweat, feeling cold |
6pm April 2 - began feeling nauseous and chilled, began shivering. 8pm April 2 - began vomiting...bo...
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6pm April 2 - began feeling nauseous and chilled, began shivering. 8pm April 2 - began vomiting...bouts of vomiting every 1.5 hours from 8 pm April 2 until 12 noon on April 3. An acute stomach ache followed and continued until the morning of April 4th. After vomiting stopped, I laid in bed from about 3pm on April 3 until 9 am on the 4th...I would sleep for 45 minutes at a time and wake in a cold sweat...I physically felt very cold, but was drenched in sweat. The chills and cold sweats stopped on the morning of the 4th and gave way to a lingering but persistent headache and dull stomach ache which are continuing now (3pm on April 4), but seem to be slowly fading.
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| 41 | 2021-04-03 | pain in extremity |
Aches in the lower back and legs.; Aches in the lower back and legs.; This is a spontaneous report f...
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Aches in the lower back and legs.; Aches in the lower back and legs.; This is a spontaneous report from a contactable consumer or other non hcp. A 41-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number: EL3247, Expiration date unknown), via an unspecified route of administration, anatomical location arm left on 12Feb2021 09:15, at single dose for Covid-19 immunization. The patient Medical history included hyperaldosteronism. concomitant medication included omeprazole (PROTONIX [OMEPRAZOLE]), spironolactone (ALDACTONE [SPIRONOLACTONE]), amlodipine besilate (NORVASC), nebivolol hydrochloride (BYSTOLIC). Historic vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number: EL3247, Expiration date unknown), via an unspecified route of administration, anatomical location Left arm on 23-JAN-2021 09:00 AM, at single dose for Covid-19 immunization. on 12Feb2021 at 14:00 patient experienced aches in the lower back and legs. The patient did not receive any treatment for the event The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient has not tested for COVID-19. The outcome of event was recovering.
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| 41 | 2021-04-04 | bell's palsy | Bell's palsy on right side of my face. |
| 41 | 2021-04-04 | numbness |
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Numbness (specify: facial area, extremiti...
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Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: Patient experienced numbness in arm a few minutes following COVID vaccine. He was instructed by the pharmacist to sit for 30 minutes for monitoring instead of the usual 15 minutes. After about 30 minutes, he said he was experiencing difficulty breathing (he was alert and orientated and was able to talk but he said he was laboring to breathe). EMS was called. No treatment was given on site by EMS and the patient elected to be brought to the hosptial.
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| 41 | 2021-04-06 | weakness | Extreme fatigue, extreme weakness, extreme soreness. |
| 41 | 2021-04-07 | feeling hot |
Patient reported he started feeling hot, dizzy, nauseous, lightheaded and faint within a few minutes...
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Patient reported he started feeling hot, dizzy, nauseous, lightheaded and faint within a few minutes of receiving the vaccine. We sat him down and grabbed our nurse practitioner. She monitored his pulse. He began to feel so faint that he asked to lay on the floor. We called 911. When paramedics arrived he was starting to feel much better. By the time it was over he left the store (was not transported to the hospital).
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| 41 | 2021-04-07 | numbness |
Starting 12 hours after dose: Rotating between fever and chills Fever of 103+ Numbness / loss of fee...
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Starting 12 hours after dose: Rotating between fever and chills Fever of 103+ Numbness / loss of feeling in tips of fingers / thumb Tinnitus Lower back pain Lack of focus / irritable Overall random shots of pain through body Diarrhea legs and feet turned purple Constant frontal headache Lack of appetite/ nausea Some foods taste metallic
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| 41 | 2021-04-08 | weakness | Headache, stiffness, body aches, diarrhea, heartburn, fever 101.4 , feel extremely weak!!! |
| 41 | 2021-04-08 | cold sweat | Woke up with cold sweat, nausea and vomiting, fatigue. |
| 41 | 2021-04-08 | feeling cold, tremor |
patient felt chilled through out body immediately after receiving vaccine with full body shaking sho...
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patient felt chilled through out body immediately after receiving vaccine with full body shaking showed signs of low blood sugar but said he did eat lunch he was unsure of what medications or insulins doses that he had taken today. gave sugar and water and no improvement symptoms progressed oover 10 minutes patient developed ragged breathing 911 was called and epi pen administered. was taken to hospital by ems.
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| 41 | 2021-04-08 | flushing |
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Flushed / Sweating-Mild,...
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Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Lymph Node Swelling-Mild, Additional Details: patient felt like his throat was itchy and felt flushed and sweating. he had no other apparent symptoms, we gave him a benadryl and he appeared to be fine
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| 41 | 2021-04-09 | cold sweat |
Patient reported feeling clammy, lightheaded, short of breath, anxious, and nauseated after vaccinat...
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Patient reported feeling clammy, lightheaded, short of breath, anxious, and nauseated after vaccination Patient seen by medical team and vitals improved after patient drank Gatorade Patient reported not having anything to eat in the morning Patient has history of anxiety Patient refused medical transport and signed medical form, patient stated symptoms improved Patient will have a family member pick him and his daughter up to drive home
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| 41 | 2021-04-10 | cold sweat |
on 4/11/2021 approximately 1pm , just left home from lunch and went back to work. started having c...
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on 4/11/2021 approximately 1pm , just left home from lunch and went back to work. started having chest tightness, chest pain, called wife -- he felt clammy and all around not feeling well and above symptoms. Advised him to come home- stayed on phone with him til he arrived home. took his blood pressure with wrist bp machine while sitting at dining table and it was 171/85 and pulse was 85 so called EMS.
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| 41 | 2021-04-10 | tenderness, night sweats |
Severe muscle aches and joint pain; shakes and chills; intense night sweats; and large mass under le...
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Severe muscle aches and joint pain; shakes and chills; intense night sweats; and large mass under left arm (injection arm). All started the morning after the second dose, and lasted until the following morning. The mass in my armpit is still present and is slightly sore to the touch.
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| 41 | 2021-04-11 | seizure |
I immediately past out twice and was told I had two minor seizures. I declined ambulance and have fe...
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I immediately past out twice and was told I had two minor seizures. I declined ambulance and have felt dizzy spells since. I have appointments to get checked out.
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| 41 | 2021-04-12 | numbness, tingling |
Shingles. The day after the second dose of my Pfizer vaccine I felt numbness and tingling on the le...
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Shingles. The day after the second dose of my Pfizer vaccine I felt numbness and tingling on the left side of my body. Specifically on the left side of my left arm and down through the left pinky finger. I also had the same sensation/numbness down the left side of my left leg and into my left pinky toe. The sensation is intermittent and typically on the left side (the same side of the body as the injection). Two weeks later I began to feel more tingling on the left side including up through my left jaw and on the left side of the top of my head. The following day I realized I had two blisters under my left arm pit which made it clear I had shingles. Today is 3 weeks since my second shot and I still continue to feel numbness and tingling.
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| 41 | 2021-04-12 | tremor, feeling hot |
pt began feeling "hot" nad was sweating moments after reviewing vaccine. Vitals BP 161/97, HR 110, ...
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pt began feeling "hot" nad was sweating moments after reviewing vaccine. Vitals BP 161/97, HR 110, O2 sat 99%. Pt's entire body began shaking. Pt was unable to walk. EMS called, transported to hospital.
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| 41 | 2021-04-13 | pain in extremity | Soreness in arm for first 2-3 days Fatigue for 1 week so far, still ongoing |
| 41 | 2021-04-15 | feeling cold | Cold chills, sore body and muscles, debilitating headache. |
| 41 | 2021-04-15 | one side paralysis |
Transverse myelitis presenting with Urinary retention and hyperreflexia as well as left sided weakne...
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Transverse myelitis presenting with Urinary retention and hyperreflexia as well as left sided weakness. Treated with high dose steroids
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| 41 | 2021-04-16 | pain in extremity, muscle spasms |
Vaccine on the 6th Sore arm that day. That night before bed dizzy, tired, back muscles tightenin...
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Vaccine on the 6th Sore arm that day. That night before bed dizzy, tired, back muscles tightening. 7th. Dizzy , tight muscles, sore arm, that late afternoon i sneezed. My back went out. Severe spasms and pain from The 7th-16th. Late night on the 16th. Chest neck and shoulder pain. Heart flutters, tachycardia, oxygen levels dropping to 89. Hovering around 95. Severe nausea. Abdomen pain. Tight painful muscles in legs Same and worse today on the 17th , had ER visit Been taking Valium and Tylenol for pain and spasms per my PCP since April 15
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| 41 | 2021-04-17 | weakness |
Sleep for a few minutes, I didn't pass out but it was similar; Was pulled over "for minor traffic v...
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Sleep for a few minutes, I didn't pass out but it was similar; Was pulled over "for minor traffic violation." He was told "to get out of the car and had a field sobriety test, and I looked intoxicated."; Felt heavy and tired/Run down; Had a headache; Upset stomach; sleep for a few minutes, I didn't pass out but it was similar/crashed for 4-5 hours in the middle of the day which I never do; aching; Over all weakness; Started feeling sick again at dinner; Woke up feeling really bad; Bad diarrhea; This is a spontaneous report from a contactable consumer or other non hcp. A 41-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 25Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. Medical history included drug hypersensitivity from an unknown date and unknown if ongoing Allergic to sulfa, PCN and amoxicillin. The patients concomitant medications were not reported. On an unspecified date the patient experienced sleep for a few minutes, I didnt pass out but it was similar, was pulled over for minor traffic violation. He was told to get out of the car and had a field sobriety test, and I looked intoxicated, felt heavy and tired/run down, had a headache, bad diarrhea, upset stomach, sleep for a few minutes, I didnt pass out but it was similar, crashed for 4 to 5 hours in the middle of the day which I never do, aching, overall weakness, started feeling sick again at dinner, he went to the bathroom a few times, woke up feeling really bad. The patient was worried because everything was coming to a head right now. The caller got the first shot, he waited for 15 minutes and felt fine. As the caller walked to his car he began feeling heavy, had severe diarrhea, headache, aching, it was almost like he passed out, it felt like he went to sleep. The patient got home and crashed 4 to 5 hours in the middle of the day and woke up feeling really bad. The patient went to a very important dinner meeting that night. While the patient was at the meeting he went to the bathroom a few times and then excused himself because he felt so bad. The patient did not even finish one cocktail with dinner. The caller got pulled over for a minor traffic stop, cutting the corner and crossing the line or something small. The officers believed the caller was driving under the influence and started making him do a sobriety test with 40 degree wind gusts, the patient was miserable. The caller told the officers that he needed to seek medical attention but they ignored him. The officers forced the caller to do the urine test. It has been 5 days since his vaccination and he is just now feeling better. The outcome of events was recovering. No follow-up attempts are needed. No further information is expected.
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| 41 | 2021-04-17 | weakness |
Covid test result Positive; Covid test result Positive; Steadily increasing headache; Muscle ache; w...
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Covid test result Positive; Covid test result Positive; Steadily increasing headache; Muscle ache; weakness; feverish; This is a spontaneous report from a contactable consumer. A 41-year-old male patient received BNT162b2 (PFIZER- BIONTECH COVID-19 mRNA VACCCINE; Lot Number: UNKNOWN- reported as misplace/discarded), dose 1 via an unspecified route of administration, administered in left arm (at the age of 40 years) on 21Dec2020 at 12:15 (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. There was no patient medical history. The patient had no known allergies to medications, food, or other products. There were no concomitant medications (no medications within 2 weeks prior to vaccination). The patient did not received any other vaccine within 4 weeks prior to the COVID-19 vaccine. On 21Dec2020 at 14:30, 2.5 hours after the vaccine, the patient had steadily increasing headache, muscle ache, weakness and feverish. He took 250mg Tylenol. At 5.5 hours after the vaccine, his headache was so severe that he went to the Emergency Department of the facility he works in. Treatment for the adverse event included 1gram Tylenol, IV with saline and another drug (unspecified). The patient did not have COVID-19 prior to vaccination. On 24Mar2021, post vaccination, he was tested for COVID-19 via nasal swab with a positive result. The outcome of headache, muscle ache, weakness and feverish was recovered. The outcome of COVID-19 was unknown. The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.
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| 41 | 2021-04-17 | pain in extremity |
Sore arm starting 12 hours after shot Body aches, chills, fatigue, headache starting 26 hours after ...
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Sore arm starting 12 hours after shot Body aches, chills, fatigue, headache starting 26 hours after shot and lasting for 6 to 8 hours
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| 41 | 2021-04-17 | paralysis |
complete body went paralyzed; lost vision; throwing up; fever; This is a spontaneous report from a c...
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complete body went paralyzed; lost vision; throwing up; fever; This is a spontaneous report from a contactable consumer. A 41-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: En6207), dose 1 via an unspecified route of administration, administered in left arm on 23Mar2021 08:30 as single dose for covid-19 immunisation. Medical history was reported as none. There were no concomitant medications. The patient started throwing up, fever, complete body went paralyzed and lost vision all it the ER on 05Apr2021 13:00. The events were resulted in emergency room /department or urgent care. There is some treatment (saline and ondansetron) for the events. The patient did not have covid prior vaccination, did not test covid post vaccination. The patient received Covid test post vaccination via Nasal Swab on 05Apr2021, covid test result was negative. There is no known allergies, no other medical history, no other vaccine in four week, no other medications in two weeks. The outcome of the events was resloving.
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| 41 | 2021-04-18 | hot flush |
Metal taste in mouth within 30 minutes of injection., similar to injection 1. I otherwise felt fin...
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Metal taste in mouth within 30 minutes of injection., similar to injection 1. I otherwise felt fine and had a normal day of moderate physical activity. I awoke in the middle of the night with chills and body aches and a strong feeling of anxiety. I was able to fall back asleep and woke up as normal a few hours later. I had a very strong head ache centered behind my sinuses, body aches in my pelvis and legs, and hot flashes mixed with chills. Aches were manageable with Tylenol. As the day progressed those continued and I was very fatigued. I went to bed earlier than normal and after a full night's sleep symptoms subsided.
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| 41 | 2021-04-18 | migraine |
Starting after leaving pharmacy (receiving second vaccination), sunlight sensitivity causing migrain...
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Starting after leaving pharmacy (receiving second vaccination), sunlight sensitivity causing migraine like headaches and nausea. Symptoms are lessened with sunglasses. Onset is within minutes of being in direct or overcast sunlight. Symptoms have persisted for 8 consecutive days since vaccine.
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| 41 | 2021-04-18 | unresponsive to stimuli | Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium |
| 41 | 2021-04-19 | weakness, pain in extremity |
A few hours after my 2nd shot I got dizzy then a headache. My arm hurt too, quite a bit. The next mo...
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A few hours after my 2nd shot I got dizzy then a headache. My arm hurt too, quite a bit. The next morning I woke up with a fever of 101.5 and kept that fever for 2 more days. I felt weak, dizzy, but the physical pain was the worst. My head was pounding, my neck, back, and legs all hurt. That passed after a day except the headache. 3 days later I still have a low fever, headache, but mostly dizziness. I've never been seriously ill in my life. Ive never been sick enough to get antibiotics prescribed. I eat healthy, don't drink or smoke. This vaccine floored me though. Like getting run over by a truck.
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| 41 | 2021-04-19 | bell's palsy | Bell Pasly on left side of face. |
| 41 | 2021-04-19 | seizure |
Patient had an episode with convulsions and loss of consciousness lasting a couple seconds after eat...
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Patient had an episode with convulsions and loss of consciousness lasting a couple seconds after eating a marijuana edible.
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| 41 | 2021-04-20 | feeling hot |
Pt was vaccinated with Pfizer-BioNTech COVID-19 vaccine EUA and told the vaccinating nurse that he "...
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Pt was vaccinated with Pfizer-BioNTech COVID-19 vaccine EUA and told the vaccinating nurse that he "always faints around needles." Pt was vaccinated and moved to post-vac area; he then began complaining of feeling "sweaty and hot." Pt chose to lie on the floor. Pt's vitals were within normal limits. Pt denied any chest pain, SOB, or other discomfort. Pt lied on the floor for approximately 15 minutes and then stated that he was feeling better. Pt was able to stand without assistance or dizziness and ambulate with a steady gait. Pt left clinic in care of his wife and stated that he felt "back to normal." Pt was advised to seek medical assistance if he began experiencing the same feelings again.
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| 41 | 2021-04-20 | flushing |
Patient had received his 2nd dose of Pfizer vaccine at 1020. After about 5-7 minutes he started to ...
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Patient had received his 2nd dose of Pfizer vaccine at 1020. After about 5-7 minutes he started to feel "flush". He spoke with medical personnel onsite and it was explained that reactions like that are common. Was advised to remain onsite for further observation. Approximately 10 minutes later PT started to feel a tingling in his lips, face and a little on his tongue. Medic on site administered 0.5ml of liquid antihistamine, and was advised to wait another 10 minutes for more observation. After next block of time PT stated that he "felt well enough to leave and was comfortable with everything" PT left site at 1108
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| 41 | 2021-04-21 | bell's palsy | Bell Palsy |
| 41 | 2021-04-21 | burning sensation | Headache, fatigue, sore muscles, lungs burning, fever, cough and I was all ways hungry |
| 41 | 2021-04-21 | tingling |
Tingling towards extremity (distal) left arm. BPs 149/86 (pulse 96), 147/88 (pulse 89). O2 sat 99%-1...
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Tingling towards extremity (distal) left arm. BPs 149/86 (pulse 96), 147/88 (pulse 89). O2 sat 99%-100%.
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| 41 | 2021-04-22 | feeling hot |
Approximately 5 minutes after injection, pt began complaining of "feeling warm." He was provided wit...
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Approximately 5 minutes after injection, pt began complaining of "feeling warm." He was provided with water by a staff member. The patient then fell to the floor from a seated position in a chair in the observation area. The EMT and Paramedic immediately responded to the patient. They assessed the patient and brought him into a wheelchair once he was feeling well enough to do so. The patient never lost consciousness. Initial vitals: BP 96/60, O2 95% on room air, RR 24, HR 64. The Paramedic took a 12-lead EKG, result was Sinus rhythm with apparent ST elevation. Subsequent EKG was sinus brady with apparent ST elevation. The patient was free of contusions or scrapes from his fall from the chair. PT initially refused transportation to the emergency department. After some convincing, the patient was agreeable to seek elevated medical treatment and was transported by ambulance.
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| 41 | 2021-04-22 | feeling hot |
About 10 minutes after receiving the vaccine. I felt hot and sick to my stomach. I couldn't breathe....
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About 10 minutes after receiving the vaccine. I felt hot and sick to my stomach. I couldn't breathe. I took my mask off and fanned myself. I started to feel dizzy and then I fell to the floor and passed out. The paramedics did an ekg and thought I was having a heart attack. They rushed me to the Emergency Room and they performed more tests. The tests showed their was nothing wrong with my heart previously.
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| 41 | 2021-04-22 | muscle twitching |
Eye twitching in left eye - never had one since birth, started on the day following the shot. Occurs...
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Eye twitching in left eye - never had one since birth, started on the day following the shot. Occurs a few times a day. Not impacting day to day life. Headache - lasted for 5 days.
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| 41 | 2021-04-22 | tingling |
Patient states he was sitting when he got very hot and nauseated before fainting. Staff saw patient ...
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Patient states he was sitting when he got very hot and nauseated before fainting. Staff saw patient fall to carpeted floor face first and ran to his side. Patient briefly non-responsive but almost immediately regained consciousness and turned over onto his back. Legs elevated to chair and patient instructed to remain supine. Vitals at 1:35pm 120/80, HR 91%, O2 level 97%. Patient states he tends to get very hot and nauseated with shots. 1:37 pm: c/o tingling in both hands and requested an ice pack. Obtained his wife's phone number and contacted her using his phone. Attempted to cleanse abrasions to (L) forehead and bridge of nose but he was not able to tolerate the smell. Drinking bottled water provided by staff. EMS enroute. 1:40 EMS arrived; BP 112/72, HR 89, O2 98%. Patient remains alert and oriented. Kept supine. Using his ice packs to hands. 1:57pm: Still has tingling and slightly nauseated. EMS requested privacy with patient.
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| 41 | 2021-04-23 | pain in extremity |
Sore arm, whole body muscle soreness, dizziness, fatigue, chills. Symptoms started 6 hours after va...
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Sore arm, whole body muscle soreness, dizziness, fatigue, chills. Symptoms started 6 hours after vaccine shot and lasted 2 days.
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| 41 | 2021-04-24 | inability to speak |
I developed full anaphylaxis within 30 minutes of receiving my Covid-19 vaccine.; dizziness; nausea;...
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I developed full anaphylaxis within 30 minutes of receiving my Covid-19 vaccine.; dizziness; nausea; inability to swallow; mouth going dry; unable to speak; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 16Jan2021 12:00 (Lot Number: el3248) as single dose (at the age of 41-years-old) for covid-19 immunisation. Medical history included Heart disease, hyperlipidaemia, hypertension, pituitary adenoma. It was reported that patient received concomitant medications in two weeks prior to the vaccination, no details reported. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. Patient stated that he developed full anaphylaxis within 30 minutes of receiving his Covid-19 vaccine on 16Jan2021 (Adverse event start time reported as 12:00 P.M.). It started with dizziness, then nausea, then inability to swallow and mouth going dry, finally unable to speak. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). Patient was treated for the events with epinephrine (EPIPEN) on site by emergency medical services (EMS) and transport to hospital. The patient was not diagnosed with COVID-19 prior to vaccination and had been tested for COVID-19 post vaccination. The patient underwent laboratory tests and procedures which included sars-cov-2 test (Nasal Swab) negative on 11Feb2021. Patient had no known allergies other than the Covid-19 vaccine. Patient recovered from the events on unknown date.
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| 41 | 2021-04-24 | weakness |
collapsed; weak/weakness; muscle pain; Confusion; Fatigue; Shortness of breath; This is a spontaneou...
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collapsed; weak/weakness; muscle pain; Confusion; Fatigue; Shortness of breath; This is a spontaneous report from a contactable physician. A 41-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown) via an unspecified route of administration on 04Apr2021 at a single dose for covid-19 immunization. Medical history included G72.3 periodic paralysis. Concomitant medication included diclofenamide (KEVEYIS) taken for an unspecified indication, start and stop date were not reported. It was unknown if the patient received other vaccines within four weeks. It was unknown if the patient had covid prior vaccination. The physician stated that the patient received the Pfizer vaccine on Sunday 04Apr2021. The patient collapsed about an hour and half later and, has felt very weak and was experiencing muscle pain since then - all experienced on 04Apr2021. The patient has also been experiencing weakness, confusion, fatigue, and shortness of breath all since Sunday 04Apr2021. The physician reported that there were two different kinds of potassium in the vaccine which he felt was contributing to this. It was informed that the patient has been currently resting and will follow-up if his symptoms don't improve. The outcome of the adverse events was unknown. It was unknown if treatment was received for the adverse events. It was unknown if the patient was tested for covid post-vaccination. Information on the lot/batch number has been requested.; Sender's Comments: Based on available information and temporal relationship, a possible contributory role between BNT162B2 vaccine and the reported events can not be excluded. Case will be re-assessed upon the additional information provided. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 41 | 2021-04-24 | numbness, tingling |
Ive been diagnosed with ADEM by findings from a MRI inflammation of cervical spine and brain , symp...
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Ive been diagnosed with ADEM by findings from a MRI inflammation of cervical spine and brain , symptoms began around a week after 2nd shot and got worse for about a month , pain in neck ,tingling though body , headaches, sunburn feeling in torso , fatigue , bilateral numbness in hands, loss of bladder pressure, erectile dysfunction
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| 41 | 2021-04-24 | night sweats, burning sensation |
Day 1: Symptom a) Severe Abdominal and Back Muscle pain for two to three hours before taking acetami...
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Day 1: Symptom a) Severe Abdominal and Back Muscle pain for two to three hours before taking acetaminophen. Pain consisted of sharp pain wrapped around my torso. Symptom b) Nausea. Symptom c) Tiredness Day 2: Mild chills in the evening and night sweats Day 3: Mild chills in the evening and night sweats Day 4: Abdominal and Back pain for approximately one hour (pain reduced after taking acetaminophen. Pain continued overnight. Day 5: Tiredness Day 6: Felt great Day 7: Severe Abdominal and back pain wrapped around my torso and burning sensation in my back
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| 41 | 2021-04-25 | burning sensation, pain in extremity |
My husband it was for his second dose of the vaccine, bit at the next day at the morning got a kin...
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My husband it was for his second dose of the vaccine, bit at the next day at the morning got a kind of burn like a water pump which at first there were some in that area but the next day it became a big pump like water inside, today, Monday, April 26, that pump woke up. and it has been like when you have a burn you have not had a fever only muscle pain in your arm, and have taken tylenol
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| 41 | 2021-04-25 | numbness | Numbeness started in LUA, traveled up to skull to chin/cheek feeing like a Novocain shot |
| 41 | 2021-04-26 | bell's palsy |
Dr., reports that pt experience Bells Palsy 12 days post-vaccination. Dr., reported that pt went to ...
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Dr., reports that pt experience Bells Palsy 12 days post-vaccination. Dr., reported that pt went to Hospital on 4/17/2021 and released same day; pt was prescribed Medrol dose Pak and Acyclovir. Pt was seen by Dr., (general practitioner & ophthalmologist), Dr., discontinued the Medrol dose Pak and Acyclovir and prescribed Prednisone 60/40 to be taken for a week and Valtrex 1 mg to be taken TID x7 days; Dr., also ordered protein spikes for IgM and IgG Herpes Zoster & Herpes Simplex, basic blood test. Pt have follow up appt today with Dr., since pt is starting to develop dry eyes and he cannot close his eyes, pt is prescribed artificial tears drop for use during the day and CELLUVISC eye ointment to used during the night. Dr., recommends that pt refrained from getting the 2nd dose until more is known based on pt.'s condition; from his professional experience Bell's Palsy can dissipate in 4-6 months and not uncommon after post flu vaccination. Advised Dr. per CDC Bell's palsy is not a contraindication to getting 2nd dose of the vaccine. Advised we agreed with his recommendations that pt should postpone his second dose to see if his symptoms dissipate first. 4/21-Spoke to Dr. and he had concerns of patient receiving second vaccination shot. I advised currently per CDC there are no contraindications with vaccine and Bell's Palsy. Recommended for him to contact CDC hotline for further advice and transferred his call to CDC Covid hotline. Dx with Bell's Palsy; feeling more movement on the face today. Working with Dr. in regards to treatment and second dose of Pfizer vaccine. Will contact next week to follow up.
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| 41 | 2021-04-27 | involuntary muscle movements, tremor, tingling, muscle twitching, one side paralysis, weakness |
3/26 @ 3:15pm ? Got the first dose of Pfizer COVID-19 vaccine for the 1:10pm appointment. However ac...
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3/26 @ 3:15pm ? Got the first dose of Pfizer COVID-19 vaccine for the 1:10pm appointment. However actual time received was around 3:15pm. No vaccine reaction was observed and drove back home. However did not eat or drink much from morning till 4:30pm due to the long line at the vaccination center 4/4 @ 9:00pm ? Experienced first sign of near-syncope at the dinner table upon picking up a glass of milk 4/6 @ 8:45am ? Experienced brain fog, to be exact head felt like it was filled with cotton candy, at the back and top of the head. Felt this way the entire day. Went to work as usual. Logged out at around 5:30pm 4/7 @ 9:00am ? dizziness started getting worse. Started feeling imbalance and started losing depth perception which climbing down staircase 4/8 @ 10:00am ? started to get easily startled by any unexpected trigger. Whole body would ?twitch? or ?startle? upon slightest unexpected event. For e.g., sound, touch, taste (hot/cold) 4/10 @ 12:00pm ? Went to ER. ER ordered series of book tests, EKG, chest x-ray. Everything came out normal. ER doctor said to wait it out and after a week symptom may go away. ER doctor felt body?s immune response was over-working due to the vaccine immune response and possibly pollen allergy I may have experienced right after getting the vaccine. No prescription meds give. Advised to take Meclizine 25mg and Zyrtec. Below are the symptoms experienced on 4/10: ? Lightheadedness/Sudden Jerking body movements when triggered/passing out momentarily for a second when taking strain/not in my elements ? Feeling extremely fatigued. Did not sleep well at night on 4/8 and 4/9 ? Head feels Intoxicated, foggy, lightheaded, as if stuffed with cotton candy. Startled when unexpected things happen like a sudden jerking movement along with momentary passing out while anything unexpected happens. E.g., when I am pushing myself on the sofa to re-position, I feel my whole body is turning off for a second. Simply does not feel normal ? Rubbery legs ? Worsens after shower. I feel like I need to lay down as the foggy feeling worsens after shower ? Lightheadedness. Losing control sometimes. ? I am easily startled when climbing down the stairs - no Depth perception. ? Don?t have the strength to blow nose or cough. Feels like momentary fainting when doing these activities ? Dis-equilibrium. Whole body is twitching when something unexpected happens to my senses. ? Unable to control while laughing feels like momentary faint. I have felt like this when I was down with a fever. Tickled easily ? Difficulty pulling myself out of bed. Felt like muscle was giving away ? Tingling feeling in the right abdomen area ? Difficulty staying alert or focused and random rather unpleasant thoughts constantly coming to mind. Felt a bit of panic attack. 4/11 ? Went to PCP. Body weakness and fatigue got worse. PCP did blood sugar test and flushed out the left ear. Ordered Brain MRI to see if structurally anything was wrong. Brain MRI came out OK as well however noticed minor sinusitis. Prescribed Amoxicillin antibiotics and nasal spray. Referred me to Neurologist and Head and Neck Specialist. 4/11 ? 4/15 - Above symptoms progressively got worse. Especially weakness in the arms and shoulders. Arms quivered every time trying to stand up and felt like fainting. Hand-eye coordination progressively got worse. For e.g., could not pick up water bottle, hands were quivering badly 4/15 ? Neurologist conducted certain diagnostic tests and concluded that there are no neurological issues. Said with rest and plenty of fluids it should get better. Spinal tap was not recommended and said if symptoms got worse a spinal tap can be done during the next visit. Follow up visit with neurologist scheduled on 4/27 4/15 ? 4/27 ? Weakness in arms got better. Arm strength and coordination has improved however it?s still not back to normal. Brain fog and dizziness still persists with no improvement. Left limb and arms are stronger than the left. Difficulty climbing up and down stairs. Dizziness worsens after shower. Not feeling myself. In addition, not able to multitask - getting startled and need to be deliberate about having to do everyday chores need to just focus on one task 100% completely and if something else comes up then my body just goes into a momentary shock. Mostly I can feel my head feeling heavy and my eyelids shutting down when something shocking happens ? a feeling like body is ?turning off?, almost a fainting or passing out feeling. Sometimes when I turn to one side and sleep, I can feel a flickering sensation in the ear. Still always feeling woozy and as if there is something in my head ? a medicated or intoxicated feeling in the head 4/27 ? Neurologist said she sees a lot of improvement and reiterated again that I don?t have any neurological issues. She said I can go back to work starting 5/1. She said I may have Conversion Disorder / Disequilibrium. It?s hard for me to fathom why she would diagnose me with Conversion Disorder when so many people are reporting very similar symptoms that I am facing on the below forum: https://www.drugdiscoverytrends.com/dizziness-among-common-covid-19-vaccine-side-effects/ 4/30 ? Next appointment with Head and Neck / Audiology
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| 41 | 2021-04-28 | bell's palsy, facial paralysis |
Patient developed right facial paralysis and no other symptoms on 4/4/21, pt. was given an injection...
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Patient developed right facial paralysis and no other symptoms on 4/4/21, pt. was given an injection of Solumedrol 125 mg IM. Patient was seen in clinic on 4/5/21 and diagnosed with Bell's Palsy and treated with high dose of prednisone 60 mg with a 13 day taper. Patient was seen again on 4/13/21 with a slight improvement of symptoms. High dose steroids was extended for another 13 day taper. Patient was seen again on 4/29/21, with symptoms about the same as last appointment. Patient will be given some ibuprofen, no real benefit for more steroids at this time. Patient will continue to have follow ups. It has been less than a month since first symptoms were reported, and may take up to 6 months for symptoms to resolve.
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| 41 | 2021-04-29 | flushing | Patient had nausea, flushing and sweats approximately 5 minutes after vaccination |
| 41 | 2021-04-29 | tremor, feeling cold |
Felt extremely tired around 7:30pm. Went to bed. Woke up at 6:00am to get kids ready for school, fel...
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Felt extremely tired around 7:30pm. Went to bed. Woke up at 6:00am to get kids ready for school, felt intense headache joint pain, and intense cold feeling to the point of shaking. Went to bed again around 7:45 am. Slept most of the day with headache getting worse. Next day symptoms lessened slightly still bad headache and brain fog which I still have as of today but getting better.
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| 41 | 2021-05-04 | weakness, tremor |
Woke up at 0700 drenched in sweat with chills. Slight fever of 99.7F . Started my work day from home...
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Woke up at 0700 drenched in sweat with chills. Slight fever of 99.7F . Started my work day from home with a meeting at 0900 and knew by 0920 that I had to take the day off. Spent the entire rest of the day and night in bed. Fever peaked at 101.1F , nausea, constant headache, shaking chills and then sweats, extreme fatigue and full body severe muscle soreness. Light headed and very weak. I slept all day until almost 1500. When I woke up my fever was gone. I'm left tonight feeling hungry again along with some residual sore muscles and aches. The fever responded well to Ibuprofen. I hydrated with water and Gatorade. It pretty much felt like influenza for just under 48 hours. I feel like I'm past the worst of it now, but I'm not fully recovered.
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| 41 | 2021-05-09 | pain in extremity |
On April 18 and 19, following my 2nd injection, I had very bad chills and could not get warm. I was ...
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On April 18 and 19, following my 2nd injection, I had very bad chills and could not get warm. I was nauseous although I did not vomit. On April 22, I began having severe sharp stabbing pains just to the right of my belly button. It felt like I was being stabbed with a very hot knife, and after about 15-90 seconds, it would go away. Anytime I reached for something, bent over, twisted, turned or tried to hug someone, I would get this same pain and it would double me over in pain. On Monday April 26 at 7pm, I finally checked into the Emergency Room at the direction of my Primary Doctor. They did a bunch of blood work on me and sent me for a CT Scan of my abdomen. All of the blood work came back in normal ranges, and the CT Scan showed my appendix was "borderline" according to the surgeon. They consulted with Dr and decided to admit me for a surgical consult and further examination. They gave me fluids and morphine through an IV for the first 24 - 36 hrs, and then switched to Norco by mouth. I continued having pain throughout my stay. On Thursday, April 29, they took me to surgery for "exploratory surgery" with the intention of removing my appendix and looking around to see if anything else stood out to them that would cause me this pain. They stated my appendix had scar tissue on it and they removed it, but said they did not know if this would stop the pain I was having. On Friday April 30, I was released from the hospital at approximately 6pm. By 9pm on Friday, I began having those same sharp, stabbing, burning pains in my abdomen again, now to the right of my belly button again and further towards my right side. I also had sharp burning pain in the inside of my upper right arm, between my bicep and tricep muscles. This pain continued on through the weekend occurring more frequently and more severe. On Monday morning at about 1:30am, I woke up with severe abdominal pains all over and went into the bathroom. I had diarrhea and nausea and felt like I was going to vomit. Between 1:30am and 7:30am, I went to the bathroom 6 times. I went to work on Monday and continued having abdominal pains and diarrhea all day and night. On Tuesday, I went to the bathroom a total of 17 times. On Wednesday, I saw my primary Dr., who examined my abdomen and pains. He suggested I take immodium for the diarrhea and a supplement for muscle pain, as he felt this was the cause of my pain. On Wednesday, I went to the bathroom 21 times and was very nauseaus. I started the Imodium and it had no effect on me whatsoever. On Thursday, I had to call off work because I couldn't stop using the bathroom. By 4pm, I had been to the bathroom 18 times. I returned to the ER. They took a stool sample and did an ultrasound in the ER. They decided to admit me again for surgical consult and pain management. On Friday, Dr ordered another ultrasound of my abdomen, specifically my gallbladder, kidney, and liver. He also sent me for a CT Scan with contrast. They completed a total lab workup of my blood. All of these results came back normal, and nothing on the images showed anything wrong with my organs. On Saturday May 8, Dr came to the hospital to examine me. He stated everything related to my GI was fine. He asked if I have back pain, which I told him I do. At this time, I was in extreme pain and I couldn't even touch my skin. Dr attempted to examine my abdomen, and just by placing his hand on my stomach, I screamed in pain. He then put his hand behind my back and pushed a little, and it cause extreme pain in my abdomen. At this time, Dr suggested that maybe the pain is caused by something going on in my back. Maybe a pinched nerve or something. He ordered an X-ray of my upper and lower spine. Later that day, the results of the X-ray came back and showed there was nothing wrong with my spine. With these results, Dr then ordered an MRI of my lumbar and thoracic spine. On Sunday May 9 at 1030am, I was taken to radiology for an MRI. The initial report shows that I do not have any pinched nerves and nothing notable that would cause this type of pain in my body. As of now, no diagnosis or explanation for the pain I am experiencing. The pain is gradually getting worse and at times I am unable to move at all without extreme severe pain in my body. At times, my right groin hurts and I am unable to stand on my feet, as it feels as if I have pulled a groin muscle. The pain in my abdomen takes my breath away and feels like I am being set on fire in that area of my body. The pain no longer goes away and is constant, but moves throughout my right side from my groin to my shoulder only. I am not able to put my right arm behind my back because I get this pain in the back of my shoulder area. This pain is only on my right side at this time. So far, there is no explanation for this pain. I never had anything like this until I got the vaccine.
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| 41 | 2021-05-10 | bell's palsy | Bells palsy, complete, right sided |
| 41 | 2021-05-14 | pain in extremity |
a potential false blood pressure readings/The readings were over 200/140/took it on his wrist and me...
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a potential false blood pressure readings/The readings were over 200/140/took it on his wrist and measured at 215/147; the pain at the location of the lower arm got near tremble; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 28Apr2021 16:00 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included blood pressure abnormal, blood cholesterol abnormal, deafness. The patient's concomitant medications included unspecified products received within 2 weeks of vaccination. The patient previously received the first dose of BNT162B2 on 06Apr2021 01:15 PM at arm left for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination, he has not been tested for COVID-19. The patient reported a potential false blood pressure readings on 29Apr2021, a day after administered 2nd dose. The readings were over 200/140 and he took it at home using a blood pressure reading device. He took it on his wrist and measured at 215/147. In his recent doctors visit prior to administer the 2nd dose, the accurate readings was 183/136 (estimated). With the false blood pressure readings, the pain at the location of the lower arm got near tremble due to the fact of the false readings has been taken. The events outcome was unknown. Information on the Lot/Batch number has been requested.
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| 41 | 2021-05-19 | facial paralysis |
temporary facial paralysis; This is a spontaneous report from a non-contactable consumer (patient). ...
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temporary facial paralysis; This is a spontaneous report from a non-contactable consumer (patient). A 41-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on 30Apr2021 14:00 (Batch/Lot number was not reported) (at the age of 41 years old) as unknown (dose number), single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. No other vaccine in four weeks. On 02May2021, the patient experienced temporary facial paralysis. There was no treatment for the event. No COVID prior vaccination and patient had not been tested for COVID post vaccination. The outcome of the event was recovered on unspecified date. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 41 | 2021-05-23 | numbness, tingling, muscle spasms |
Since my 2nd dose of my Covid shot, I experienced an inflamed lymph node in my left armpit. It laste...
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Since my 2nd dose of my Covid shot, I experienced an inflamed lymph node in my left armpit. It lasted about a week and eventually passed. But since that event, I have been experiencing sharp pains on the left side of my body (arms, legs, buttocks), such as shocks, tingling, and numbness in my extremities. If I lift my left arm up, I get the sensation the arm and hand is falling alseep. But it's not the normal falling asleep sensation, more of a shocking pain running to my hands. My buttocks/back thigh area is constantly cramping up.
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| 41 | 2021-05-23 | migraine, pain in extremity |
Sever chills, headache, extreme fatigue, sore arm, worse migraine ever suffered and never had a migr...
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Sever chills, headache, extreme fatigue, sore arm, worse migraine ever suffered and never had a migraine before, nausea, exhaustion. All of these lasted 48 hours and the migraine did not occur until 72 hours later.
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| 41 | 2021-05-23 | seizure |
~15-30 mins post vaccine dose, patient developed seizure and transferred to outside hospital emergen...
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~15-30 mins post vaccine dose, patient developed seizure and transferred to outside hospital emergency room via ambulance. Unknown if patient admitted.
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| 41 | 2021-05-24 | tingling |
Patient complains of itching and tingling. Benadryl was given patient stated feeling better and lef...
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Patient complains of itching and tingling. Benadryl was given patient stated feeling better and left.
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| 41 | 2021-05-26 | cold sweat, feeling cold |
Got LURRY, DIZZY, COOL, CLAMMY- legs raised, icepack applied to neck, apple juice and crackers give...
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Got LURRY, DIZZY, COOL, CLAMMY- legs raised, icepack applied to neck, apple juice and crackers given, fan air patient felt better, patient mentioned not eating much earlier today
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| 41 | 2021-05-26 | migraine |
Labile BP; Rapid heart rate; Migraines; Body aches; Chest pain and tightness; Chest pain and tightne...
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Labile BP; Rapid heart rate; Migraines; Body aches; Chest pain and tightness; Chest pain and tightness; Inflammation; This is a spontaneous report from a contactable other hcp (parent). A 41-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), dose 1 intramuscular, administered in right arm on 22Dec2020 15:00 as 1st dose, single for covid-19 immunisation. Medical history included covid-19. The patient's concomitant medications were not reported. There is no other vaccine in four weeks. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19, covid test type post vaccination was Nasal Swab on 29Dec2020, covid test result was negative. Starting 5 days post vaccine (26Dec2020 18:00), ongoing symptoms of labile BP; rapid heart rate; migraines; body aches; chest pain and tightness; inflammation. Now going on 6 months of ongoing issues that have resulted in 4 ED visits, multiple tests and numerous doctor's office visits. There is some treatment (Medication) for AE. The adverse event result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The outcome of the events was resolving.; Sender's Comments: Based on known safety profile it is unlikely that the reported events were causally related to bnt162b2. These are probably intercurrent medical conditions. Case will be reassessed if additional information is received. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Committees and Investigators, as appropriate.
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| 41 | 2021-05-26 | nerve pain |
nerve pain from his ulnar nerve to his elbow and his hand and it came around to his chest, and his c...
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nerve pain from his ulnar nerve to his elbow and his hand and it came around to his chest, and his chest was on fire and his abdomen and his hip and foot; arm at the injection site was sore; Neck stiff; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 41-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9262; Expiration Date: 31May2021), dose 1 via an unspecified route of administration, administered in Arm Left on 07Feb2021 (at the age of 41-years-old) as SINGLE DOSE for covid-19 immunisation. Medical history and concomitant medications was not reported. The reporter said the first day he didn't feel anything. The caller states that on the second day after getting the vaccine, arm at the injection site was sore and neck stiff on 08Feb2021. Caller states that the Tuesday after his vaccine, he was fine most of the day but in the afternoon the patient experienced nerve pain from his ulnar nerve to his elbow and his hand and it came around to his chest, and his chest was on fire and his abdomen and his hip and foot on 09Feb2021. Caller woke up the next day with no pain, but his left arm was weak. Caller states that the day after that, everything seemed fine except whenever he uses his left arm, the triceps and armpit still hurt. Caller was scheduled for his second dose this coming Sunday, and he was wondering what the recommendations are for getting the second dose with having had symptoms like this following the first dose. Caller reported that the pain to the injection site on his left arm has resolved but he is still having nerve pain in his left arm. It was stated that nerve pain that right now it did not hurt, but if he were to use his arm, and do labor, that was when the nerve pain flare ups. Caller states that when he was resting it was good, but when he uses his arm, it flares up. Caller states the nerve pain was persisting, because it was not worse, but it was not going away. The patient underwent lab tests and procedures which included blood test: everything was good on Nov2020 everything was good. Outcome of the event (nerve pain from his ulnar nerve to his elbow and his hand and it came around to his chest, and his chest was on fire and his abdomen and his hip and foot) was not recovered, arm at the injection site was sore was recovered on an unspecified date and neck stiff was recovered on 10Feb2021. Follow-up attempts completed. No further information expected.
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| 41 | 2021-05-28 | weakness |
had diarrhea; a fever of 103*F; He was shivering due to lack of energy; He was shivering due to lack...
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had diarrhea; a fever of 103*F; He was shivering due to lack of energy; He was shivering due to lack of energy; lost his voice; threw up; sleeping for 48 hours; terrible pain in his stomach which made him scream to the point where he lost his voice; metallic taste in the mouth; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm left on 23Apr2021 14:15 (Batch/Lot Number: EW0171, not sure if the 0 is a O or a 0) as single dose at the age of 41-year-old for covid-19 immunisation, administered not at a military facility. Medical history included ongoing Hashimoto's disease diagnosed about 10 years ago, ongoing vitamin D deficiency diagnosed about 8 years ago, ongoing vitamin b12 deficiency diagnosed about 8 years ago, lung neoplasm malignant. Family history included: dad had lung cancer, mother had thyroid issues and Alzheimer's. The patient's concomitant medications were not reported. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of BNT162B2. No prior vaccinations (within 4 weeks). No adverse events following prior vaccinations. The patient experienced terrible pain in his stomach which made him scream to the point where he lost his voice on 24Apr2021 with outcome of recovered on 27Apr2021, metallic taste in the mouth on 23Apr2021 with outcome of recovered on 24Apr2021, had diarrhea on 24Apr2021 with outcome of recovered on 26Apr2021, a fever of 103°F on 24Apr2021 with outcome of recovered on 26Apr2021, he was shivering due to lack of energy on 24Apr2021 with outcome of recovered on 27Apr2021, lost his voice on 24Apr2021 with outcome of recovered on 27Apr2021, threw up on 24Apr2021 with outcome of recovered on 27Apr2021, sleeping for 48 hours on 24Apr2021 with outcome of recovered on 27Apr2021. The patient underwent lab tests and procedures which included body mass index: 37 on an unknown date, body temperature: 103 Fahrenheit on 24Apr2021. Therapeutic measures were taken as a result of terrible pain in his stomach which made him scream to the point where he lost his voice, had diarrhea, threw up. The course of events was as follows: Within the 1st 24 hours, he mentioned that he was fine and easy but had a metallic taste in the mouth for 24 hours. He mentioned that the next 72 hours were really bad for him. On 24Apr2021, that night, he started to feel terrible pain in his stomach which made him scream to the point where he lost his voice. It was like knives cutting his stomach. He threw up everything he ate, had diarrhea for 2 days along with a fever of 103 degree F for 2 days. He would try to go to the bathroom and he was shivering due to lack of energy that he could not go to the bathroom. He slept for 48 hours after the 1st 24 hours after vaccination due to the side effects. By Monday afternoon, 26Apr2021, he noticed that his side effects were subsiding and by Tuesday, 27Apr2021, he was a different person and was like nothing happened, he was able to resume a normal life and go back to work. The events did not require a visit to Emergency Room or physician Office. He did not go he was taking orange juice and ibuprofen to treat himself. No relevant tests. He asked if this was contraindicated with him to get the 2nd dose. He has not spoken to his doctor yet. He queried if he should get the second dose or is it contraindicated. Patient mentioned he is very large at 6'6" and 320 lbs. He is wondering if he should have a different dose because he is so big. This report is not related to a study or program. Information on Lot/Batch number was available. No further information is expected.
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| 41 | 2021-05-31 | weakness |
Rare Diagnosis of Ramsay Hunt Syndrome (Shingles in the inner & outer of the left ear & throat) aka ...
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Rare Diagnosis of Ramsay Hunt Syndrome (Shingles in the inner & outer of the left ear & throat) aka Herpes Zoster Oticus. Bedridden, Extreme fatigue, weight loss, weakness, body aches, pain in throat & ear, lymphodema, severe virtigo, tonsillitis, and permanent hearing lose.
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| 41 | 2021-06-01 | tremor |
About 8 hours after the 2nd dose my husband became very ill. Uncontrollably shaking, fever, terrib...
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About 8 hours after the 2nd dose my husband became very ill. Uncontrollably shaking, fever, terrible headache, nausea, etc. for 24 hours.
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| 41 | 2021-06-02 | pain in extremity |
Muscular pain in both upper arms well after initial vaccine reaction had subsided, normal movement o...
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Muscular pain in both upper arms well after initial vaccine reaction had subsided, normal movement of arm up and/or back and rapid movements in other axes cause intense muscle pain followed by severe minutes of pain fading to dull ache. The pain issue has only worsened since it's onset. The pain in each arm is proportionate to the initial vaccine reaction, meaning the arm that got the second dose experiences more sever pain than the one that got the first. The pain in both is preventing normal activities and affecting quality of life.
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| 41 | 2021-06-03 | pain in extremity | Foot pain that lasted over a month. Went to see pcp and couldn?t be resolved. |
| 41 | 2021-06-05 | night sweats |
I received the first vaccine without a single side effect. However, the evening after receiving my s...
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I received the first vaccine without a single side effect. However, the evening after receiving my second dose, I began to get chills, a fever of 101.7, and night sweats. The next morning I woke up to two rashes on my chest. I continued to experience chills, a fever of 102, and the rash now covers my entire body, including my face. The rash is painful, itchy, and bumpy. This is day two. I have swollen lymph nodes in my neck. The urgent care I saw today told me to watch my throat to make sure it doesn't close up.
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| 41 | 2021-06-07 | pain in extremity |
Pfizer-BioNTech COVID-19 Vaccine EUA: Myocarditis, STEMI Patient received Pfizer COVID vaccines on 4...
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Pfizer-BioNTech COVID-19 Vaccine EUA: Myocarditis, STEMI Patient received Pfizer COVID vaccines on 4/15/21 and 5/6/21. Patient presented to ED on 5/9/21 with complaints of acute onset substernal chest pain that woke him from sleep. Patient also endorses left arm pain, diaphoresis and nausea. No significant past medical history or family history of heart disease. ECG demonstrated inferior ST elevations. Patient was taken to cath lab and found to have no angiographic evidence of CAD. Patient discharged on aspirin 81 mg QD, Clopidogrel 75 mg QD, Metoprolol 12.5 mg BID, Rosuvastatin 5 mg QD.
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| 41 | 2021-06-08 | tingling, numbness |
He has had a lot of symptoms since second COVID-19 vaccine 5 weeks ago-Pfizer vaccine. Notes tinglin...
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He has had a lot of symptoms since second COVID-19 vaccine 5 weeks ago-Pfizer vaccine. Notes tingling and numbness in his left arm, dizzy, nausea, "brain fog" and "loosing motor skills". Headaches are tapering off. He is on Amantadine from Neurology. His symptoms came on immediately after the 2nd shot. Severe symptoms- headache , brain fog. Had been in ED- had CT head. Saw neurology and then sent to Headache clinic. He has several people he knows with similar symptoms and had gone thru long term
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| 41 | 2021-06-09 | one side paralysis |
Blood clot in left side of brain resulting in stroke and reduced functionality of the right side of ...
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Blood clot in left side of brain resulting in stroke and reduced functionality of the right side of my body.
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| 42 | 2021-01-04 | flushing, weakness, feeling of body temperature change |
Red rash at injection site (left shoulder) and red rash on left, middle and right neck 9 hours after...
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Red rash at injection site (left shoulder) and red rash on left, middle and right neck 9 hours after administration, also weakness, flushed, hot and cold chills without fever 26 hours later. Red rash disappeared within 1.5 hours after taking ibuprofen.
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| 42 | 2021-01-04 | flushing, feeling cold |
Empoyee received his 1st dose of Covid-19 vaccine around 1535 on 12/17 at our vaccination clinic. A...
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Empoyee received his 1st dose of Covid-19 vaccine around 1535 on 12/17 at our vaccination clinic. Around 1545, while being monitored by a registered nurse, he leaned over and grabbed his head. The nurse asked if he was okay and he reported, "no". He stated that he felt nauseated. V/S obtained: B/P 158/80; pulse 99; resp 24; O2 sat 99% on RA; FSBS 267. Pupils were slow to react. Skin was flushed and red. Dr. was notified and assessed the employee. At 1558, the Dr. ordered Benadryl 50mg IM. This was given to employee in Left Deltoid IM at 1558 by RN. At 1559, patient complained of heache, chest tightness, being cold. At 1606, O2 sat was 99% on RA; B/P was 126/90. He reported that his headache was going away at that time and that the chest tightness was going away as well. Headache at that time was a 4/5 on pain scale. Recommended that he be checked at the ER. Between 1620-1625, first responders on site. At 1630, employee was transported to ER for evaluation. Status at time of transfer: Alert and Oriented; headache better, nausea getting better.
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| 42 | 2021-01-06 | tingling |
Scaled 0-10 Pain at the injection site (6): Can not raise left arm higher than shoulder level Fatigu...
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Scaled 0-10 Pain at the injection site (6): Can not raise left arm higher than shoulder level Fatigue (8) New or worsened muscle pain (8) New or worsened joint pain (8) Nausea (9): took zofran Vomiting (8) Fever (7): 101F: took tylenol 650 mg Q3 hours since 23:00 on 1/6/2021, 3:00, 6:00, 8:00, 11:00 Chills (8) Other: Burning on urination, eyes burning, left side face tingling,
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| 42 | 2021-01-07 | numbness | complaints of a headache, right side face swelling and numbness, and right sided chest pain |
| 42 | 2021-01-08 | pain in extremity | Fever, uncontrolled rigors, extreme/uncomfortable aching of the feet and hands that awoke from sleep |
| 42 | 2021-01-10 | tingling, numbness |
slight fever sweatiness after 15-30 minutes throat started to close up, difficult to swallow and bre...
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slight fever sweatiness after 15-30 minutes throat started to close up, difficult to swallow and breath tingly and numb around nose this lasted for about an hour
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| 42 | 2021-01-11 | flushing |
Approximately 30 minutes after receiving his 2nd dose of the Pfizer COVID vaccine he had sudden onse...
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Approximately 30 minutes after receiving his 2nd dose of the Pfizer COVID vaccine he had sudden onset of dizziness, nausea, and feeling flushed. He went to Emergency Department for treatment. He was discharged from the Emergency Department to home. On 1/12/21 he states nausea and dizziness gone. Slight headache. Feels better.
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| 42 | 2021-01-12 | weakness |
DEVELOPED DIZZINESS, EXTREME FATIGUE, CHILLS, WEAKNESS, NIGHTMARES AND ELEVATED BLOOD PRESSURES SINC...
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DEVELOPED DIZZINESS, EXTREME FATIGUE, CHILLS, WEAKNESS, NIGHTMARES AND ELEVATED BLOOD PRESSURES SINCE 1/12/2021 AT NIGHT. UNABLE TO GO TO WORK.
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| 42 | 2021-01-13 | feeling hot |
Pt complained of "warm rush feeling" similar to after first dose. No reports of pain or shortness of...
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Pt complained of "warm rush feeling" similar to after first dose. No reports of pain or shortness of breath, dizziness, rash, or itchiness. VS monitored, BP initially 196/106, resolved to 137/94 upon recheck. HR 90s- 120 sinus rhythm. PO fluids and supine position for one hour until resolution of symptoms. Discharged and advised to follow up with primary care and allergist as needed. Safety maintained.
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| 42 | 2021-01-13 | hot flush | Systemic: hot flashes since receiving vaccine, otherwise feels fine-Mild |
| 42 | 2021-01-16 | pain in extremity |
The day after the vaccine i started to feel this sharp pain in the right side of my lower back in th...
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The day after the vaccine i started to feel this sharp pain in the right side of my lower back in the area of the right kidney and today being 12:49 am on 01/17/2021 the pain is located in both sides of my back in the kidney are but is going to the front of my stomach and giving me chills every now and then i have muscle pain from my back al the way to the legs no fever or problems to breath
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| 42 | 2021-01-18 | hot flush |
Last night had heart burn worse then had in years. hot flashes with no temp. muscles soreness and so...
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Last night had heart burn worse then had in years. hot flashes with no temp. muscles soreness and soreness in joints. symptoms are still happening currently
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| 42 | 2021-01-19 | pain in extremity, tremor, feeling cold |
The evening of receiving the vaccine developed body aches, chills, fever, fatigue, headache and sore...
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The evening of receiving the vaccine developed body aches, chills, fever, fatigue, headache and sore throat. tested on 12/24/20 for covid results negative. After 10 days developed full body tremors, now improving and then after 2.5 weeks had difficulty walking and leg pain/discomfort. Blood work on 1/13 revealed CPK of 934
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| 42 | 2021-01-20 | muscle spasms |
Fever, body aches, and headache as expected starting about 9 pm on 1/17. On 1/18 in late afternoon ...
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Fever, body aches, and headache as expected starting about 9 pm on 1/17. On 1/18 in late afternoon developed severe cramping in stomach, chest and upper back. Did not eat after cramping started. Got worse at approx 11 pm. Resolved by at approx 3 am on 1/19, after fever broke. Have continued to have headache through time of this report submission.
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| 42 | 2021-01-20 | pain in extremity |
01/20/2021: Headache and light headedness 10 mins after receiving vaccine. Waited and completed the ...
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01/20/2021: Headache and light headedness 10 mins after receiving vaccine. Waited and completed the 30 mins observation period before returning to work, then took ibuprofen for the headache. About an hour later post nasal drip started, lasted about 2-3 hours or so. Around 4-5pm headache returned, left arm soreness increased (felt like the arm was swung on by a bat), persisted all night. Took ibuprofen around 11 pm before going to bed. 01/21/2021: Woken up at 5 am with a headache and joints were sore especially my troubled joints (knees and lower back). Generalized fatigue experienced as well. Took Ibuprofen at 08:20 for the headache, joint soreness and fatigue still present.
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| 42 | 2021-01-21 | migraine |
01/13:BODY ACHES, HEADACHE,FATIGUE, 01/14: FEVER AND CHILLS, 01/15: HIGH BLOOD PRESSURE,NAUSEA 01/1...
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01/13:BODY ACHES, HEADACHE,FATIGUE, 01/14: FEVER AND CHILLS, 01/15: HIGH BLOOD PRESSURE,NAUSEA 01/16: HEADACHE AND MINDGRAINE
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| 42 | 2021-01-21 | tremor | Severe chills, shaking, pain in right hip, ribs, headache, fever 101.3, body aches |
| 42 | 2021-01-21 | tremor |
for roughly 40 hours I experienced a fever as high as 102.9, shaking, chills, body aches, headache, ...
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for roughly 40 hours I experienced a fever as high as 102.9, shaking, chills, body aches, headache, right kidney pain
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| 42 | 2021-01-25 | throat numbness |
Entered observation @ 1832. @ 1836, stated that his throat was numb. Pt was with the nurse into cl...
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Entered observation @ 1832. @ 1836, stated that his throat was numb. Pt was with the nurse into clinic and had pt sit on the bed in clinic. @ 1838 Benadryl 25mg was given. Denies SOB or Trouble Breathing. @ 1843 pt states that s/s had been alleviated. Insist to this nurse that he has no trouble swallowing nor breathing. States that his throat does not feel as if it is closing up. Just states that his throat feels numb. @ 1850 remains to voice that he has no s/s of throat feeling numb. Pt left observation @ 1855. Denies this to this nurse SOB or Trouble Breathing.
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| 42 | 2021-01-27 | facial pain, nerve pain |
mild to moderate neuropathic pain starting at injection site, shooting distally towards the dorsum o...
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mild to moderate neuropathic pain starting at injection site, shooting distally towards the dorsum of arm and hand, has progressively worsen over the past day and starting today towards neck (L) and left side of face.
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| 42 | 2021-01-28 | weakness, tingling |
Tingling hands, Feeling weak and tired Patient alert and oriented noted with tingling sensation in b...
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Tingling hands, Feeling weak and tired Patient alert and oriented noted with tingling sensation in both hands at around 5:35 pm, 6 minutes after being vaccinated for 1st dose of PFizer CoviD 19 vaccine. Vitals signs taken BP 156/96, HR 115, RR 20, T 98, O2 sat 98% RA. Patient offered beverage and tolerated well. Patient was monitored, Vitals re checked as Follows: BP 129/80, HR 105, RR 18, O2 sat 99% RA. At around 6:05 PM Patient verbalized that tingling was gone, monitoring continues, pt. noted anxious at all times. Patient states that he is taking Citalopram 30 mg For 2 years. Vitals rechecked at 7 PM BP 148/88, P 134, RR 20 MD evaluated pt with recommendation to send pt to ER For Further (monitor) evaluation. EMS arrived at 7:22 pm and take over the pt. Patient left Ambulating with Wife and EMS.
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| 42 | 2021-01-28 | numbness |
This is a spontaneous report from a contactable consumer (patient). A 42-year-old male patient recei...
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This is a spontaneous report from a contactable consumer (patient). A 42-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3248, expiration date 30Apr2021), via an unspecified route of administration on 09Jan2021 at single dose for COVID-19 immunization. Medical history included asthma. Concomitant medication included salbutamol (ALBUTEROL) for asthma. The patient experienced left side of his face went numb, his eye became swollen on 09Jan2021 with outcome of recovered. Caller stated this lasted 8 hours and then went away. Caller stated he used an ice pack during the reaction. The outcome of the events was recovered on 09Jan2021.
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| 42 | 2021-01-29 | pain in extremity, tremor |
Woke up at 1:30am with stomach pain, then chills followed by uncontrollable shaking - No fever - Lef...
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Woke up at 1:30am with stomach pain, then chills followed by uncontrollable shaking - No fever - Left arm pain and constant head ache for 36hrs after second vaccine - No reaction after the first round of vaccine
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| 42 | 2021-01-31 | unresponsive to stimuli |
1/28/2021- Seen by FNP for indigestion, chest pressure and palpitations. EKG reviewed and referral ...
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1/28/2021- Seen by FNP for indigestion, chest pressure and palpitations. EKG reviewed and referral made to Cardiology. 1/29/2021-1800 Presented to ED in cardiac arrest-onset PTA. Patient was found unresponsive by his wife at their home. The last known well was at 1530 when she called him on the phone. The patient was pronounced at ~1850.
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| 42 | 2021-02-04 | tremor, feeling cold |
I didn't have any symptoms all day, then I woke up at 1:30AM with my left arm (injection site) hurti...
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I didn't have any symptoms all day, then I woke up at 1:30AM with my left arm (injection site) hurting and swollen and I was violently shaking. Hypothermia. Couldn't get warm. It's like my body forgot how to regulate temperature. I've only ever experienced similar coming out of anesthesia after surgery. Took wearing multiple layers of clothes AND multiple blankets just to stabilize my body temp. It lasted for around 2-3 hours. This wasn't normal "chills". This was whole-body shaking hypothermia. Entire body sore afterwards from the involuntary shaking. Unfortunately, I didn't get an actual reading as anything to measure body temp was downstairs and I didn't want to risk falling.
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| 42 | 2021-02-05 | weakness |
On January 18, two days after getting the first dose of the vaccine I woke up with a sense of fullne...
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On January 18, two days after getting the first dose of the vaccine I woke up with a sense of fullness or pressure in my left ear, mild sinus congestion, and chills. The congestion and chills ended after one day, but the feeling of fullness in the ear has persisted to this day. Then, on January 29, I had a bout of positional vertigo and vomiting that lasted two to three hours. I also experienced ringing or roaring in my left ear. Ever since, I have a bout of vertigo approximately every 24 hours, and the ringing and sense of fullness in the ear ebb and flow on 24 hours cycles as well. This experience has been debilitating and affected my ability to work. My doctor has diagnosed Meniere's disease and says he has been seeing similar symptoms apparently linked to the COVID vaccines. I started taking prednisone on doctor's orders yesterday (February 5), which has stopped the vertigo. Ringing and occasional fullness in the ears persist.
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| 42 | 2021-02-06 | feeling cold |
Flu-like symptoms. Aches, fever, chills. Began the morning after the shot. Ended the following mo...
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Flu-like symptoms. Aches, fever, chills. Began the morning after the shot. Ended the following morning.
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| 42 | 2021-02-07 | night sweats |
Increased soreness at injection site. Followed by nausea. For next two days: nausea, chills, night s...
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Increased soreness at injection site. Followed by nausea. For next two days: nausea, chills, night sweats, fever, Diarrhea
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| 42 | 2021-02-07 | pain in extremity |
My shoulder started having a light burn and after the next six days it got worse and worse - my left...
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My shoulder started having a light burn and after the next six days it got worse and worse - my left shoulder. I got x-rays and started doing physical therapy. I took Tylenol for pain. Started improving - I'm probably about 40% better. I received the second dose on January 20th - just had a slightly sore arm.
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| 42 | 2021-02-07 | tingling, numbness | numbness and tingling in left arm and leg |
| 42 | 2021-02-07 | tingling, cold extremities |
Prior to vaccination, patient admitted to taking 25MG of benadryl PO. 3:30 PM: patient received his ...
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Prior to vaccination, patient admitted to taking 25MG of benadryl PO. 3:30 PM: patient received his 2nd dose of the Pfizer COVID-19 vaccine. 3:48 PM: Onset of throat itching and tingling sensation of the right lower extremity. 3:48 PM vitals: BP 137/76, spO2 100%, HR 108, T 98.3F 3:48 PM: Benadryl 25MG IM was given in the left deltoid. 4:03 PM vitals: BP 116/67, spO2 98%, HR 95, T 98.4F. Patient said that he felt a headache that was 2/10 on the pain scale, reported less tingling in his his leg that was mostly felt in his R big toe, and felt some tingling left in his throat but says that "it's nothing." 4:50 PM: Patient's hands felt cold compared to his arms. Patient reported feeling cold in his arms and very tired. 4:55 PM: Patient was transported to the emergency department for further evaluation.
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| 42 | 2021-02-09 | migraine |
Minor swollen lymph nodes were first observed on day 3 pm at the patient?s neck same side as the inj...
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Minor swollen lymph nodes were first observed on day 3 pm at the patient?s neck same side as the injection (left arm). Since then severe swollen lymph nodes have been developing on multiple areas from shoulder, along the neck, to face/back of ear, same side (left) of the shot. Sizes of some areas are more than 1 square inch. Other symptoms including, migrate, mild fever and fatigue.
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| 42 | 2021-02-15 | feeling hot, tremor | Tremors, feeling hot. Diagnosed with autoimmune disorder graves disease. |
| 42 | 2021-02-16 | feeling cold, cold sweat |
13:35 pm - Pt found as beginning to slump over in chair. Assisted from chair to floor. Pt lying down...
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13:35 pm - Pt found as beginning to slump over in chair. Assisted from chair to floor. Pt lying down, responding to stimuli, eyes opened and closed. Answered questions appropriately. Episode lasted approximately 2-3 minutes. Pt cold and clamy. V/S taken BP 144/113, pulse 59, temp 96.7. O2 98%. Pt stated had hx of lightheadedness once as a teenager when having blood drawn. 13:46 V/S BP 151/106, pulse 72. Patient stated feeling comfortable. 13:50 Pt sitting up in chair. 2 pm BP 146/105, pulse 72. Pt states feeling better and cooler. given bottled water. 14:20 pm Pt left on own stated friends to meet him at site.
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| 42 | 2021-02-17 | feeling hot |
Complaining of feeling warm at head/chest, feeling need to take deep breaths about 5-10 minutes post...
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Complaining of feeling warm at head/chest, feeling need to take deep breaths about 5-10 minutes post vaccination. Was given an ice pack and allowed to lie down on gurney. Afterwards, individual felt significantly better with the cold therapy and resting, reported symptoms had resolved by 1611 same day.
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| 42 | 2021-02-23 | feeling hot |
Felt immediate headache, followed by extreme exhaustion, fatigue, body aches (the same day as the 2n...
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Felt immediate headache, followed by extreme exhaustion, fatigue, body aches (the same day as the 2nd dose) within about 10 minutes after it; and for the next two days. Felt better by 02/14/2021. Began feeling ill again on 02/17/2021, body aches, extreme fatigue, feeling very hot but not having a fever, nausea. It seemed to get better on about 02/21/2021, but then on 02/22/2021, all of the same feelings and symptoms came back and are still present today. I have reached out to my primary doctor to let him know and he suggested that I submit this information here as well.
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| 42 | 2021-02-24 | difficulty speaking |
Patient became diaphoretic, reported tingling on tongue, hoarse voice. Hx. of allergies. Epi admin...
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Patient became diaphoretic, reported tingling on tongue, hoarse voice. Hx. of allergies. Epi administered on site. Patinet transferred to ED and discharged with prednisone.
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| 42 | 2021-02-24 | numbness, tingling, muscle twitching |
Since receiving the vaccine on 02/23/2021, my left arm muscle has been twitching. I have been havin...
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Since receiving the vaccine on 02/23/2021, my left arm muscle has been twitching. I have been having tingling down my left arm with my hand and fingers going numb.
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| 42 | 2021-02-25 | tremor, flushing |
Systemic: Flushed / Sweating-Medium, Systemic: Hypertension-Mild, Systemic: Hyperventilation-Medium,...
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Systemic: Flushed / Sweating-Medium, Systemic: Hypertension-Mild, Systemic: Hyperventilation-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Mild
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| 42 | 2021-03-02 | burning sensation |
random heart-racing; random dizziness; occasional headaches; Temperature between 100-102 for 30hrs; ...
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random heart-racing; random dizziness; occasional headaches; Temperature between 100-102 for 30hrs; flu-like symptoms; extreme burning resulting in fainting; extreme burning; This 42-year-old male patient contactable consumer (reported for himself) received the second dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) (lot EN5318,; expiration not provided), via an unspecified route of administration, on 14Feb2021, 12:00 PM (at the age of 42-year-old) as a single dose for COVID-19 immunization, in Left arm. The facility where COVID-19 vaccine was administered was at a hospital. Prior to the vaccination, the patient was not diagnosed with COVID-19. Historical Vaccine included first dose of BNT162B2 (Lot number: el8982) intramuscularly on 24Jan2021 at 09:00 am for COVID-19 immunization on left arm. The patient did not have any other vaccine within four weeks prior to the vaccination. No relevant medical history reported. Concomitant medication included: Levothyroxine 125 "mg", once a day. On 14Feb2021 at 12:15pm, the patient experienced extreme burning resulting in fainting. Ekg normal in ER. Day-2 flu-like symptoms, temp between 100-102 for 30hrs. Day-2 and now day-3, random dizziness, feeling of heart beat, random heart-racing, occasional headaches, no current fever. Events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The clinical outcome of the events extreme burning resulting in fainting, flu-like symptoms, temp between 100-102 for 30hrs, random dizziness, random heart-racing, occasional headaches, was unknown. It was reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.
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| 42 | 2021-03-02 | hypersensitivity of all senses, bell's palsy, numbness, tingling |
Shortly after receiving shot in left shoulder, I began to feel sensitivity/tingling in left jaw. A ...
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Shortly after receiving shot in left shoulder, I began to feel sensitivity/tingling in left jaw. A few minutes later, the left side of my face felt heavy/full/numb/tingling. This persisted throughout the remainder of the day along with feeling woozy and having a bad headache. Headache and wooziness were gone by next day but left facial heaviness, fullness, numbness and tingling persisted and is still present today. Not as bad today but still under left eye, along left jaw and mouth, and parts of left cheek. Had teledoc visit with doctor the evening of the shot and he diagnosed as Bell's Palsy.
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| 42 | 2021-03-02 | tingling |
15 minutes after injection, both arms and hands experienced a tingling sensation similar to when a l...
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15 minutes after injection, both arms and hands experienced a tingling sensation similar to when a limb "falls asleep". This continued for about 8 hours. When I went to sleep and woke up, the tingling sensation was gone. Tingling on the lower arms (below elbow) and hands.
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| 42 | 2021-03-03 | pain in extremity | Headache, body ache, fatigue, high temp but not fever level, sore arm. |
| 42 | 2021-03-07 | flushing | Pre syncopal , dizzy, flushing, diaphoretic. Evaluated by EMS-Cleared |
| 42 | 2021-03-07 | nerve pain |
shingles; rash; shoulder pain; little nerve pain thing; This is a spontaneous report from a contacta...
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shingles; rash; shoulder pain; little nerve pain thing; This is a spontaneous report from a contactable consumer (patient). A 42-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: from vaccine card: EL then either 0 or O 142), via an unspecified route of administration by injection once to left arm on 13Jan2021 at single dose for prevention (covid-19 immunisation). Medical history was none. There were no concomitant medications. Patient was diagnosed with shingles about 3 weeks after receiving his first injection of the Pfizer covid-19 vaccine. This male consumer received his first injection of the Pfizer-BioNTech COVID-19 vaccine on 13Jan2021. He reported being diagnosed with shingles last Thursday (04Feb2021) and stated his symptoms started that same week (Feb2021), which were described as rash and shoulder pain. He reported his shingles are improved and are scabbing over. The consumer was prescribed and was taking valacyclovir for treatment of the shingles. Shingles was now (base on 09Feb2021) healing. Shingles occurred after the first dose, he was not blaming the vaccine, he did fine, he had no reaction, his first dose was on 13Jan2021, and shingles came up last week (on 04Feb2021). The consumer's second dose of the covid-19 vaccine was supposed to be last week (base on 09Feb2021) but this physician recommended he delay due to the shingles. Currently on an antiviral, getting better, feels great, wondering if he can proceed with second dosage. The consumer was wanting to get his second dose this week (base on 09Feb2021). No investigation Assessment. Outcome: he scabbed up, he never had fever, just a rash and the little nerve pain thing (Feb2021), that's it. Stated he had no reaction to the vaccine whatsoever. The outcome of shingles was recovering, of other events was unknown. Information on the lot/ batch number has been requested.
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| 42 | 2021-03-08 | pain in extremity |
On February 11, 2021 aprox 1pm, I received first dose of Pfizer COVID-19 Vaccine. Developed left arm...
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On February 11, 2021 aprox 1pm, I received first dose of Pfizer COVID-19 Vaccine. Developed left arm pain specially at movement that started around 6-7pm but did not limited movement. Symptom was completely resolved in less than 24 hours. On March 4, 2021 aprox 1pm, I recieved second dose of Pfizer COVID-19 Vaccine. Developed left arm pain specially at movement that started around 6-7pm but did not limited movement. Pain was less intense than with first dose. Symptom was completely resolved in less than 24 hours.
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| 42 | 2021-03-08 | tenderness |
swelling; red spots; tenderness on my right big toe and the toe next to it; This is a spontaneous re...
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swelling; red spots; tenderness on my right big toe and the toe next to it; This is a spontaneous report from a contactable consumer (patient). A 42-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot #: EL3247) via an unspecified route of administration on 19Jan2021 (at the age of 42-years-old) as a single dose for COVID-19 immunization. Medical history was reported as none. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not have any known allergies. The patient did not receive any other medications within two weeks prior to the vaccination and did not receive any other vaccines within four weeks prior to the vaccination. On 30Jan2021 the patient experienced swelling, red spots and tenderness on my right big toe and the toe next to it. The clinical course was reported as follows: "two weeks after my COVID-19 vaccination I noticed swelling, red spots, and tenderness on my right big toe and the toe next to it. I visited my podiatrist who recommended NSAIDs for a week. Today, my sister in law who is a nurse said it looked like COVID toes. When I googled an image of COVID toes, the spots looked identical to my own." The adverse events required a physician office visit. The patient received treatment for the events which included NSAIDs. The clinical outcomes of the events swelling, red spots and tenderness on my right big toe and the toe next to it were all not recovered/not resolved. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 42 | 2021-03-10 | bell's palsy | PATIENT RECEIVED SHOT ON 2/25/2021 AND ON 3/7/2020 PT STARTED SHOWING SIGNS OF BELL'S PALSEY |
| 42 | 2021-03-11 | weakness, tremor |
After about 12 hours, I was woken up from sleeping with extreme body aches/headache and starting get...
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After about 12 hours, I was woken up from sleeping with extreme body aches/headache and starting getting the chills and shaking. I lost all energy and struggled to get out of bed and walk. Laid in bed all day, took Tylenol, slept off and on. Didn't subside until 6:00pm the next evening when I broke out in a sweat and got some energy back.
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| 42 | 2021-03-11 | feeling hot, flushing | Flushed, hot, dizzy started at 12:10 after shot. |
| 42 | 2021-03-11 | sensory loss, feeling cold |
Stomach tightness upon waking at 6am. At 12pm felt cold and like was about to get sick. By 1pm in be...
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Stomach tightness upon waking at 6am. At 12pm felt cold and like was about to get sick. By 1pm in bed with multiple layers of clothes, under multiple blankets with heat cranking. Uncontrollable chills, shivering and teeth chattering. Hands white and lost sensation in fingers. 105 fever. Chills lasted a couple of hours, fever lasted 3 full days. Day 1: 105; Day 2: 102; Day 3: 100; Day 4: No fever. Stomach tightness remains.
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| 42 | 2021-03-12 | pain in extremity | Fever, body aches, headache, dizzy, no appetite, arm pain |
| 42 | 2021-03-12 | tremor |
Excessive swelling at injection site (golf ball sized knot) with tenderness to the touch 103.8 temp ...
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Excessive swelling at injection site (golf ball sized knot) with tenderness to the touch 103.8 temp started 12hrs after injection and lasted for 48hrs Blurred vision during onset of Temp. Muscle pain/ fatigue during onset of Temp. Full body aches during onset of Temp. Chills with moderate spells of hands shaking during onset of Temp Loss of appetite during onset of Temp.
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| 42 | 2021-03-13 | tingling | paresthesia |
| 42 | 2021-03-15 | numbness, speech disorder |
Patient was given vaccine at approximately 10:20am and completed 15 minute monitoring in office. Pat...
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Patient was given vaccine at approximately 10:20am and completed 15 minute monitoring in office. Patient returned to clinic at approximately 10:45 with complaints of left arm numbness, tongue tingling, tongue swelling, and speech difficulty. 0.3mg Epipen and 50mg benadryl was administered and patient immediately reported resolution of tongue swelling and speech difficulty. Patient was transported via EMS per clinic protocol.
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| 42 | 2021-03-21 | weakness |
Intense flu symptoms for three days, to include fever chills, aches, swelling of face and neck. Subs...
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Intense flu symptoms for three days, to include fever chills, aches, swelling of face and neck. Subsequent to flu, low oxygen rates of 82-91, low resting heart rate of 48-54, extreme exhaustion, swelling of face and neck. General weakness.
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| 42 | 2021-03-22 | seizure like phenomena |
Patient was normal upon administration. Was given instruction to wait 15 minutes in the pharmacy to ...
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Patient was normal upon administration. Was given instruction to wait 15 minutes in the pharmacy to monitor for adverse reaction, per protocol. Pharmacy staff was alerted by customer that patient was "not looking good". As we walked to patient, we slipped out of his chair and appeared to loose consciousness and/or have seizure-like symptoms. Patient looked very pale, perhaps had some minor foam at the mouth and was extremely hot. We stayed by patient, protected his head, allowed him to come to, took coat off and applied ice packs, took BP/pulse (normal) and patient was oriented x3. EMS arrived and took over.
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| 42 | 2021-03-23 | unresponsive to stimuli |
Description of event: Patient received vaccine in his LUE and was instructed to wait in line to sche...
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Description of event: Patient received vaccine in his LUE and was instructed to wait in line to schedule next dose. While standing in line, patient was witnessed falling to the floor. He appeared to land on his hands, denies injury at this time. Patient responded verbally when asked if he was okay. Vitals recorded while patient sitting on floor 1500. Patient stated he was ok to sit in chair. Upon sitting in chair for approximately 30 seconds his head fell forward and he was unresponsive. Patient began agonal breathing, eyes were open with fixed pupils, pulse was weak. Staff assisted patient to floor where he regained consciousness after approximately one minute. Patient appeared diaphoretic and pale, but was responding appropriately. An ambulance was called during this time. The patient was able to give contact information for his wife. The patient personally spoke to her on the phone. Meanwhile patient was resting supine on the floor. Vitals at 1552 146/94 P 70, R 20, 98% RA. Approximately 15 min later patient returned to the chair and has been resting since. BP at 1615 119/65. He refused treatment from EMS and is currently calling his wife to pick him up as staff has advised him not to drive. Patient currently eating a snack and drinking water, states he is feeling better.
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| 42 | 2021-03-24 | numbness |
Approximately 15 minutes after injection, I first felt tightness in my left neck area, followed by a...
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Approximately 15 minutes after injection, I first felt tightness in my left neck area, followed by a numbness sensation on the left side of my face and abdomen. Sensation has subsided in the abdomen area but remains on the left side of the face. Lower left eyelid twitches on its own throughout the day.
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| 42 | 2021-03-24 | pain in extremity |
3/4 Moderate stomach cramps day after vaccine. Much less arm pain then following first dose but stil...
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3/4 Moderate stomach cramps day after vaccine. Much less arm pain then following first dose but still present. 3/9 Work up with terrible thoracic back pain with every breath. Went to ER and received shot of Toradol and chest x-ray (negative). Shortly thereafter, had chills and low grade fever. Alternated naproxen and tylenol for the next two days as fever persisted. 3/11 Moderate chest pressure when breathing. Went back to ER. Received COVID test (negative). No fever or chills. 3/12 Light headedness, racing heartbeat and chills early afternoon. Went back to ER. Received Flu test (negative). Blood work showed positive d-dimer test. CT scan showed small pneumonia in lower left lung. Started Amoxicillin and Z-pack. Symptoms improved over course of following 7 days.
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| 42 | 2021-03-24 | tingling |
Complained of feeling weird/ tingly. No sense of pain to pinch. Dulled responses. Acting without ...
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Complained of feeling weird/ tingly. No sense of pain to pinch. Dulled responses. Acting without inhibition- wanted to pour water all over self, sleep face down in the grass, fly a plane. Acting inebriated or drugged.
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| 42 | 2021-03-25 | weakness |
Diaphoretic, felt weak. Vitals wnl. Did not eat as usual in the morning. Offered water, juice, and c...
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Diaphoretic, felt weak. Vitals wnl. Did not eat as usual in the morning. Offered water, juice, and crackers.
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| 42 | 2021-03-26 | tremor |
Started was a very cramped stomach and then the rest followed. Whole body turned red including eyes....
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Started was a very cramped stomach and then the rest followed. Whole body turned red including eyes. Upset stomach with vomiting and diarrhea. Body was shaking and didn?t have a fever. Skin felt like it was burning whole body felt swollen. Started around 2:30am with the cramping. It woke me up. Once I got up everything came so fast. Was rushed to hospital where I was admitted very quickly. I was blacking out on the drive there and blacked out while in their care. This was from one dose of Pfizer vaccine for Covid. I was put on a GI, Allergy, and steroid medications. I was hooked up to an IV and 3 drugs were injected. I passed out numerous times but was discharged at 5am.
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| 42 | 2021-03-27 | burning sensation |
Itchy/burning rash formed on both wrists and back of hands. Symptoms started easing on their own ab...
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Itchy/burning rash formed on both wrists and back of hands. Symptoms started easing on their own about an hour after they started. Diphenhydramine 25mg was taken a couple hours after the event started and seemed to help reduce the symptoms further and cleared them up. No re-emerging of symptoms have occurred since.
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| 42 | 2021-03-27 | depressed level of consciousness, unresponsive to stimuli, seizure |
Patient received the vaccination and after he got up from the chair, he passed out and fell to the f...
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Patient received the vaccination and after he got up from the chair, he passed out and fell to the floor. The intern notified the pharmacist. When I went to see that patient, he was laying on the floor with his eyes rolled in the back of his head and was unresponsive. He was not alert. He started having a mild seizure and I rolled him over on his left side. While I was bracing the patient, pharmacist came in and administered an Epi-pen to his left thigh. Patient stopped seizing so I rolled him back on his back. He became alert and was able to provide me his name, DOB and what he was at the pharmacy for. I rested my hand under his head and monitored his pulse until the paramedics arrived
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| 42 | 2021-03-28 | migraine |
Chills, body aches, migraine headache, nausea. Nausea has continued to be a big issue from the night...
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Chills, body aches, migraine headache, nausea. Nausea has continued to be a big issue from the night of injection until today, which is Monday, 3/29/2021. On Saturday night (3/27) I experienced overwhelming stomach pain and nearly passed out on my toilet multiple times during a bout of diarrhea.
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| 42 | 2021-03-30 | bell's palsy |
2 weeks after the 1st vaccine shot I was diagnosed with bell's palsy. The right side of my face shut...
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2 weeks after the 1st vaccine shot I was diagnosed with bell's palsy. The right side of my face shut down. I lost the sense of taste on that side. I was prescribed Valacyclovir HCL 1 gram tablets and Prednisone 20 MG tablets on 3/15/21.
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| 42 | 2021-03-30 | slurring |
Equatable to the description of Alzheimer's or dementia patients; disorientation; confusion; Knowing...
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Equatable to the description of Alzheimer's or dementia patients; disorientation; confusion; Knowing your doing something wrong and unable to correct it; Motor skills slowed; Fuzzy tongue; generally out of sorts feeling; This is a spontaneous report from a contactable consumer (patient). This consumer reported that a 42-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6207) at the age of 42-years, via an unspecified route of administration in left arm at 12:15 AM on 16Mar2021 at single dose for COVID-19 immunisation, in Public Health Clinic. Medical history was reported as none. No other vaccine in four weeks. No COVID-19 prior vaccination. No known allergies. Concomitant medications were not reported. At 08:30 AM on 17Feb2021, the patient had periods of disorientation, confusion. Equatable to the description of Alzheimer's or dementia patients. Knowing you doing something wrong and unable to correct it. Motor skills slowed. Fuzzy tongue, and generally out of sorts feeling. Punctuated by periods of lucidity. No treatment received. Outcome of the events was recovering. No Covid-19 tested post vaccination.
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| 42 | 2021-03-30 | feeling of body temperature change, night sweats |
Flu like symptoms next day. Vomiting and diarrhea. Body aches. Hot and cold sweats and chills. N...
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Flu like symptoms next day. Vomiting and diarrhea. Body aches. Hot and cold sweats and chills. Night cold sweats during brief sleeping periods. Third day was the same. Loss of appetite and dehydrated. Severe itching on my back. Today is the fourth day and I broke out with a rash on my back. Cortisone has relieved it thus far. My appetite is back. I did not vomit but still experiencing diarrhea.
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| 42 | 2021-03-30 | hot flush |
Fatigue/More fatigue; slight dizziness; slight nausea; slight fever; hot and cold flashes; This is a...
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Fatigue/More fatigue; slight dizziness; slight nausea; slight fever; hot and cold flashes; This is a spontaneous report from a contactable consumer(patient). A 42-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number: EN5318), first dose via an unspecified route of administration, administered in Arm Left on 02Feb2021 09:30 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 02Feb2021, the patient experienced Fatigue, slight dizziness, slight nausea, slight fever, hot and cold flashes. More fatigue then anything. The patient's lab tests included body temperature: slight fever on 02Feb2021. The outcome of the event was recovering for Fatigue, unknown for Dizziness, Nausea, Pyrexia, Hot flush.
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| 42 | 2021-03-30 | numbness, tingling |
Shortly after injection, the pt developed dizziness and tingling/numbness in extremities. He was not...
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Shortly after injection, the pt developed dizziness and tingling/numbness in extremities. He was noted to be diaphoretic. HR 70, SP02:99%, BP 110/70. Symptoms resolved after appx. 15 minnutes. The pt was feeling completely back to normal before he departed. Family drove him home.
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| 42 | 2021-03-30 | paralysis |
Loss of hearing to last less than 5 min. followed by ringing ears through the following day. Uncon...
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Loss of hearing to last less than 5 min. followed by ringing ears through the following day. Uncontrolled palsy for head and neck intermittently through the injection day. I lost my voice and had spasms in my larynx. For several hours I had a hard time choosing my words and speaking which was the scariest. I could not focus enough to even wash my hands on injection day and had to be driven home from work. I got dehydrated because water tasted horrible. The next morning I am better on all fronts except the ringing in my ears wont stop
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| 42 | 2021-03-31 | burning sensation |
I got my 2nd shot on March 26th. On Monday March 29th 6:00pm, my elbows started to itch and develop...
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I got my 2nd shot on March 26th. On Monday March 29th 6:00pm, my elbows started to itch and develop hives/rashes. Then my knees and then foot and hands by the night. It was burning and itching and it swelled up a little. Oddly the itchiness and redness goes away and then comes. Taking Allegra does help but its not making the symptoms go away.
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| 42 | 2021-03-31 | feeling of body temperature change | Headache began 12 hours after shot. Fever Hot/cold sweats Severe nausea Body aches Extreme fatigue |
| 42 | 2021-03-31 | numbness | Right hand numbness. Refused TRANSPORT BP 183/102 88 16. Has an appt with Cardiologist |
| 42 | 2021-03-31 | tingling |
Pfizer-BioNTech COVID-19 Vaccine EUA Tiredness, soreness at injection site, body aches, tingling, fe...
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Pfizer-BioNTech COVID-19 Vaccine EUA Tiredness, soreness at injection site, body aches, tingling, fever up to 101 degrees
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| 42 | 2021-04-01 | migraine |
1 ? I had really bad headaches the night the vaccination was administered. 2 ? The next morning I ha...
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1 ? I had really bad headaches the night the vaccination was administered. 2 ? The next morning I had a REALLY bad ocular migraine when I woke up. The duration was 24-36 hours.
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| 42 | 2021-04-04 | numbness and pain in extremities, numbness |
Although I had symptoms of Erythromelalgia prior to the vaccine, flares have increased over last few...
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Although I had symptoms of Erythromelalgia prior to the vaccine, flares have increased over last few weeks. Symptoms include daily: 1) Erythromelalgia flares (numbness, redness, searing heat from hands and feet, particularly in PM) 2) peripheral neuropathy (wrist, hands, knuckles, feet). 3)Joint pain, numbness, and swelling (knees, wrists, knuckles)
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| 42 | 2021-04-05 | bell's palsy | Bell?s Palsy |
| 42 | 2021-04-05 | tremor, feeling hot |
Patient was given first dose of Pfizer COVID-19 vaccine. I counseled the patient on side effects an...
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Patient was given first dose of Pfizer COVID-19 vaccine. I counseled the patient on side effects and asked him to wait 15 minutes afterwards in our waiting area. After about 5 minutes, the patient starting complaining of feeling dizzy. We asked him to sit back in the chair and brought him a bottle of water. I asked the patient if he had eaten today and he replied no. I offered a snack and also a glucose tablet to help with shakiness. As I went to get a bottle of glucose tablets off the shelf, the patient fainted and fell out of his chair. I immediately ran to get an Epipen while my technicians called for a Code White and 911. I was about to inject the patient with the Epipen when he came to about 10 seconds later. He said he was really hot, sweaty, dizzy, and nauseous. Paramedics and AP arrived to evaluate him and take a statement. Patient left on his own will and received a ride home from his mother-in-law, who is an associate at our store.
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| 42 | 2021-04-06 | burning sensation |
Patient was in clinic parking lot post observation after first dose of covid vaccine when he decided...
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Patient was in clinic parking lot post observation after first dose of covid vaccine when he decided to return to the clinic for what felt to him as "burning sensation" to back of neck and head. Patient was observed to have raised reddened spots behind neck and on scalp(patient is bald). Patient was also observed to have reddened spots on his back--but patient was unsure if those were there prior to vaccine.
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| 42 | 2021-04-06 | discomfort |
1 minute after vaccine injection I experienced a tightening of my throat. It was very uncomfortable...
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1 minute after vaccine injection I experienced a tightening of my throat. It was very uncomfortable and made it difficult to swallow and felt like a "lump in my throat". I asked an onsite nurse if this was a common reaction, and she offered medical attention. I denied it because it was not getting worse. She gave me a bottle of water and it seemed to help it a bit while drinking. But, quickly returned after water was swallowed. I was monitored for 30 minutes as recommended. The tightness remained for 1 hour post vaccine injection and disappeared as quickly as it started. I fear the second dose may be worse.
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| 42 | 2021-04-07 | tingling |
Twenty minutes after injection patient reported tingling to left arm and back. Faint pale pink macu...
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Twenty minutes after injection patient reported tingling to left arm and back. Faint pale pink macular rash to left forearm. VSS. No reported distress. Within 20 min patient reported decreased tingling. Faint rash remained. D/C'd home.
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| 42 | 2021-04-08 | night sweats |
I have had Night sweats every night since the second vaccine. no other symptoms during the day. ju...
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I have had Night sweats every night since the second vaccine. no other symptoms during the day. just at night. Had no issues prior to vaccine. Today would be 2 weeks post. Woke up 3 times drenched last nights and had to sleep in different locations in the home becuase the bed was wet with sweat.
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| 42 | 2021-04-08 | pain in extremity |
I had a strange feeling in the left side of my face that I wasn't sure if it was a reaction or not. ...
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I had a strange feeling in the left side of my face that I wasn't sure if it was a reaction or not. It happened within the first 15 minutes but did not last more than 30 minutes. I did not experience anything else until the first evening when my arm was very sore. The next day my arm was more sore and I had a mild circular red mark around the injection site and the arm was much harder on that side. I also felt a little in my back and neck. By the second day in the evening the only thing I felt was pain in the arm which eventually traveled into my armpit by day 3. It wasn't until day 5 that all the pain was completely gone. I may have experienced fatigue the first two days also.
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| 42 | 2021-04-09 | feeling cold |
Experienced normal soreness the evening of 4/9/2021. At 2:30 pm on 4/10/21, started having generaliz...
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Experienced normal soreness the evening of 4/9/2021. At 2:30 pm on 4/10/21, started having generalized soreness. Temp at that point was 98.6. Within ten minutes, started having congestion in chest (rattles). This caused strong bouts of coughing with pain radiation through my lungs. I then started vomiting (x3). I started feeling fatigued so I went to lie down, when I had a cold chill. At 3:00 pm, my temp was 102 F. At 3:15, it was 102.5 F, and then crested at 103 F at 3:30. In the past five hours, the only symptom to subside was vomiting; all the others are still present with my current temp 102.1 F at 8:41 pm.
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| 42 | 2021-04-09 | pain in extremity | High fever, chills, body aches, extremely sore arm, heart racing. |
| 42 | 2021-04-09 | pain in extremity |
small pneumonia in lower left lung; Light headedness; racing heartbeat; Moderate chest pressure when...
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small pneumonia in lower left lung; Light headedness; racing heartbeat; Moderate chest pressure when breathing; work up with terrible thoracic back pain with every breath; chills; low grade fever; Moderate stomach cramps; Much less arm pain then following first dose but still present; This is a spontaneous report from a contactable consumer (patient). A 42-year-old male patient received second dose of BNT162B2, (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6203) via an unspecified route of administration in left arm on 03Mar2021 (at the age of 42-year-old) at single dose for COVID-19 immunisation. There was no medical history. The patient had no known allergies. The patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9267) on 10Feb2021 at 11:30 am in left arm for Covid-19 immunisation. There were no other vaccines in four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had 3/4 moderate stomach cramps day after vaccine on 04Mar2021. Much less arm pain then following first dose but still present on 04Mar2021. The patient 3/9 worked up with terrible thoracic back pain on 09Mar2021 with every breath and went to emergency room and received shot of Toradol and performed chest x-ray which was negative. Shortly thereafter, the patient had chills and low grade fever on 09Mar2021. Alternated naproxen and tylenol for the next two days as fever persisted. The patient had 3/11 moderate chest pressure when breathing and went back to emergency room on 11Mar2021. There was no fever or chills but had 3/12 light headedness, racing heartbeat and chills early afternoon on 12Mar2021. The patient went back to emergency room. The patient's symptoms improved over course of following 7 days. The patient underwent lab test and procedure which included flu test and resulted negative; blood work which showed positive D-dimer test on an unknown date and CT scan showed small pneumonia in lower left lung on 12Mar2021. The patient started to receive amoxicillin and Z-pack. Since the vaccination, the patient had been tested for COVID-19 by nasal swab on 11Mar2021 and tested negative. Events resulted in emergency room/department or urgent care. The outcome of event pneumonia was unknown; for other events was recovering. No follow-up attempts are possible. No further information is expected.
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| 42 | 2021-04-09 | pain in extremity | Dizziness, bad headaches, severe soreness in arm, blurred vision, drowsiness. |
| 42 | 2021-04-10 | tremor | severe trembling and chills (rigors) for minutes in 3 waves. |
| 42 | 2021-04-11 | pain in extremity |
felt tiredness on 3/28; sore arm showed up on 3/29 and disappeared in about 2 days. However, the vac...
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felt tiredness on 3/28; sore arm showed up on 3/29 and disappeared in about 2 days. However, the vaccine arm pain comes back on 4/11, 2 weeks after the vaccine. it is occasional sharp pain around the injection area. still have ongoing pain.
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| 42 | 2021-04-11 | pain in extremity |
Joints became sore and right foot very tight the night following shot (4/3/2021). Pain continued to...
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Joints became sore and right foot very tight the night following shot (4/3/2021). Pain continued to build following day (4/3/2021 aka Easter). By 9:30 PM on the night of 4/3 the large right toe had swollen and was unable to move. By the morning of 4/4/2021 no pressure could be placed on the right foot without extreme pain. Pain reached highest pain by 4/7/2021 and has slowly tapered but remains. Swelling has reduced to point where a lose shoe can be placed over foot and some walking can occur with effort. Joint pain continues in shoulders, knees and hips. I become winded after walking only a few hundred feet. (typically jog 2 miles/day and walk an additional 5 miles)
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| 42 | 2021-04-12 | cold sweat |
PATIENT REPORTED FEELING SWEATY, CALMMY, AND FELT LIKE HE WAS GOING TO PASS OUT. HE WAS LAID DOWN AN...
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PATIENT REPORTED FEELING SWEATY, CALMMY, AND FELT LIKE HE WAS GOING TO PASS OUT. HE WAS LAID DOWN AND FEET ELEVATED. NO C/O PAIN OR DISCOMFORT. VITAL SIGNS AS FOLLOWS: 14:15 HR- 68 RESP 18 BP 138/85 O2 @ 96% RA 14:20 HR- 69 RESP 18 BP 138/82 O2 @ 97% RA 14:25 HR- 75 RESP- 18 BP- 132/82 O2 @ 98% RA. 14:30 HR- 71 RESP- 18 BP- 139/81 O2 @ 97% RA. PATIENT WITH NO C/O PAIN OR DISCOMFORT. RELEASED BYSELF TO HOME.
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| 42 | 2021-04-12 | numbness, bell's palsy |
Started having neck pain on a Thursday, my taste buds became less sensitive but I could still taste ...
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Started having neck pain on a Thursday, my taste buds became less sensitive but I could still taste on Friday and late Saturday night my left side of face started feeling numb. Went to hospital on Sunday morning when I woke up since left side of face was completely numb. Diagnosed with Bell's Palsy.
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| 42 | 2021-04-12 | tremor |
Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadedness-Medium, Systemic: Shakiness...
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Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadedness-Medium, Systemic: Shakiness-Mild.
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| 42 | 2021-04-13 | numbness |
Patient received 2nd dose of covid vaccine and stated that fingers felt numb and tongue was slightly...
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Patient received 2nd dose of covid vaccine and stated that fingers felt numb and tongue was slightly numb. After 20 minutes EMTs were called and patient was checked out clear and refused services
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| 42 | 2021-04-14 | burning sensation |
Experienced pain in lower back, lower spine area one day after shot #1. That went away after about ...
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Experienced pain in lower back, lower spine area one day after shot #1. That went away after about a week. After second dose (3 weeks after 1st one), I had no side effects until a few days after when I got the same lower back / spine aching and pain. About a week and a half after second dose, the lower back pain moved to my left hip area and red spots appeared shortly after (a day or two after the hip pain). The spots on my left hip and butt area started to burn and feel irritated... I had mild aching in my pelvis area and lower back (spine) a few days after the shot and still today. I went to the doctor 2 days ago and am currently being treated for shingles. I am a runner, and ever since I got the 1st covid vaccine shot, my running performance has been worse... my pace per mile is about 20% worse (consistently) since the 1st shot. I feel like it did something to my immune system and am still getting over it.
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| 42 | 2021-04-14 | numbness |
Starting the night of the injection, my left arm gets numb from my elbow to my fingertips. Only my r...
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Starting the night of the injection, my left arm gets numb from my elbow to my fingertips. Only my ring and pinky finger are affected. The color and temp of the fingers are normal, but it feels like the circulation is cut off. If I get up and work it for about a half-hour it is completely normal (and stays so throughout the day). This wakes me up 3-4 times a night and continues to this day >3 weeks later. I started Zeposia medication a few days before this shot. I didn't have this effect with my 2nd shot in my other arm. I did use an ax to chop wood for 4 hours 2 days before the shot, and my arm was sore from that before the injection. It's possible this is unrelated to the shot altogether, and I did something to trigger some sort of carpal tunnel with the ax. I plan on discussing with my Dr at some point.
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| 42 | 2021-04-14 | numbness |
Patient received 2nd dose of covid vaccine and stated that fingers felt numb and tongue was slightly...
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Patient received 2nd dose of covid vaccine and stated that fingers felt numb and tongue was slightly numb. After 20 minutes EMTs were called and patient was checked out clear and refused services
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| 42 | 2021-04-15 | feeling hot, feeling cold |
Extreme soreness and discomfort at base of skull, sinus cavity?s below eyes felt inflamed and dried,...
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Extreme soreness and discomfort at base of skull, sinus cavity?s below eyes felt inflamed and dried, unable to sleep or get comfortable, alternated between feeling chills and feeling overheated, vomiting
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| 42 | 2021-04-15 | feeling hot |
- Sore arm around the injection area for approximately 4 days after shot. - Very mild body warming a...
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- Sore arm around the injection area for approximately 4 days after shot. - Very mild body warming and aches app. 12 hours after shot that lasted for 2-3 hours.
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| 42 | 2021-04-15 | cold extremities, flushing, unresponsive to stimuli |
Site: Pain at Injection Site-Mild, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Swe...
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Site: Pain at Injection Site-Mild, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Additional Details: AFTER 5 MINUTES OF BEING VACCINATED, PATIENT WAS SEATED WAINTING FOR THE 15 MINUTES AND FAINT LOSSING CONSCIOUSNESS FOR 5 MINUTES, THEN AFTER RECOVERED HE WAS PALE, SWEATING, COLDNESS OF THE HANDS AND DIZZY. WHEN 911 ARRIVED, HE SAID THAT HAD NOT EATEN ANYTHING SINCE 5:00 AM, 10 HOURS BEFORE THE EVENT HAD PLACE, SO MAYBE HE EXPERIENCED A HYPOGLYCEMIC EVENT.
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| 42 | 2021-04-18 | discomfort |
I developed Shingles approximately 1 week after vaccine was administered. My PCP placed me on 7-day...
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I developed Shingles approximately 1 week after vaccine was administered. My PCP placed me on 7-day antiviral course. Still having itching and discomfort even after rashes cleared up.
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| 42 | 2021-04-18 | slurring |
Pt was found in severe distress in the bathroom by his wife. He couldn't walk or stand, complained ...
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Pt was found in severe distress in the bathroom by his wife. He couldn't walk or stand, complained of being dizzy with slurred speech and was throwing up a lot. 911 was immediately called. The EMTs during their assessment said his BP was normal but when he was asked his name, he started saying the alphabet"ABC... XYZ". He was transported by ambulance to ER. Cat scan showed he had a bleed on the brain. The doctors told us it was because he had very high blood pressure, however where the bleed was, they said he wouldn't need surgery and that the body would reabsorb it over time. He was admitted to the ICU and has been there ever since. Several days later, he started having difficulty breathing and they discovered several blood clots in his right leg that had broken off into his heart and lungs. He had emergency surgery to remove the clots in his heart (approximately 10) and was given heparin in small doses over an 8 hour period so that it wouldn't cause the bleed in his brain to increase. The doctor should fill in the rest.
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| 42 | 2021-04-19 | seizure like phenomena |
While in waiting area client experienced loss of consciousness and seizure-like activity lasting app...
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While in waiting area client experienced loss of consciousness and seizure-like activity lasting approximately 48 seconds per nurse that responded to incident. Loss of bladder control noted. Squad responded and transported patient to the hospital via ambulance. Patient was coherent prior to transport. He states he was admitted to the hospital and Observation x 24 hours. He had a CT scan and bloodwork, both normal. Neurologist at the hospital told him he experienced syncope and no seizure activity was suspected. He states a history of feeling faint when he sees blood. He sates the Neurologist advised he get the second dose and lay down after the shot.
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| 42 | 2021-04-20 | discomfort |
Tightness/squeezing's sensation in both arms occurring around a minute after injection VS 125/76 mm ...
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Tightness/squeezing's sensation in both arms occurring around a minute after injection VS 125/76 mm hg, 90 bpm, 96% RA No CP, SOB, pruritis, hives abdominal pain or diaphoresis. Heart lungs clear to auscultation, no oropharyngeal/lip/face/tongue swelling, no hives, no stridor. No significant PMH, no allergies Resolved by 13:13 without intervention, no meds given Pt advised to seek immediate evaluation if symptoms returns or if developing CP or SOB
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| 42 | 2021-04-20 | facial paralysis, bell's palsy |
I developed loss of taste and mild paralysis of the left side of my face about 8 hours after receivi...
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I developed loss of taste and mild paralysis of the left side of my face about 8 hours after receiving the vaccine. I went to urgent care. Was diagnosed with Bell's Palsy. I had Bell's Palsy about 20 years ago and went away after a couple weeks. Haven't had any symptoms since.
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| 42 | 2021-04-20 | tingling, numbness |
I woke up on Monday morning with both feet feeling like they were asleep. Tingling in the toes. Th...
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I woke up on Monday morning with both feet feeling like they were asleep. Tingling in the toes. This has continued for the last three days and it has gone up my legs to my waist over the last 2 days. Both legs feel numb most of the day. I can still function but it is very noticeable.
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| 42 | 2021-04-21 | tenderness | Right side of bottom lip is swollen and painful to the touch. |
| 42 | 2021-04-22 | seizure, unresponsive to stimuli |
42 y/o male, past medical history of Anxiety, who presents with possible seizure post vaccination. P...
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42 y/o male, past medical history of Anxiety, who presents with possible seizure post vaccination. Patient notified one of the observation nurses that he was not feeling well. The NP was assisting another patient but saw that the patient with his head back and pale. As soon as the NP was at the patient side, it was noted that the patient?s eyes were rolling back, his face was pale, and his lips were blue. The NP attempted a sternal rub with no response from patient. NP instructed police to please call Fire Rescue to transport patient to the ER. Patients left upper extremity was flexed at the elbow and stiff. At that time the patient was placed on the floor by several nurses and the paramedic and patient legs were elevated. Within 10-15 mins patient immediately sat up but was instructed to lay down. Patient was placed on 3L of O2 by nasal cannula and vitals were taken. Patient initial vitals 166/94 L Arm, 98% 3L O2, 84 Pulse and EKG was NSR. Patient no longer with pallor and lips were pink. Patient states that he isn?t feeling well and feels a nervousness throughout his body. Patient placed on stretcher in Trendelenburg. Vitals retaken, 137/97 BP, 98% 3L O2, 80 P. Patient pulses were thready and patient became diaphoretic. Fire Rescue arrive to site and transported patient to the ER. CNO and PM present during event and aware that patient transported to the ER for further evaluation
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| 42 | 2021-04-23 | pain in extremity |
About six hours after receiving my shot, my arm became extremely sore, as to be expected. Circa 9pm...
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About six hours after receiving my shot, my arm became extremely sore, as to be expected. Circa 9pm I began to have significant trouble breathing, experienced acute pain in my abdomen, and began to hear ringing in my ears combined with feeling like I was going to pass out. I didn?t feel dizzy, rather I started getting tunnel vision that blocked out more of my field of view as the ringing increased. Circa 11pm, I lost consciousness while trying to move and collapsed on the floor. My wife called 911 while I was unresponsive, and I regained consciousness while being attended to by EMTs who checked my vitals. Around 12am I didn?t feel like I was going to lose consciousness again, and the EMTs recommended I be taken to the hospital. Since I was feeling better I politely declined. Today I am still feeling foggy and have joint pain (in addition to some bruising from falling after losing consciousness , but I no longer have the acute abdominal pain.
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| 42 | 2021-04-24 | bell's palsy |
Bell's Palsy; This is a spontaneous report from a contactable consumer (patient). A 42-years-old mal...
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Bell's Palsy; This is a spontaneous report from a contactable consumer (patient). A 42-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: ER8732), via an unspecified route of administration, administered in Arm Right on 26Mar2021 14:30 (at 42-years-old) as single dose for COVID-19 immunization. Medical history included Ankylosing Spondylitis and Iritis. Patient had no known allergies. Patient had no covid prior vaccination. Patient was not tested with covid post vaccination. Vaccination facility type was School/Student Health Clinic. Concomitant medications included certolizumab pegol (CIMZIA); brimonidine tartrate. The patient experienced bell's palsy on 06Apr2021 08:00 with outcome of not recovered. Event resulted in Emergency room/department or urgent care. Treatment given was Methylpred Na Succinate, Prednisone, and Acycolvir.
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| 42 | 2021-04-24 | bell's palsy |
Right sided Bell's Palsy Grade IV; This is a spontaneous report from a contactable physician. A 42-Y...
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Right sided Bell's Palsy Grade IV; This is a spontaneous report from a contactable physician. A 42-Year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: Unknown) intramuscular, administered in left arm on 15Mar2021 (at the age of 41-years-old) as SINGLE DOSE, dose and second dose was intramuscular, administered in left arm on 05Apr2021 as SINGLE DOSE for covid-19 immunization. Medical history included covid-19 and ongoing allergies. Concomitant medication was Benadryl PRN for allergies. On 09Apr2021,the patient experienced right sided bell's palsy grade iv. The patient underwent lab tests and procedures which included sars-cov-2 test was pending on 09Apr2021 Covid test type post vaccination done by nasal swab. Therapeutic measures were taken as a result of right sided bell's palsy grade iv included Prednisone Taper and pain medication. The outcome of event was not recovered. Information about the Lot/batch number has been requested. ; Sender's Comments: Considering a plausible temporal relationship, a possible contributory role of suspect vaccine BNT162B2 to the reported event facial paralysis cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 42 | 2021-04-24 | cold sweat |
Patient warned us before his covid vaccine that he has a severe needle phobia and has fainted after ...
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Patient warned us before his covid vaccine that he has a severe needle phobia and has fainted after vaccines. I gave him his immunization quickly and he did well. He stood up and watched as I immunized his wife. He said he was feeling okay afterwards so both him and his wife left the immunization room. Shortly after leaving he must have started getting dizzy, because next thing I hear is that there is an unconscious man in the waiting room. He is sitting in a chair with his head back unresponsive. His wife if rubbing his arms and lightly slapping his face. He comes to, and we decide to move him to the room that the clinic uses (we have a walk in clinic staffed with a NP). He lays on the floor, and within a minute he proceds to vomit approximately 4 times. He also lost control of his bladder. He was pale with cold and clammy skin. we moved him so we could put his feet up on a chair and allowed him to rest. Someone went to get him an ice pack to put on his head and chest. His blood pressure was low (90/50ish). He still was not feeling better after 30 minutes so we called the ambulance. He did not want to go to the hospital so the paramedics monitored him. his blood pressure slowly started going up and normalizing, and he left with his wife.
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| 42 | 2021-04-25 | bell's palsy |
Bell's Palsy - predniSONE 40 MG for 7 days valACYClovir Take 1 tablet (1,000 mg total) by mouth 3 ti...
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Bell's Palsy - predniSONE 40 MG for 7 days valACYClovir Take 1 tablet (1,000 mg total) by mouth 3 times daily
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| 42 | 2021-04-26 | pain in extremity |
Right axillary lymphadenopathy still present. Right arm pain still present. Bilateral hand rash s...
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Right axillary lymphadenopathy still present. Right arm pain still present. Bilateral hand rash still present.
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| 42 | 2021-04-28 | muscle twitching, tingling |
initially began as what felt like jolts to my chest area from inside my chest over five days beginni...
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initially began as what felt like jolts to my chest area from inside my chest over five days beginning on March 31, 21 @ 1:20am; next on April 01, 2021 @ 12:02am; then April 02, 2021 @1:02am; then April 03, 2021 @ 1:36am; and on April 04, 2021 @ 2:46am. I ended up in the emergency room the afternoon of Sunday March 04, 2021 with severe chest, abdominal, and intestinal pain. I followed up with doctors on April 05, 2021; April 09, 2021; and April 28, 2021 with continued painful symptoms described below. All they has done so far is 1) took a chest X-ray, 2) taken blood, and 3) referred me to a sleep laboratory. The X-ray and blood work came back negative per ER. Symptoms: 1. Inability to sleep. most nights feels as if I just drank five cups of coffee before bed. When I am able to fall asleep, pain and/or jolts coming from inside my trunk/core area wake me up within about an hour. 2. Constant pain coming from my chest, abdomen, and intestines. Intestinal and abdominal pain (gut wrenching, pain/burning sensation, cramps). At times feels like radiation or waves/currents are passing through my intestines/trunk. I wake up with intestines feeling sore. I also have discomfort when I eat or drink something the following morning. Also, my trunk/core area feels tight all day and night. I constantly feel a burning sensation in my chest and gut areas. The discomfort in my chest area (tightness, burning sensation) with occasional burst of pain the size of a nickel that comes from the left side of my chest and underneath my rib cage. 3. Limbs twitch/jerk on their own (both hands, both feet, neck, both shoulders, both legs, fingers) during the day and during the night. tingling sensations in legs. 4. ringing in the ears with headaches. 5. Woke up from sleep due to both nostrils getting clogged while I slept; woke up gasping for air. 6. Penis no longer has the same sensation and difficulty with erection.
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| 42 | 2021-04-28 | tingling |
Severe insomnia, severe brain fog, sinus pain, sore throat, shortness of breath, body aches and ting...
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Severe insomnia, severe brain fog, sinus pain, sore throat, shortness of breath, body aches and tingling, eye irritation, blurred vision, headaches, stomach discomfort.
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| 42 | 2021-04-29 | muscle spasms | Spiking fever, strong chills with muscle cramping all over body and headache. |
| 42 | 2021-04-29 | tremor, pain in extremity |
continuous sore arm, almost two weeks after the second pfizer vaccine shot. couldn't raise the arm, ...
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continuous sore arm, almost two weeks after the second pfizer vaccine shot. couldn't raise the arm, even for an empty dish plate, i can feel my arm is shaking when i hold it. similar situation happens after the first pfizer vaccine shot. about two weeks after the first shot, my arm had occasional sharp pain for about 3 days. no rash no swollen on arm.
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| 42 | 2021-05-02 | weakness |
On 25 April I woke up and felt fine and then at 10:30 am I started to feel weak. I had fever and chi...
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On 25 April I woke up and felt fine and then at 10:30 am I started to feel weak. I had fever and chills and couldn't get out of the bed until 4:00pm that day. I was dizzy and drove to the hospital. They did blood work and did two Covid 19 tests. They released me and the next day I developed Heavy pains. On 27 April I woke up and went back to the hospital. They said I had elevated enzyme levels when they drew blood and they started three iv?s. They said I was having a non emergency heart attack. They had me transferred by ambulance to the another Hospital. They drew more blood and did elf?s and ultra sounds. The next day they said they were going to put a stint in my heart. The next day I was prepped for the procedure and they went in and said my heart didn?t need it. The surgeon said I had Myocarditis and at 7:00 pm that night I was released. My nose broke out with acne bumps and it feels like I have a chest cold and cough.
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| 42 | 2021-05-02 | seizure, pain in extremity |
Pt had some pain in his right arm and fever after taking the vax. Next day he woke up, went to the...
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Pt had some pain in his right arm and fever after taking the vax. Next day he woke up, went to the wash room and then had a seizure. His father gave him a cold compress and provided him with water and extra seizure medicine. His father called the Neurologist. He was told to give him some Tylenol for his fever and extra seizure meds if needed and to FU w/ an office appt if he has another seizure. It had been more than a year since he has had a seizure but had one on 4/14/21 that was 3 days after taking the 1st Covid Vax.
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| 42 | 2021-05-04 | seizure | Seizure |
| 42 | 2021-05-05 | pain in extremity |
Developed severe ongoing pain in left shoulder and arm which has persisted to current date. I had mi...
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Developed severe ongoing pain in left shoulder and arm which has persisted to current date. I had minor pain prior to second vaccination but beginning in the hours immediately following the second dose it became much worse. It migrates throughout the arm and shoulder throughout the day. I am taking prescription pain medication and muscle relaxers for the first time in my life. I could not go to work for 5 days, I now can make it through the day with heavy medication. I have also been prescribed physical therapy for 7 more weeks.
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| 42 | 2021-05-06 | pain in extremity, burning sensation, limb paralysis |
Joint pain in shoulder; It felt like bursitis when he had it before on another part of his shoulder;...
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Joint pain in shoulder; It felt like bursitis when he had it before on another part of his shoulder; his arm was paralyzed and was hurting a lot/arm was painful; It is a sharp, burning, stabbing pain; Arm was paralyzed; Muscle pain at the deltoid/intense muscle pain" in the deltoid muscle; Injection was too low/Injection point was a little lower than expected; he had shoulder pain; This is a spontaneous report from a contactable consumer. A 42-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on 16Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE (at age of 42 year old )for covid-19 immunisation. Medical history included he's had bursitis previously and that the symptoms lasted 6 weeks to 6 months (reported both lengths of time, unsure which is correct duration). The patient's concomitant medications were not reported. On 16Apr2021, the patient experienced he had shoulder pain and the injection was too low/Injection point was a little lower than expected. On 17Apr2021, the patient experienced muscle pain at the deltoid/intense muscle pain in the deltoid muscle. On 20Apr2021, the patient experienced arm was paralyzed , Joint pain in shoulder, It felt like bursitis when he had it before on another part of his shoulder, his arm was paralyzed and was hurting a lot/arm was painful, It is a sharp, burning, stabbing pain.Outcome of the events Muscle pain at the deltoid/intense muscle pain" in the deltoid muscle, Joint pain in shoulder, his arm was paralyzed and was hurting a lot/arm was painful, he had shoulder pain was not recovered. Outcome of Arm was paralyzed, Injection was too low/Injection point was a little lower than expected, It felt like bursitis when he had it before on another part of his shoulder, It is a sharp, burning, stabbing pain was unknown. Information about lot/batch number has been requested.
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| 42 | 2021-05-06 | tingling, night sweats, flushing |
Got covid vaccine, had 2nd dose on March 3rd. Had about 2 days of fevers, aches, night sweats and f...
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Got covid vaccine, had 2nd dose on March 3rd. Had about 2 days of fevers, aches, night sweats and fatigue. About 1 1/2 weeks after the dose, he started to get significant fatigue. He started to sleep poorly. He developed arthralgias described as bilateral, distal joints (hip down, wrists mainly). He developed tingling sensations in his arms and legs. He has had mental fog. He had some HA and eye pain. His PCP sent him to the ED for evaluation. He was evaluated by neuro consult on 4/4, had an LP. THe LP only showed some elevated protein (somewhat traumatic tap based on 10 RBC in tube 4). MRI brain, cervical/thoracic spine was unremarkable. He was dx w/ possible post-infectious polyneurophathy, and suggested f/u w/ neuro clinic for further eval. Pt reports his paresthesias lasted 2 days and has since resolved. He has not been seen by outpatient neuro clinic yet. He did have a post LP HA which he returned to the ED for. He reports that the HA has resolved. In the past 2-3 days he has had felt less fatigue. He still has arthralgias, continuous. They do not seem to be worse in AM or PM. He can do most activities and just tired working out this week. Activity does not seem to make it better or worse. The joints are not red or swollen but feel "tight". He has not noticed any fevers but gets occasional nightsweats or sometimes feels flush and measures only a low grade temp that does not last (<100F). He has had slight decrease in wt but no change in appetite. No n/v/d. NO cough, sob, CT/CP, wheezes. No rash. He does have some sinus sx's which he thinks could be c/w seasonal allergies. Got covid vaccine, had 2nd dose on March 3rd. Had about 2 days of fevers, aches, night sweats and fatigue. About 1 1/2 weeks after the dose, he started to get significant fatigue. He started to sleep poorly. He developed arthralgias described as bilateral, distal joints (hip down, wrists mainly). He developed tingling sensations in his arms and legs. He has had mental fog. He had some HA and eye pain. His PCP sent him to the ED for evaluation. He was evaluated by neuro consult on 4/4, had an LP. THe LP only showed some elevated protein (somewhat traumatic tap based on 10 RBC in tube 4). MRI brain, cervical/thoracic spine was unremarkable. He was dx w/ possible post-infectious polyneurophathy, and suggested f/u w/ neuro clinic for further eval. Pt reports his paresthesias lasted 2 days and has since resolved. He has not been seen by outpatient neuro clinic yet. He did have a post LP HA which he returned to the ED for. He reports that the HA has resolved. In the past 2-3 days he has had felt less fatigue. He still has arthralgias, continuous. They do not seem to be worse in AM or PM. He can do most activities and just tired working out this week. Activity does not seem to make it better or worse. The joints are not red or swollen but feel "tight". He has not noticed any fevers but gets occasional nightsweats or sometimes feels flush and measures only a low grade temp that does not last (<100F). He has had slight decrease in wt but no change in appetite. No n/v/d. NO cough, sob, CT/CP, wheezes. No rash. He does have some sinus sx's which he thinks could be c/w seasonal allergies. Got covid vaccine, had 2nd dose on March 3rd. Had about 2 days of fevers, aches, night sweats and fatigue. About 1 1/2 weeks after the dose, he started to get significant fatigue. He started to sleep poorly. He developed arthralgias described as bilateral, distal joints (hip down, wrists mainly). He developed tingling sensations in his arms and legs. He has had mental fog. He had some HA and eye pain. He was dx w/ possible post-infectious polyneurophathy, and suggested f/u w/ neuro clinic for further eval. Pt reports his paresthesias lasted 2 days and has since resolved. He has not been seen by outpatient neuro clinic yet. He did have a post LP HA which he returned to the ED for. He reports that the HA has resolved. In the past 2-3 days he has had felt less fatigue. He still has arthralgias, continuous. They do not seem to be worse in AM or PM. He can do most activities and just tired working out this week. Activity does not seem to make it better or worse. The joints are not red or swollen but feel "tight". He has not noticed any fevers but gets occasional nightsweats or sometimes feels flush and measures only a low grade temp that does not last (<100F). He has had slight decrease in wt but no change in appetite. No n/v/d. NO cough, sob, CT/CP, wheezes. No rash. He does have some sinus sx's which he thinks could be c/w seasonal allergies. Now experiencing substantial disruption of the ability to conduct normal life functions, including the ability to work.
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| 42 | 2021-05-16 | grand mal seizure | Taken to ER with Grand mal seizures & possible stroke; admitted to hospital with seizures |
| 42 | 2021-05-16 | pain in extremity, burning sensation |
At first it was a lot of joint and muscle pain all over, and then I got shingles by the weekend. I t...
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At first it was a lot of joint and muscle pain all over, and then I got shingles by the weekend. I thought they were bug bites and I wasn't sure where all the pain was coming from and I ended up in the emergency room where I was diagnosed with shingles. After my second shot I started getting shingles by laterally on my right side, but I was already on medication so it didn't get that bad. I also have a lot of joint pain and burning pain in my hands and wrists that shoot up my arms and haven't stopped since the symptoms started. It's much worse at night and keeps me up from sleeping. I have also have been very forgetful and my mind is always cloudy.
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| 42 | 2021-05-17 | muscle spasms |
Pt first began to notice left leg "stiffness" after receiving his first COVID vaccine (Phizer) sever...
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Pt first began to notice left leg "stiffness" after receiving his first COVID vaccine (Phizer) several weeks ago. Pt states that after receiving his 2nd dose on 05/06, he noticed his leg stiffness got significantly worse. He tells me that he tried to "push through the pain" and mow his lawn but had to stop d/t severe cramping of the LLE and pelvis. He states he rested his leg and went to bed, and when he woke up he noticed that his left leg was severely swollen. Pt decided to take 3 days off work to continue to rest the leg, but ultimately came in for evaluation at the suggestion of his coworkers. Pt denies fever, chills, chest pain, or SOB. He denies history of smoking, prior clotting, long car travel, air travel, leg injury, or recent surgery. On exam, the left lower extremity is significantly swollen, erythematous, and hot to the touch. Physical exam otherwise unremarkable. Will admit to the hospitalist service for further medical management. ED Course: Hypertensive with BP 170/93. Initial workup significant for WBC 13, K 3.3, glucose 159. CT chest/a/p with findings suggestive of multiple PE's of the left and right lower lobes as well as extensive LLE DVT extending slightly into the IVC. Trop <0.03. BNP 66. ECG shows sinus tachycardia.
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| 42 | 2021-05-17 | pain in extremity |
After receiving my second Pfizer Covid Vaccine shot last week (11-May-2021), I suffered nose bleed (...
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After receiving my second Pfizer Covid Vaccine shot last week (11-May-2021), I suffered nose bleed (left nose) on Saturday morning (15-May-2021) and didn't think much about it. This continued Sunday (16-May-2021), Monday (17-May-2021) and also today Tuesday afternoon (18-May-2021). The amount of bleeding increased significantly through to today and the last 3 times I noticed bleeding in the back of my throat. And I initially tried applying pressure to the nose section and now it is taking more than 15 - 20 minutes for this to stop. I am very concerned and will be contacting my Primary physician as soon as possible. Actually I had 2 other instances of nose bleeds after the first shot (14-Apr-2021) but I brushed it aside thinking it was due to cold weather or irritation from picking. I have not had nose bleeds prior to this event. I did not have any fever or chills from both vaccinations other than the sore left arm so this was not weighing my mind much. However, now I am concerned at the adverse events following Pfizer Covid vaccination shots.
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| 42 | 2021-05-19 | cold sweat |
Within 10 minutes i felt clammy and light headed. I passed out in my chair. I awoke moments later ...
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Within 10 minutes i felt clammy and light headed. I passed out in my chair. I awoke moments later to fellow patients and staff tending to me. They attempted to move me to a place to lay down. I immediately passed out again trying to stand. I woke up covered in sweat lying flat on the concrete. Staff and customers did not let me fall so no trauma. They called an ambulance. My bp dropped fo 88/50 in the ambulance with a pulse as low as 36bpm. Chills and uncontrollable shivers started about 30 minutes in and lasted for 2 hours. By 3pm I felt better. 2 bags of IV, chest x-ray, and blood work showed everything normal. Home now and will update my report if anything changes. Feeling much better as of 7pm. I belive they called it normal Sinus rhythm with sinus arrythmia
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| 42 | 2021-05-20 | tingling, facial paralysis, discomfort, seizure, weakness, inability to speak, sensory loss, speech disorder |
Within 3-5 minutes developed dizziness, tingling in feet and hands, elevated blood pressure, mild na...
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Within 3-5 minutes developed dizziness, tingling in feet and hands, elevated blood pressure, mild nausea. Within an hour started having trouble with focusing his vision. Was given IV fluids at hospital in ER 5 hours after the injection, while leaving the hospital developed a slight limp on right leg Felt feverish when he got home, took Tylenol when he got home. Noted extreme fatigue. The next morning was lethargic, dizzy and right side of face felt heavy, around 11 am. Called for a telemedicine visit around 12:30p. Became weak and unable to use right side of body, upper and lower extremities and right side of face was drooping, visible to wife. Wife had support of right side of body to move around. Went to urgent care around 2p. During urgent care evaluation, his vision became more impaired and speech became unclear, had to really focus to speak. Transferred to ER. Lost ability to write name, couldn't respond when asked for SSN. Admitted as a "stroke 4". Had CT scan, CT angiogram, MRI, blood labs, cognitive tests, neurologic tests. Neurology consult. Had lost sensation to heat and pressure. All imaging and labs were normal. After MRI, had convulsions. Wasn't dx'd as a seizure. Neck felt tight afterwards. Admitted to hospital x 1 week. Had a burning, red, rash on hands, feet. No bumps, hives, but just a "splotchy" red discoloration on surface of skin that would burn and itch, often flaring at night. Rx'd ativan. Checked for autoimmune disease, Bell's palsy, followed by neurologists, repeat MRI normal. Started to improve, discharged after one week with no clear diagnosis. Discharged to rehab facility. Patient preferred to transfer care to outpatient rehab service closer to home with more social support. Repeat hospitalized 3 weeks later, less extreme, went back to ER, stroke eval neg. Developed more aphasia. Called back to ER for further evaluation of C-spine due to mild abnormality on first scan. On further evaluation not thought to be connected to symptoms. EEG report pending. +Right hemiplegia, aphasia persists. +Rash, itching, burning persist.
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| 42 | 2021-05-23 | weakness, pain in extremity |
At about noon on 01/28/21, I started to experience some fatigue. At about 9:30-10:00 PM, I started ...
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At about noon on 01/28/21, I started to experience some fatigue. At about 9:30-10:00 PM, I started to experience fever, chills, and I was very weak and fatigued. This lasted for about 3 days. I took 800 mg ibuprofen every 6 hours to manage the fever and chills. The left arm was very sore from the shot. The symptoms reminded me of what I had experienced when I had COVID in 4/2020, so I went to the doctor on 1/29/2021. I went urgent care at about 10 AM. The doctor told me to not be alarmed, because the symptoms were normal effects of the vaccine. He advised me to keep taking the ibuprofen and to possibly also take Tylenol and to monitor the symptoms. On the third day, I woke up feeling better. I didn't have chills or fever anymore. This was on 1/31/2021.
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| 42 | 2021-05-24 | facial paralysis | Facial paralysis. |
| 42 | 2021-05-25 | discomfort, sciatica |
Most, if not all, of my pain from my lower back surgery was gone. 1 week after the shot I started ha...
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Most, if not all, of my pain from my lower back surgery was gone. 1 week after the shot I started having pain in my left sciatic nerve again. It isn't as bad as it was but definitely painful. The upper back pain has came back and isn't terrible painful but is uncomfortable. Pain in most of my joints: knees, elbow, fingers... Most noticeable in my knees. (I weigh 150 pounds). I have been tired a lot. I did not have any issues with the bells palsy in my face. I received allergy shots for years and stopped getting them when I had surgery. After the surgery, I started getting the allergy shots again, it made me swell and my back pains were increased because of it. So I stopped getting them. So the issue may be that the COVID shot is making me swell.
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| 42 | 2021-05-25 | pain in extremity |
3 pulmonary embolisms; he started having really bad headaches; he was complaining of the back of his...
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3 pulmonary embolisms; he started having really bad headaches; he was complaining of the back of his leg hurting; his left shoulder started bothering him and it was radiating from his shoulder up to his chin as well as; This is a spontaneous report from a contactable consumer. A 42-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EW0172, Expiration Date 31Aug2021) via an unspecified route of administration, on 28Apr2021 at 09:00 (at the age of 42-years-old) as a single dose in the left "shoulder" for COVID-19 immunization. The patient's medical history and concomitant medications were denied (reported as "He has no medical conditions and does not take any regular medications"). The patient did not receive any other vaccinations within four weeks prior to the vaccine. The reporter says she is reporting on behalf of her husband with regard to the Pfizer COVID vaccination. She just wanted to report that her husband got the first shot 28Apr2021 and Friday 07May2021 he was admitted to the hospital with 3 pulmonary embolisms. When asked when the pulmonary embolism began she says the week before the hospitalization, so the week he actually got the first dose, he was complaining of the back of his leg hurting, in the upper calf area. She says it was either the day after the shot or the next day that he said his leg hurt but he did not think too much about it and it resolved after a couple days and then Wednesday, 05 May 2021 he started getting discomfort in his left upper quadrant, she clarifies his abdomen and rib cage area, and he started having really bad headaches Thursday that continued and during the night Thursday night his left shoulder started bothering him and it was radiating from his shoulder up to his chin as well as he had the severe headache so the doctor told him to go to the ER. The patient experienced three pulmonary embolisms on an unspecified date with outcome of not recovered. The patient was hospitalized for 3 pulmonary embolisms from 07May2021 to 08May2021. He also started having really bad headaches on an unspecified date with outcome of unknown and he was complaining of the back of his leg hurting on an unspecified date with outcome of recovered, his left shoulder started bothering him and it was radiating from his shoulder up to his chin on an unspecified date with outcome of unknown. The reporter commented that she and her husband wanted to report this because of the timing of getting the shot and they are waiting now to go see his primary care they are supposed to be calling to set up an appointment because he is supposed to be having the second dose 19May2021 so they do not know what is going to happen. Therapeutic measures were taken as a result of pulmonary embolism and included Eliquis which he would be on for at least 3 months.
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| 42 | 2021-05-26 | weakness |
Weakness began after first dose and was accompanied by malaise. Second dose intensified symptoms an...
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Weakness began after first dose and was accompanied by malaise. Second dose intensified symptoms and progressed to body aches, loss of taste and smell, episodes of sweating, shivering and brain fog.
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| 42 | 2021-05-26 | tremor |
pain at injection site 24 hours later; Fever; chills/shakes; joint pain; muscle pain; fatique; restl...
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pain at injection site 24 hours later; Fever; chills/shakes; joint pain; muscle pain; fatique; restlessness; difficulty concentrating; gas; extreme thirst; headache; shakes; This is a spontaneous report from a non-contactable other hcp (health care professional). A 42-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9262) via intramuscular route of administration, administered in left arm on 02Feb2021 at 09:00 (at the age of 42-year-old), at a single dose for covid-19 immunization in doctor's office/urgent care. The patient had no allergies and medical history. Concomitant medications were not reported. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL3246) via intramuscular route of administration, administered in left arm on 11Jan2021 at 11:45, at a single dose for covid-19 immunization and received Influenza vaccine (within 4 weeks of vaccine) on an unknown date for immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 02Feb2021 at 19:00, after receiving the second dose of vaccine the patient experienced fever, chills, joint pain, muscle pain, fatigue, restlessness, difficulty concentrating, gas, extreme thirst, headache, shakes and on 03Feb2021 (24 hours later), the patient experienced pain at injection site. The patient did not receive any treatment for the events. The outcome of the events was recovering. No follow-up attempts are possible. Information about lot/batch number could not be requested. No further information is expected.
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| 42 | 2021-05-27 | pain in extremity |
I almost immediately started getting soar in my arm. After a few hours my arm down to my elbow was ...
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I almost immediately started getting soar in my arm. After a few hours my arm down to my elbow was VERY soar, my back around my shoulder blade became soar, and over my shoulder up to my neck into the left side of my head was very soar and achy. Headaches were present most of the first day. That night, around supper time I felt nauseous and then had some severe stomach cramps. I didn?t sleep well and woke up with the same bad pain from my elbow to my shoulder and also my shoulder blade to my neck and head. Most of the symptoms were gone after 48 hrs.
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| 42 | 2021-05-27 | pain in extremity |
He got his vaccine, his arm was a little bit sore. The next day he was unbelievably tired, wiped ou...
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He got his vaccine, his arm was a little bit sore. The next day he was unbelievably tired, wiped out at around 1:00 He also had a headache and also his blood sugar was elevated quite a bit, in the high 200's. Normal BS's are from 35-150. This lasted for approximately 8-9 hours after that, and was back to his normal self by 9-10:00 PM. He has done well since.
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| 42 | 2021-05-27 | pain in extremity |
1st day - very sore arm of injection, dizziness, and fatigue. 2nd day - very sore arm, dizziness, e...
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1st day - very sore arm of injection, dizziness, and fatigue. 2nd day - very sore arm, dizziness, extreme muscle fatigue, headache, nauseous, shortness of breath, and chest pains radiating to my left shoulder/arm. At one point late in the evening of the 2nd day after the vaccine, I considered calling for medical assistnce. I was unable to sleep well for the first 3 days after the vaccine. 3rd day - sore arm, dizziness, extreme muscle fatigue, neck pain, headache, and nauseous. 4th day - fatigued and somewhat dizzy from time to time.
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| 42 | 2021-05-28 | tingling |
The day after the vaccine I woke up with tingling in my right hand thumb and forefinger. over the...
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The day after the vaccine I woke up with tingling in my right hand thumb and forefinger. over the next couple of weeks the tingling would move around the hand and forearm. I also started experiencing my face turning red. I had been building a playground in the backyard with power tools and plenty of sun during the unseasonably warm March, so i assumed the symptoms were related to some sort of physical strain. However, after an appointment in April to review symptoms, and follow-up with my primary doctor in May, i'm not being referred to neurology for review. I don't have a diagnosis, only symptoms at this moment that line up closely to the vacation but also line up closely to an out door home project. The symptoms are intermittent but are moving to more of a daily basis.
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| 42 | 2021-05-31 | muscle spasms |
Patient received vaccine at 14 days after first dose rather than at 21 days after first dose. Patien...
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Patient received vaccine at 14 days after first dose rather than at 21 days after first dose. Patient reported that he experienced left sided body muscle aches/spasms, fatigue, neck pain and visual disturbances on 5/29/21. Stated his heart felt like it was racing for a short time but it may also have been anxiety because he knew his dose was given early. Symptoms resolved by 5/30/21.
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| 42 | 2021-05-31 | seizure | Seizure immediately following injection |
| 42 | 2021-06-01 | weakness, tingling, feeling hot |
Patient was given has second dose of Pfizer. He did not have any reactions with his first dose. He f...
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Patient was given has second dose of Pfizer. He did not have any reactions with his first dose. He felt dizzy, nauseous and had a stomachache. He was also feeling hot and complained of feeling a tingling sensation in his fingers. This was a few minutes after the vaccine was given and he was sitting at the post-immunization area. We directed him to sit on the floor and gave him 2 cold packs to put on his neck. Patient looked pale and weak so we also gave him some cold water. After a few minutes of sitting, he asked for us to call 911. We called 911 and alerted management. After paramedics came, patient was taken away. Patient seemed to be doing fine as he was leaving. He regained color in his lips, but was still feeling the other symptoms.
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| 42 | 2021-06-01 | pain in extremity |
Caller states before with the first and second shot he got no symptoms except a sore arm; This is a ...
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Caller states before with the first and second shot he got no symptoms except a sore arm; This is a spontaneous report from a contactable consumer or other non hcp. A 42-years-old male patient received bnt162b2 (PFIZER- BIONTECH COVID- 19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient stated, before with the first and second shot he got no symptoms except a sore arm. Caller would like to know if he can go outside. Caller stated he doesn't want to make other people sick and right at the time of report he was in quarantine since he does not know if he has COVID-19 or not. Caller stated he was not going to work right now either. Caller stated he does not have a health care provider and he does not have any health insurance. Caller stated he will just be calling and going to a primary care center. Caller stated okay for someone to call him back at a later time to get more information. The outcome of the event was unknown. Information on the lot/batch number has been requested.
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| 42 | 2021-06-02 | pain in extremity |
unable to put pressure on left arm where vaccination was administered. Pain rotates from elbow to ba...
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unable to put pressure on left arm where vaccination was administered. Pain rotates from elbow to back shoulder plate.
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| 42 | 2021-06-03 | pain in extremity |
I have had arm soreness with previous vaccines. This was unbelievable, went beyond "soreness" - it ...
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I have had arm soreness with previous vaccines. This was unbelievable, went beyond "soreness" - it was severe pain. It lasted 2 days, getting a big better each day, but the amount of pain was very high. I also think the provider who gave me the injection gave it too high. When giving me the injection, he said something about the "magic bone" which does not sound right at all. It seemed definitively higher than dose 2, which I received from a nurse, and had no severe side effects.
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| 42 | 2021-06-07 | pain in extremity |
Sore Arm; This is a spontaneous report from a contactable consumer (patient himself). A 42-year-old ...
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Sore Arm; This is a spontaneous report from a contactable consumer (patient himself). A 42-year-old male patient received bnt162b2 (BNT162B2) via an unspecified routes of administration, administered in left arm (at the age of 42 years old); on 10Mar2021 at 13:30 (Batch/Lot Number: EL3247) as 1st dose, single dose, then on 31Mar2021 at 13:45 (Batch/Lot Number: EP6955) as 2nd dose, single dose; both for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and he was not tested for COVID post-vaccination. Since the vaccination, the patient has not been tested for COVID-19. On 10Mar2021 at 14:00, it was reported that the patient experienced sore arm. The patient also experienced sore arm on 31Mar2021 at 13:45. The patient did not receive a treatment for the adverse event. The outcome of the event was recovering. No follow-up attempts are needed. No further information is expected.
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| 42 | 2021-06-08 | seizure |
Medical assistant gave an initial Covid vaccination to her patient. While he was waiting his 15 minu...
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Medical assistant gave an initial Covid vaccination to her patient. While he was waiting his 15 minutes post vaccination to monitor for reactions, she noticed he was staring blankly at her. She asked if he was ok. Site Lead overheard her ask the patient and came into the room. RN noticed that he was slumped over and having a seizure. RN picked him up and placed him on the floor on his side. RN told MA to get an onsite MD and advised another RN in the room to call 911. Patient continued to seize. Blood pressure, oxygen level, and glucose levels were checked. All were within normal limits. Patient awoke and told RN he has a history of seizures but has not had his medication for a couple months. He stated that he has seizures when he gets nervous or upset. His last seizure that he could recall was a month ago. He then went into another seizure. EMS was on the scene. He came out of that seizure quickly. They placed oxygen on the patient. He wanted to sit up. RN helped him to sit up and helped him walk to the stretcher. He was awake, alert and oriented to person, place and time when he left the clinic. He was transported to Hospital per his request.
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| 42 | 2021-06-08 | tremor |
I was in the hospital I couldn't breathe and I was running a fever. I was shacking . While being in ...
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I was in the hospital I couldn't breathe and I was running a fever. I was shacking . While being in the hospital I am now on oxygen and I also got rhino virus while at the facility.
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| 42 | 2021-06-09 | pain in extremity | muscle aches, stiffness and joint pain in hands |
| 43 | 2021-01-03 | feeling hot, depressed level of consciousness, pain in extremity |
10 min after injection, my mouth started getting hot, then it moved down my throat and it was diffic...
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10 min after injection, my mouth started getting hot, then it moved down my throat and it was difficult and painful to swallow. I got quite dizzy. They initiated rapid response, when they came they simply monitored symptoms and Vitals. Blood pressure and Heart rate were elevated. after about 10 min the symptoms eased, but swallowing was still difficult and slightly painful. then a second wave of dizziness hit me and I nearly passed out. my heart rate was elevated once again and had ringing in ears. these symptoms lasted another 5-10 min then eased. I then had a headache. The symptoms didn't return, just a headache and fatigue the rest of the day. i was then given option to go to ED, which i didn't feel at that time I needed, so I left. The next day, i had some standard symptoms of pain in left arm from injection, and fatigue, but then toward the evening i developed a fever of 101 deg F than continued for a couple of hours. I used ibuprofen and Tylenol rotating to keep the fever down. On day 3 only mild fatigue.
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| 43 | 2021-01-04 | weakness |
Felt weak, dizzy, blurred vision and nausea Vitals normal except for several episodes of O2 stat 89-...
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Felt weak, dizzy, blurred vision and nausea Vitals normal except for several episodes of O2 stat 89-90. No wheezing . One dose of Diphenhydramine 25 mg dose. Back to normal in 1 hr.
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| 43 | 2021-01-04 | feeling jittery |
Anaphylaxis Narrative: Pt reported trouble swallowing around 20 minutes into the observation period ...
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Anaphylaxis Narrative: Pt reported trouble swallowing around 20 minutes into the observation period and was transferred to the treatment area in the vaccine clinic. Vital signs were assessed by a Registered Nurse and a Physician. Oxygen saturation was noted to be 88% on 2 liters of O2 by nasal cannula. Verbal order received at 10:03am from Physician and EpiPen administered to right thigh with improvement of symptoms. She was transferred to the Emergency Department (ED) via stretcher. In the ED, she was re-dosed with an EpiPen secondary to her airway type symptoms. She was reevaluated after 15 minutes and received Solu-Medrol, Pepcid, Benadryl IV, as well as IV fluids. She also received Ativan for her generalized jitteriness and anxiety. She improved and felt significantly better at approximately 11:43am. She was monitored for 3 hours in the ED and was discharged home at 3:34pm in good clinical condition and advised to continue to take Benadryl as needed. She carries and EpiPen on her person and was advised to return immediately if symptoms return.
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| 43 | 2021-01-07 | feeling hot | Palpitations facial warmth Narrative: |
| 43 | 2021-01-07 | tingling |
Patient had onset of parasthesia and itching distal to right elbow down to right wrist. No other com...
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Patient had onset of parasthesia and itching distal to right elbow down to right wrist. No other complaints, denies itchy throat or shortness of breath. No hives or rash noted. Contacted medical director and observed for 1 hour. Will have patient recontact MD for any change in symptoms.
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| 43 | 2021-01-09 | weakness |
Woke up in the morning with soreness in wrist and elbow and practically zero use of my left hand. W...
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Woke up in the morning with soreness in wrist and elbow and practically zero use of my left hand. Woke up on left side so just assumed hand was asleep. After 15 minutes of no improvement, I started to panic thinking I was having a stroke. Realizing I had no other symptoms and was feeling fine otherwise I knew that likely wasn't the case. Besides having zero strength (I did have feeling) my hand would curl inward toward my body. I could manipulate with my right hand by it would always curl back in. I was barely able to grip, would actually have to manipulate my fingers into a grasp, couldn't do it on it's own, and holding something as light as my cellphone would cause my hand to turn down towards the floor. Pain level I would only describe as soreness in my wrist and elbow. Annoying but not painful. It's now over 24 hours since symptoms first appeared and besides some slight weakness in the hand I would say I'm 95% better.
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| 43 | 2021-01-10 | burning sensation, tingling |
Recurrence of burning and tingling on right side of face in trigeminal nerve area (5th cranial nerve...
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Recurrence of burning and tingling on right side of face in trigeminal nerve area (5th cranial nerve, 2nd branch). No rash. Moderate intensity. Still ongoing. Prescription for Valacyclovir to be started today
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| 43 | 2021-01-10 | tingling |
Right Fifth Cranial Nerve, second branch distribution, burning and tingling , no rash. Presumed to ...
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Right Fifth Cranial Nerve, second branch distribution, burning and tingling , no rash. Presumed to be mild herpes zoster (shingles). Treated with Valacyclovir 1000mg TID for 7 days with resolution.
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| 43 | 2021-01-11 | bell's palsy | Patient developed Bells Palsy on day 19 after vaccine #1 |
| 43 | 2021-01-11 | pain in extremity |
myositis; This is a spontaneous report from a contactable physician. A 43-year-old male patient re...
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myositis; This is a spontaneous report from a contactable physician. A 43-year-old male patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on an unspecified date in Dec2020 reported as around the end of December, at single dose for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. On an unspecified date after he received the vaccine he had right arm pain and swelling (states it was in his bicep brachial radialis in the muscle) which is the opposite arm of the injection site. He had an MRI done on an unknown date that showed myositis. He thinks could be due to the vaccine since it started two days after he received the vaccine. His pain peaked at about a week and a half and now the pain was improving and the swelling was down. He still had function in the right arm but when he strained it would hurt. His concern was that the reaction may be an autoimmune reaction and the first response was muted. He was worried the second dose may elicit a larger response. At the time of the reporting the patient was recovering from the events. Information on Lot/Batch number has been requested.; Sender's Comments: Based on the available information, the company considers that a causal relationship between the myositis and vaccination with BNT162B2 cannot be excluded. Additional information regarding onset latency, relevant medical history, concomitant medications and detailed clinical course around the event onset will aid in comprehensive assessment of the case. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
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| 43 | 2021-01-12 | feeling hot |
heart is racing; face felt hot; irregular heartbeat; This is a spontaneous report from a contactable...
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heart is racing; face felt hot; irregular heartbeat; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on the left shoulder on 06Jan2021 at a single dose for covid-19 protection. Medical history included with irregular heartbeat (diagnosed years ago). There were no concomitant medications. The patient stated that his heart was racing. He was sleeping and woke up to heart racing 130-140. He had irregular heartbeat and his face felt hot the morning of 07Jan2021. He did not know if it was his heart, nerves or what. was his first dose. He got the vaccine on his job and stated that sometimes his heartrate goes up and down not to this magnitude and not while sleeping. He had asked one of the nurses during vaccination about having irregular heartbeat and taking the vaccine and was told that one could die of much worst than this. Patient wanted to know if he should go to the doctor and what to do. Outcome of the event heart racing was recovering while for face felt hot was recovered on the same day of 07Jan2021, and for the remaining event was unknown. Information on the lot/batch number has been requested.
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| 43 | 2021-01-13 | tenderness |
Lymph nodes on left side are swollen. When extending arm upwards (hand above my head), I can see a ...
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Lymph nodes on left side are swollen. When extending arm upwards (hand above my head), I can see a bump right under my armpit. Bump is probably 3" diameter and approximately .75" in thickness (as thick as my fingers, not as thick as the palm of my hand). It's tender to the touch, but not painful. Lymph nodes on right side do not seem to be affected.
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| 43 | 2021-01-14 | burning sensation |
2nd vaccine on Saturday. Sunday, burning feet, leg, thigh. Went to ER to check if it was cause by ...
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2nd vaccine on Saturday. Sunday, burning feet, leg, thigh. Went to ER to check if it was cause by diabetes, was told its probably not Gulliam Barre. Still having the symptoms. Worsen when laying down, better with movement.
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| 43 | 2021-01-15 | pain in extremity |
started 1.15.21 at midnight-Fever, chills,muscle ache and pain in left arm where vaccine was adminis...
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started 1.15.21 at midnight-Fever, chills,muscle ache and pain in left arm where vaccine was administered. Tylenol taken on 1.15.21
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| 43 | 2021-01-17 | facial paralysis, bell's palsy |
Right side lip paralysis noticed on January 2. It has spread to my face and eye since then. Had k...
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Right side lip paralysis noticed on January 2. It has spread to my face and eye since then. Had knee surgery on December 30.
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| 43 | 2021-01-17 | night sweats |
72 hours of body aches, fatigue, uncontrollable chills, fever and night sweats. Got vaccine 8am an...
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72 hours of body aches, fatigue, uncontrollable chills, fever and night sweats. Got vaccine 8am and symptoms appeared at 4am next morning.
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| 43 | 2021-01-18 | pain in extremity, numbness |
Patient could not open and close hand after the first day of vaccination. On the third day his arm t...
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Patient could not open and close hand after the first day of vaccination. On the third day his arm turned purple and could not be moved and was numb. A week and a half after vaccine, arm hurt and was numb. Patient was hospitalized.
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| 43 | 2021-01-19 | migraine |
Soon after the injection he noted a slight fever, body pain, migraine, slight nausea. These symptoms...
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Soon after the injection he noted a slight fever, body pain, migraine, slight nausea. These symptoms lasted for 2 days
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| 43 | 2021-01-19 | tingling, cold sweat |
A few hours after the shot my hands and feet where tingling and felt clammy/ swollen. After work i ...
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A few hours after the shot my hands and feet where tingling and felt clammy/ swollen. After work i noticed that my heart rate would increase when walking around and that the heart beat felt heavy. If i was lying down the heart rate would be slightly elevated compared to normal resting heart rate. The heart rate beat felt heavy. I went to bed early and slept through the night. I woke up the next morning and felt fatigued, dizzy, slight body ache and nauseated. no fever, no headache. i tried to take a shower but symptoms got worse. i was unable to go to work that day. I took a few naps during the day and by late afternoon most symptoms where going away. the last symptom was the issue with the hands and feet. Heart rate returned to normal. The next day i was able to return to work.
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| 43 | 2021-01-20 | muscle spasms |
Severe right tibialis anterior muscle cramp; low level fever; This is a spontaneous report from a co...
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Severe right tibialis anterior muscle cramp; low level fever; This is a spontaneous report from a contactable physician (patient). This 43-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899 and expiry date unknown, vaccine location: left arm), intramuscular on 05Jan2021 08:00 at a single dose for COVID-19 immunization. Medical history included hypertension. The patient has no known allergies. Concomitant medication included valsartan and loratadine (other medications in two weeks include valsartan and loratadine). The patient took the first dose of bnt162b2 on 16Dec2020 01:00 PM (lot number: EH9899) intramuscular, vaccine location: left arm. The patient experienced severe right tibialis anterior muscle cramp on 06Jan2021 12:00 PM, 30 hours after second injection (as reported) with onset of low level fever. The fever resolved within 2 hours. Muscle cramping persisted for 30 hours with complete resolution. No treatment was received. Outcome of the event low level fever was recovered on 06Jan2021 14:00 and of the event muscle severe right tibialis anterior muscle cramp was recovered on 07Jan2021 18:00. The patient had no COVID prior to vaccination. The patient was not tested for COVID post-vaccination. The patient had no other vaccine in four weeks.
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| 43 | 2021-01-20 | numbness and pain in extremities |
Continued left arm injection site pain, left sided neck neuropathy, and feeling of very mild ache to...
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Continued left arm injection site pain, left sided neck neuropathy, and feeling of very mild ache to the anterior throat (feeling of swelling) but not having short of breath or trouble talking.
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| 43 | 2021-01-21 | feeling hot |
Woke up 0230 with severe chills but skin was hot (according to my wife). After several hours of slee...
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Woke up 0230 with severe chills but skin was hot (according to my wife). After several hours of sleep I got out of bed around 0600 and noticed severe body and joint ache and a headache. Once I began moving around I also noticed I would fatigue very quickly. Reminded me of how one feels when they get a good case of the Flu. As the day progressed all symptoms lessened in severity and I went to bed at about 20% of what I felt that morning. I woke the following morning and felt no residual symptoms.
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| 43 | 2021-01-21 | seizure |
coughing quite a bit; seizure; his whole body feels sore; This is a spontaneous report from a contac...
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coughing quite a bit; seizure; his whole body feels sore; This is a spontaneous report from a contactable consumer (patient's mother). A 43-year-old male patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL3248) in right deltoid, on 11Jan2021 around 10:30, for COVID-19 immunisation. The patient was in high risk group, was living in senior facility and was disabled. Medical history included also ongoing hydrocephalus diagnosed when he was less than a year old, ongoing shunt (the first one when he was 11 months old, has had multiple revisions since then, the last in 2017), vagal nerve stimulator implantation ongoing from 2003 (for epilepsy; has had multiple since then, last one in 2015), ongoing hemiparesis since he was a baby and epilepsy (he was taking epilepsy drugs but it was well controlled). Concomitant medications included oxcarbazepine (TRILEPTAL) ongoing from 2000, at 1800 mg daily (600 mg in the morning and 1200 mg at night), for epilepsy and levetiracetam (KEPPRA XR) ongoing from 2000, at 1500 mg twice daily (in the morning and at night), for epilepsy. He was on prior medications to these, since he was young. Over the years he has changed to newer and better medications. On 11Jan2021 around 8-9 PM the patient experienced seizure. The patient has not had a grand mal seizure in over 5 years. On an unspecified date in Jan2021, after the vaccine, his whole body felt sore. He was unsure if it was from the seizure or the vaccine. The reporter also noticed that the patient had been coughing quite a bit on 12Jan2021 morning. Events outcomes were unknown.
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| 43 | 2021-01-22 | pain in extremity | Arm pain that lasted 3 days, chills and diarrhea that lasted 24 hours, I didn't take any treatment. |
| 43 | 2021-01-24 | tenderness | Lump under right arm with tenderness |
| 43 | 2021-01-24 | tremor |
1/14, 2200 - chills 1/14, 2300 - onset of fever 1/15, 0100 - tremors, chills, fever, onset of headac...
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1/14, 2200 - chills 1/14, 2300 - onset of fever 1/15, 0100 - tremors, chills, fever, onset of headache 1/15, 0300 - peak fever @ 100.7 F (baseline is 96.5) 1/15, 1000 - fever resolved 1/15, 1200 - chills resolved 1/15, 2000 - headache resolved
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| 43 | 2021-01-25 | pain in extremity |
arm pain for 3 days at injection site. Shivers and chills in first 24 hours. Mild fever first 24 hou...
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arm pain for 3 days at injection site. Shivers and chills in first 24 hours. Mild fever first 24 hours Ongoing persistent lymph node inflammation in neck for 7 days and counting
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| 43 | 2021-01-26 | numbness |
numbness in right side of face and right arm; hard time swallowing; felt foggy; dizzy; disoriented; ...
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numbness in right side of face and right arm; hard time swallowing; felt foggy; dizzy; disoriented; This is a spontaneous report from a contactable consumer. A 43-year-old male patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on arm left from 11Jan2021 to 11Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included was reported as none. There were no concomitant medications. The patient states about 24 hours later he felt foggy, disoriented, and dizzy (all three occurred on 12Jan2021), states he then woke up at 3 am this morning and had a lot of numbness on right side of face and arm and had a hard time swallowing (both occurred on 13Jan2021), states a couple hours later he went to hospital, went to ER and had to do an MRI, states the MRI of brain and neck came back clear and checked out, states doctors concluded it was an adverse reaction to vaccination. Outcome of the events was recovered on 13Jan2021. Information on the batch/lot number has been requested.
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| 43 | 2021-01-26 | pain in extremity |
Malaise, nausea, headache, mild fever, arm pain. took one dose of acetaminophin,. Symptoms. have res...
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Malaise, nausea, headache, mild fever, arm pain. took one dose of acetaminophin,. Symptoms. have resolved 01/23/2021
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| 43 | 2021-01-26 | tingling |
Blurred vision/ loss of peripheral vision/ Optical migraine followed by headache 45 minutes after va...
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Blurred vision/ loss of peripheral vision/ Optical migraine followed by headache 45 minutes after vaccine. Some tingling on face and left had Resting to see if it goes away.
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| 43 | 2021-01-31 | numbness, slurring |
face numbness unable to make complete sentences called 911 they thought he was having a stroke disch...
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face numbness unable to make complete sentences called 911 they thought he was having a stroke discharge from the hospital with all bloodwork normal
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| 43 | 2021-01-31 | muscle spasms, pain in extremity, numbness |
5 hours after vaccination: body aches and light headache, left arm soreness, cramps and numbness for...
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5 hours after vaccination: body aches and light headache, left arm soreness, cramps and numbness for 2 days. Feeling well and resolved except arm numbness.
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| 43 | 2021-01-31 | tingling, burning sensation, numbness |
Numbness and tingling in left leg; Numbness and tingling in left leg; burning sensation all over leg...
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Numbness and tingling in left leg; Numbness and tingling in left leg; burning sensation all over leg; unable to walk; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3302 and expiration date not provided), via an unspecified route of administration (right arm) second dose on 09Jan2021 17:15 at single dose for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. Historical vaccine includes BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0140) via an unspecified route of administration (left arm) first dose on 21Dec2020. On 09Jan2021 22:30, the patient experienced Numbness and tingling in left leg, burning sensation all over leg, unable to walk. The patient did not received treatment for the events. The outcome of the events was not recovered.
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| 43 | 2021-02-02 | weakness, pain in extremity | Sore arm, body weakness, fever, chills |
| 43 | 2021-02-02 | discomfort, muscle spasms, tingling, numbness, feeling cold |
I had some sort of reaction. I was glad to get the shot and was not nervous about getting the shot....
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I had some sort of reaction. I was glad to get the shot and was not nervous about getting the shot. 5 minutes after the shot I felt something cold go down my left arm from my shoulder to my hand. A minute or two after that both my hands went numb, then both my arms went numb. I asked others around me if anyone felt anything and everyone else was fine. A minute or two after that both my legs went numb. I started to black out but made it to a chair before this happened, I drank some cold water and felt awake about 5 minutes later. 30 minutes after that i felt comfortable enough to walk. For the rest of the day i felt like i was legally drunk and felt lots of pins and needles on the back of my hands and feet. I did not feel dizzy or nauseous at that time. i also felt a lot of pressure on the inside of my skin all over my body. I've never felt anything like that and it was a bit uncomfortable. The next day i was too dizzy to walk without becoming very nauseous. I still had pins and needles on my feet. i had chills as well which i guess is a good sign. my appetite was fine. i felt clear-headed as well. Two days after the shot i felt slightly dizzy and by the third day i felt fine except for minor muscle cramps all over my body. For the three days after the shot i also had some pretty strong forearm and calf muscle cramps and my arms (biceps and triceps) felt pumped up like i just had a great arm workout, but they weren't swollen at all.
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| 43 | 2021-02-03 | weakness |
Continued total body myalgias; weakness; This is a spontaneous report from a contactable Other Healt...
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Continued total body myalgias; weakness; This is a spontaneous report from a contactable Other Health Professional, the patient. A 43-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3246), via an unspecified route of administration in the left arm on 08Jan2021 at 13:00 PM (at the age of 43-year-old) as a single dose for COVID-19 immunization. Medical history included gastrooesophageal reflux disease. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had sars-cov-2 test on 04Jan2021 which was negative. Concomitant medication taken within two weeks of vaccination included dexlansoprazole (DEXILANT). The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine included Dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EJ1685), left arm on 19Dec2020 for COVID-19 immunization. The patient reported that he continued total body myalgias and weakness 11 days post injection. The events began on 11Jan2021. The events was reported as non serious. The patient did not receive treatment for the events. The clinical outcome of the events continued total body myalgias, and weakness was not recovered. It was also reported that since the vaccination, the patient had been tested for COVID-19.
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| 43 | 2021-02-04 | cold extremities |
Patient had vasovagal syncopal event. This event was not a vaccine side effect but a vasovagal respo...
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Patient had vasovagal syncopal event. This event was not a vaccine side effect but a vasovagal response (previous history of syncope with vaccinations/procedures). Patient received 1st dose of Pfizer vaccine around 11am today. Within 2 minutes of receiving the vaccine, he started to feel dizzy and passed out for around 45 secs. He had cold extremities, looked pale and was sweating. He was immediately transferred from chair to floor and his legs were raised. Cold towel was placed on his head. He regained consciousness but was confused for less than a 1min. Vitals were checked and his BP was 95/50's and HR was around 56. Pulse O2 was 99% during entire event. He was able to converse well after that and was oriented. He informed having anxiety/panic attacks, had taken his medication that morning. He reported similar syncopal episodes in the past. He was monitored in same posture. He was gently hydrated orally with water and soda. He was given sublingual zofran due to nausea and retching. He did not vomit. We continued to monitor his BP on regular intervals. He had slow improvement in BP and after 2 hrs while sitting his BP was 104/65, pulse 56/min (reports being an athlete and previous records show baseline bradycardia). He denied any symptoms and was awake, alert, oriented. As he was not accompanied by anyone, his wife was contacted who came to clinic in 10mins and helped to drive him home. He was transported by wheelchair till entrance of clinic. He reported feeling better and thanked for helping. He does not have any contraindications to receive 2nd dose of vaccine.
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| 43 | 2021-02-06 | tremor |
11/17/20 J&J Ad26.CoV2.S vaccination. The next morning patient began mild achiness & fatigue that ...
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11/17/20 J&J Ad26.CoV2.S vaccination. The next morning patient began mild achiness & fatigue that lasted 48 hours and mild arm pain that lasted 72 hours. severity: Gr 1 1/5/21 Pfizer #1. Sudden onset at 10 hours of shaking chills, temperature 103+, severe myalgias and malaise. Severe for 36 hours. 80% better at 48 hrs; at baseline by 72 hours. 1/26/21 Pfizer #2. 10 hours later again noted shaking chills, temperature >103, severe myalgias and malaise. 1/27 could not work. Worked 1/29 & 1/29 at half capability. 1/30 & 1/31 felt worse with temperature >103 both days. 2/1 had to leave work early; noted multiple aphthous ulcers on palate and tongue. Continued to have myalgias and temperature 102-3 through 2/3; tempera
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| 43 | 2021-02-11 | weakness |
Woke up the next morning feeling a little weak, muscle soreness, and slight sore throat. About 30 mi...
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Woke up the next morning feeling a little weak, muscle soreness, and slight sore throat. About 30 minutes after waking up I passed out and fell while taking a shower. I have no history of passing out for any reason and have had no side effects with any other prior vaccinations.
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| 43 | 2021-02-18 | pain in extremity |
Fever, headache, pain in arm; feeling better by 2/16/21, but still dizzy and fatigued. Now has a sor...
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Fever, headache, pain in arm; feeling better by 2/16/21, but still dizzy and fatigued. Now has a sore and itchy throat and pain has returned. Symptoms are "off and on."
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| 43 | 2021-02-19 | weakness |
Entire body rash for 7 days, started at my neck and then to involve my entire body. Fever 101.8-102...
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Entire body rash for 7 days, started at my neck and then to involve my entire body. Fever 101.8-102.9 for 3 days with 1 gram Tylenol and Benadryl. Weakness for a week, unable to work.
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| 43 | 2021-02-20 | numbness |
Lips went numb, partial tongue numbness, spread to the face, elevated blood pressure 180/130, elevat...
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Lips went numb, partial tongue numbness, spread to the face, elevated blood pressure 180/130, elevated heart rate 131 at its highest.
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| 43 | 2021-02-22 | muscle spasms |
left forearm cramping, progressed to left shoulder and upper back over next week; symptoms have pro...
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left forearm cramping, progressed to left shoulder and upper back over next week; symptoms have progressively worsened since that time
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| 43 | 2021-02-22 | tingling |
Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Hypertension-Medium, ...
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Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Hypertension-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium
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| 43 | 2021-02-23 | numbness, nerve pain, numbness and pain in extremities |
Woke up at 4 am on 01/31/2021 with muffled hearing and numbness on left side of body. BP increased t...
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Woke up at 4 am on 01/31/2021 with muffled hearing and numbness on left side of body. BP increased to 150/100. Vomiting and diarrhea. Went to ER on 02/01/2021 and had MRI of the brain to check for stroke/TIA. Had an EKG and carotid artery scan. All tests came back normal. Continued to have neuropathy only on the left side of the body since 01/31/21. Pain travels from nerve to nerve. Occasional HA with pain only on the left side of the head. Cold tightness in chest. Seen PCP numerous times and had bloodwork done, Symptoms have continued since onset on 01/31/21 with no increase or decrease in severity. PCP has referred him to a neurologist.
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| 43 | 2021-02-28 | bell's palsy | Bell's Palsy |
| 43 | 2021-03-01 | numbness, discomfort |
Numbness on right side of face (same side as shot). Numbness around neck, especially the base of ne...
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Numbness on right side of face (same side as shot). Numbness around neck, especially the base of neck with a "heavy" feeling. No loss of functioning. Improvements seen approximately 20 hours following shot with reduced symptoms in these areas still persisting.
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| 43 | 2021-03-02 | burning sensation |
After about 10 minutes I started feeling weird. I became light headed. Then I felt a burning sensati...
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After about 10 minutes I started feeling weird. I became light headed. Then I felt a burning sensation done both arms and my tounge. My heart was beating fast and I was struggling to get my breathing under control. My throat also got tight or warm and that feeling seem to go down through my chest. The monitor told me to take off my mask and gave me water. Shortly after I started to gag and almost vomited. The monitor checked my blood pressure and it was 180 over 120. I was admitted to the ER. I stayed there for about an 90 minutes as was released as the symptoms seemed to leave. While driving home many of the symptoms resurfaced. When I returned home I took a zyrtec and an anxiety medication. A day after I am light headed and a little nautilus but otherwise ok.
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| 43 | 2021-03-02 | cold sweat |
Patient found on ground by bystander. Patient responsive, alert and oriented. States does not know w...
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Patient found on ground by bystander. Patient responsive, alert and oriented. States does not know what happened. Patient stood and sat in chair. A few seconds later patient had syncopal episode and nursing staff assisted him to the ground. BLS provided, airway maintained. Patient pale, diaphoretic and clammy. BP 110/60, P 51, O2 98%, T 96.3. Monitored until EMS arrived. Paramedics on scene. Vitals BP 89/60, P 67, O2 100%, Blood sugar 81. Patient taken to hospital via ambulance.
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| 43 | 2021-03-02 | feeling cold, pain in extremity |
Day after second vaccine dose, patient began having extreme fatigue, overall body chills on/off thro...
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Day after second vaccine dose, patient began having extreme fatigue, overall body chills on/off throughout every day, joint aches in fingers and ankles, bilateral calf pain, wheezing, heart burn, brain fog, cold feeling in feet. These occur throughout every day, on and off. We are now at week 5.
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| 43 | 2021-03-02 | feeling cold |
felt a little colder than usual; trouble falling asleep; general feeling of malaise; pressure buildi...
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felt a little colder than usual; trouble falling asleep; general feeling of malaise; pressure building in my head and abdomen; pressure building in my head and abdomen; left shoulder became increasing sore over 24 hours; This is a spontaneous report from a contactable consumer reported for himself that: 43-years-old male patient started to receive the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on 16Feb2021 15:45 at single dose at left arm for covid-19 immunisation. The patient previously took the first dose bnt162b2 on 26Jan2021 at 43 years old for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced left shoulder became increasing sore over 24 hours on 16Feb2021 15:45, trouble falling asleep on 17Feb2021 04:00, general feeling of malaise, pressure building in my head and abdomen on 17Feb2021, felt a little colder than usual on 17Feb2021 08:30. No treatment was received for the adverse events. Under the tongue temperature reading was 97.9 (The patient was usually 97.5 with this thermometer) on 17Feb2021. The outcome of events was not recovered. No other vaccine in four weeks; No covid prior vaccination; No covid tested post vaccination Information on the lot/batch number has been requested.
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| 43 | 2021-03-04 | tenderness |
fatigue, low grade fever and chills began ~24 hours after the second shot. ~36 hours after second sh...
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fatigue, low grade fever and chills began ~24 hours after the second shot. ~36 hours after second shot right armpit lymph node was visibly swollen and very tender. Swelling went down over the course of 24 hours and was unnoticeable within 48 hours of appearing.
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| 43 | 2021-03-05 | pain in extremity |
Initially had deltoid pain and swelling for 1 day, improved, then 2 days after vaccine started with ...
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Initially had deltoid pain and swelling for 1 day, improved, then 2 days after vaccine started with swelling and pain over medial elbow. Today still has some swelling in deltoid in addition to pain/swelling in medial elbow. Symptoms also consistent with medial epicondylitis, uncertain if vaccine is contributing.
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| 43 | 2021-03-06 | tingling |
Threw up foam and saliva in middle of night. Felt like I was choking, woke from a sleep coughing and...
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Threw up foam and saliva in middle of night. Felt like I was choking, woke from a sleep coughing and spit up foaming mucus. Right leg was tingling as well.
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| 43 | 2021-03-09 | bell's palsy, facial paralysis |
Headache in back/right of head began on 3/5/2021, on 3/7/21 began experiencing facial paralysis in l...
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Headache in back/right of head began on 3/5/2021, on 3/7/21 began experiencing facial paralysis in lips which progressed to the rest of right side of face. Went to Emergency Department that evening. CT scan was "unremarkable" and blood work was normal. Was diagnosed with Bells Palsy. Prescribed Valtrex and Prednisone. 3/10/2021 still experiencing partial facial paralysis and headache in same location.
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| 43 | 2021-03-10 | weakness |
Narrative: As written per ED notes dated 3/9/2021: This 42-year-old female is here for evaluation ...
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Narrative: As written per ED notes dated 3/9/2021: This 42-year-old female is here for evaluation of increasing nausea and vomiting. The patient has gotten worse the past 24 hours. She got her second COVID-19 shot yesterday here at the VA Medical Center. She is complaining of consistent nausea and vomiting and can't keep any fluids down. She is here for evaluation of possible dehydration and weakness. The patient feels markedly improved after oral Zofran. I counseled her at length about this is a possible intolerance to the second Covid 19 immunization. She will be discharged home with Zofran 4 mg tablets 3 times a day as needed for nausea #20, increase fluids and rest, no work until Thursday, March 11, 2021. First covid19 vaccine: 2/15/2021, no adverse events Second covid19 vaccine 3/18/2021: presented to ED
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| 43 | 2021-03-10 | night sweats, weakness |
Patient experiencing shortness of breath, on Friday 3/5 heart beating real hard, felt weak, fatigue,...
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Patient experiencing shortness of breath, on Friday 3/5 heart beating real hard, felt weak, fatigue, lasted about 15 minutes, called ems went to ed, was given prednisone, calmed down, helped with inflammation but still lethargic, chest pressure, and pain, stomach pain, feels like a weight and pressure in chest, feels like sinus infection in head, mucus in them morning was red and thick, also having night sweats
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| 43 | 2021-03-11 | cold sweat |
Pt. looked pale & sweating, RN asked if he was okay, stated he felt like he was going to pass out. ...
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Pt. looked pale & sweating, RN asked if he was okay, stated he felt like he was going to pass out. Pt clampy and sweating. HR 47, Osat 97%. Pt had difficulty breathing with conversation. @1354 Lowered to the floor to lay flat. 1355 BP 101/62, HR 78, O2Sat 98%. @ 1403 BP 100/68, O2Sat 96%, HR 79, pt sitting. @ 1405 pt states "feels ok now" Sitting on the floor 1410 HR 85, O2Sat 94%, Pt remained talkative, alert & oriented sitting on the floor until 14:32. Pt standing 1433 "feels fine" alert and oriented x 3. Pt discharged 14:42. HR 82, Osat 98%
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| 43 | 2021-03-12 | numbness, facial pain |
Right sided facial pressure, pain and numbness. Ear and Neck pain/pressure. Treatment- pain medicati...
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Right sided facial pressure, pain and numbness. Ear and Neck pain/pressure. Treatment- pain medications and consultation/follow up instructions.
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| 43 | 2021-03-17 | weakness, pain in extremity |
About an hour after getting my first shot i started to have back and leg pain, a headache was develo...
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About an hour after getting my first shot i started to have back and leg pain, a headache was developing. about an two and a half hours I started feeling weak. It was hard for me to lift and carry things, I was getting winded walking across the building and the i would feel a little nauseous but that would go away after standing still for a few minutes.
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| 43 | 2021-03-17 | tremor |
@ 0830, Mr. Started complained of feeling chills, and burry vision. Upon assessment, patient was dia...
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@ 0830, Mr. Started complained of feeling chills, and burry vision. Upon assessment, patient was diaphoresis, minimum tremors, AO x 4 time, place, date and situation. VS taken @ 0830 BP 56/38, HR 65, O2 sat 98%. Patient was offered water to drink and wet towel was applied to front head. Another set of VS was taken @ 0837 with BP 92/50. 911 was called @ 0850 and AMR (department #338) arrived @ 0855. Patient was assessed by medic, 12 leads EKG was done NSR. Patient denied transfer to the hospital. Medic left @0900 after explaining to the patient the risks and need to go to the hospital. Patient called his wife. Wife came at 0903. Patient was assessed, no complains of dizziness, was able to walk steadily, before leaving with wife @ 0905.
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| 43 | 2021-03-20 | muscle spasms, pain in extremity |
I had experience of muscle cramps of left calf muscle in Feb / march and observed 3-4 times over a ...
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I had experience of muscle cramps of left calf muscle in Feb / march and observed 3-4 times over a period of 2 months . I was thinking that could be due to dehydration . On 03/ 14 /21 morning , I got severe left leg pain and could not able to walk. I took pain killers and did not subside and that end up going to hospital emergency . I was diagnosed with 2 blood clots in left leg . I do not have family history of clots nor any h/o major medical issues . All my previous and recent blood reports normal . I am currently in use of blood thinners
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| 43 | 2021-03-22 | pain in extremity |
Day 1 none 3/21/21 at approx 8pm Dizziness Nausea Joint pain Light fever Dehydrated Insomnia 3/22...
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Day 1 none 3/21/21 at approx 8pm Dizziness Nausea Joint pain Light fever Dehydrated Insomnia 3/22/21 all day Joint pain Dizziness Nausea Vertigo Foot pain Insomnia
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| 43 | 2021-03-24 | bell's palsy, facial paralysis |
experiencing facial paralysis in lips which progressed to the rest of right side of face; Bell's Pal...
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experiencing facial paralysis in lips which progressed to the rest of right side of face; Bell's Palsy; Headache in right back portion of head; This is a spontaneous report from a contactable consumer (the patient). A 43-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot #: EN6202) via an unspecified route of administration, in the right arm on 02Mar2021 at 14:30 PM (at the age of 43 years). Medical history included high blood pressure. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication taken within two weeks of vaccination included hydrochlorothiazid. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took ibuprofen and experienced hypersensitivity. It was reported that the patient experienced headache in right back portion of head which started in PM on 05Mar2021. On 07Mar2021 the patient began experiencing facial paralysis in lips which progressed to the rest of right side of face. The patient went to the hospital emergency department. Bloodwork was normal. Computerized tomogram (CT) scan was noted as "unremarkable". He was diagnosed with Bell's Palsy and prescribed Valtrex and Prednisone. On 10Mar2021 he was still experiencing facial paralysis and headache. The clinical outcome of the events was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 43 | 2021-03-24 | flushing |
Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Patie...
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Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Patient experienced syncope briefly he thinks due to sudden drop in blood pressure but recovered within minutes.
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| 43 | 2021-03-24 | migraine |
Experienced two occular migraine events in the past 24 hrs: first at 3 days after first dose, and se...
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Experienced two occular migraine events in the past 24 hrs: first at 3 days after first dose, and second at 4 days after first dose I've had occular migraines in the past, but haven't had one in the past 10 years. I've had two in the last 24 hours. Occular migraine event for me is temporary blindness with floating bright object in line of vision with mild dizziness. Requires about 20 minutes to fully subside.
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| 43 | 2021-03-27 | inability to speak |
Extreme fatigue starting day following the vaccination. Slept for three days nearly continuously. L...
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Extreme fatigue starting day following the vaccination. Slept for three days nearly continuously. Loss of appetite. Did not eat for three days. Decreased cognitive functions. Sweats and chills (sometimes simultaneously)
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| 43 | 2021-03-29 | flushing, tremor, unresponsive to stimuli |
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsiv...
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Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Syncope-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Additional Details: Bradycardia
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| 43 | 2021-03-30 | hot flush |
report hot flush w/ light headedness. Had observer summons medical help. reported never doing wel...
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report hot flush w/ light headedness. Had observer summons medical help. reported never doing well w/ needles. TX -reclined car seat. removed mask- fresh air; emotional mask- fresh air; emotional support & water. increased wait time. Symptoms resolved / abted. pt. drove off lot after 15 mins. wait time.
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| 43 | 2021-03-30 | muscle spasms |
Patient reports he has noticed over the past week increased shortness of breath on exertion--at base...
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Patient reports he has noticed over the past week increased shortness of breath on exertion--at baseline able to exercise with walking 45-60 minutes without dyspnea, however noticed over the last week getting some shortness of breath even walking to the garage. No chest pain, no fevers, chills, cough. He saw his PCP for these symptoms who ordered EKG and CXR 1 day PTA which per patient were normal--plan was for referral to cardiologist. However on the morning on presentation around 6:45 AM after taking an elevator for work he began feeling lightheaded and lost consciousness, awakening on the floor. He went home as he was not feeling well however proceeded to have another 2-3 episodes of loss of consciousness at home witnessed by his girlfriend--the later 2 occurred while lying down and were not clearly associated with any presyncopal symptoms.
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| 43 | 2021-03-30 | night sweats |
pneumonia; had an infection; getting really sick; Night sweats to chills; Night sweats to chills; Ve...
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pneumonia; had an infection; getting really sick; Night sweats to chills; Night sweats to chills; Very fatigued; I was running 102-103 fever/very high fever; This is a spontaneous report from a contactable consumer. A 43-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 19Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient took the first dose of the Pfizer vaccine and ended up getting really sick and going into the hospital. They determined he had an infection and pneumonia. Things spiraled in the wrong direction. In the afternoon then by the next morning the patient was quite ill. He was sick for like 15 days. Temps for 102-103F. Night sweats to chills. Very fatigued. He would get better, then sick again, then better again and then ended up in the hospital. The events started on 20Feb2021. The patient was hospitalized for the events pneumonia, infection, and getting really sick from 07Mar2021 to 10Mar2021. The patient underwent lab tests and procedures which included body temperature: 102-103 fahrenheit on an unspecified date, investigation: unknown result on an unspecified date. Therapeutic measures were taken as a result of pneumonia, had an infection, getting really sick, i was quite ill, temps for 102-103f, night sweats to chills, night sweats to chills, very fatigued, i was running 102-103 fever/very high fever. Treatment for severe infection and Pneumonia : the patient had "a lot of injection going in his arm, they gave him fluids they gave medications, they tried to bring the Fever Down, they tried to bring the infection down to help clear out the Pneumonia." The outcome of the events was recovering. Information on the lot/batch number has been requested.
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| 43 | 2021-03-30 | pain in extremity |
Fatigue Soreness in left arm; Fatigue Soreness in left arm; This is a spontaneous report from a cont...
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Fatigue Soreness in left arm; Fatigue Soreness in left arm; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248) via an unspecified route of administration in the left arm on 02Feb2021 at 06:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension. The patient had no known allergies. The patient concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unspecified date in Feb2021, the patient experienced fatigue soreness in left arm. The patient did not receive any treatment for the events. The outcome of the events was recovering.
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| 43 | 2021-03-30 | tingling, numbness |
Hearing a high pitch noise in my head that will not go away. Pointer finger on left arm is numb an...
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Hearing a high pitch noise in my head that will not go away. Pointer finger on left arm is numb and tingles with movement or touch. Both symptoms started on the afternoon of the 21st. Both came on at the same time and were very noticeable together.
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| 43 | 2021-03-30 | tingling |
3/31/2021: Patient was observed post COVID-19 immunization for 30 minutes based on pre-vaccination s...
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3/31/2021: Patient was observed post COVID-19 immunization for 30 minutes based on pre-vaccination screening. During the observation period, he experienced an adverse reaction with the following symptoms: Tingling and swelling of face and throat. Tightening sensation to the face including mouth. Sweating, with redness to the face. Mild nonproductive cough. Assessment : Time of assessment 0932am. Alert and oriented. Nurse assessed lung sounds, VS monitored for 30 minutes. Actions taken: assessment of face and mouth, no swelling seen, face is red and he has sweating forehead. Vitals sign taken at 0932 with BP- 185/131, P- 89. R-17 O2- 98% , Benadryl 12.5 mg liquid given po x 1, VS rechecked at 0937, BP - 190/134, P- 84, T- 98.4. R- 18, O2- 98%, Benadryl 12.5 liquid given PO at 0927. EMS on site due to another issue, assessed pts lung sounds and assessed for auditory stridor to neck, patient with slight cough, voices that he is feeling some better, he remains sitting in wheelchair. VS at 0947 , BP- 166/127, P- 82. O2- 98%, VS at 1002- BP_ 154/110, P- 85, O2- 96%. Medications administered: Diphenhydramine (Benadryl) 12.5 ml (25 mg) by mouth. Time: 0932 and 0937. Administered by RN. Disposition:Reports swelling to face and mouth has improved, he is advised to follow up with PCP for elevated BP AND SYMPTOMS ASSOCIATED WITH VACCINE/ Immunizations Administered Name Date Dose VIS Date Route Pfizer COVID-19 Vaccine 3/31/2021 9:08 AM 0.3 mL 12/11/2020 Intramuscular
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| 43 | 2021-03-31 | feeling cold, tremor | Shaking - cold, Nauseated, Headache, fatigue |
| 43 | 2021-03-31 | feeling of body temperature change | hot and cold, restless sleep the night of vaccination. Next day felt fatigue, sick |
| 43 | 2021-03-31 | pain in extremity |
I had soreness in the left arm initially. The morning after the vaccine, I woke up feeling sick. M...
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I had soreness in the left arm initially. The morning after the vaccine, I woke up feeling sick. My body was achey and I felt lethargic and flu-like. I did not have fever. This largely cleared up by the evening.
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| 43 | 2021-03-31 | pain in extremity | 102 FEVER, HEADACHE, CHILLS, ARM SORENESS, BODY ACHES FOR 30 HOURS |
| 43 | 2021-04-01 | weakness |
Upon presentation to Tent 4, participant identified himself as being, "a big baby when it comes to n...
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Upon presentation to Tent 4, participant identified himself as being, "a big baby when it comes to needles". Received vaccine to LUE and was waiting in Obs area with son (who reported only being seated for approx 5 mins.). A loud noise was heard and participant was observed laying out prone on the floor. Clinicians assisted him to roll over where his eyes were red, wide-open gaze, and diaphoretic but was not responding to commands. After turning him to his Rgt side he began to sit up and became slightly combative and was able to be calmed down. Moved to Tent 6 to cot via wheelchair where is RUE BP was 180/100 at 11:09, and Lft radial pulse taken by MD was "60 and weak", Resp 16 and unlabored so no oxygen in use but nearby. Upon further assessment, participant repeatedly stated that, "he just did not feel well" and when probed, c/o frontal headache, nauseated (but did not vomit), and weak. Offered water to sip and by now lip no longer bleeding. When asked, "what did you feel prior to falling out of your seat?", he stated, "I just remember that you all were around me asking me questions...hence could not recall moments leading up to being found on the floor and no type of aura was identified as well. Reported a h/o HTN but did not take his medication today...other history is unremarkable. Ambulance arrival approx 11:13, VS taken, assessed and transported to nearest facility. Family returned and later reported that he sustained only a large "goose-egg" on the forehead and fat lip but otherwise was treated and released.
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| 43 | 2021-04-01 | migraine |
I got a severe headache/migraine soon after the shot and it lasted for about 72 hours. It did seem w...
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I got a severe headache/migraine soon after the shot and it lasted for about 72 hours. It did seem worse than usual and lasted longer than is typical, but it might have been a coincidence since I do get frequent headaches or might have something to do with the vaccine.
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| 43 | 2021-04-01 | pain in extremity |
Starting at approximately 08:45PM on the night of the shot 03/29 (6 hours after the shot) and persis...
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Starting at approximately 08:45PM on the night of the shot 03/29 (6 hours after the shot) and persisting until about 03/31 between 2am and 4am, I had muscle aches and joint aches with occasional shooting pain in the elbow joints. My arm was also sore. The effect cleared up while sleeping. I had sweated enough to dampen my clothes and sheets. Upon waking, I felt fine.
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| 43 | 2021-04-01 | pain in extremity | SORE ARM, PAIN IN THE LEG, ARMPIT, FATIGUE |
| 43 | 2021-04-02 | pain in extremity |
Severe arm pain, pain level 6, otc pain meds taken (muscle relaxer, Vicodin, Tylenol, ibuprofen all ...
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Severe arm pain, pain level 6, otc pain meds taken (muscle relaxer, Vicodin, Tylenol, ibuprofen all tried) Going on 2 weeks Pain spans from bicep, up to base of skull, down left side of mid back
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| 43 | 2021-04-03 | tremor, unresponsive to stimuli |
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flus...
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Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Medium, Additional Details: After patient had vaccine sat down, then felt light headed and broke out into a sweat. Pulse very shallow = 60bpm. Would get better than worse again. Called emt's, came w/i 15 minutes. Said had high bp, but on no meds. when emt's came he passed out and pulse down to 40bpm, emt's gave epinephrine. pulse back up to 60, put on stretcher, passed out again. Took to local hospital/ER
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| 43 | 2021-04-04 | feeling hot |
A phone call was made to the patient a couple days after his second vaccination and he reported that...
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A phone call was made to the patient a couple days after his second vaccination and he reported that he had experienced feeling hot, nausea and fatigue starting the night of his vaccination.
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| 43 | 2021-04-04 | flushing, cold sweat |
Patient states that his skin is clammy and he feel flushed. Patient was transported to ER by ambul...
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Patient states that his skin is clammy and he feel flushed. Patient was transported to ER by ambulance.
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| 43 | 2021-04-04 | pain in extremity | Pain and swelling in big toe. |
| 43 | 2021-04-04 | tingling |
I?m having severe tingling in both legs both arms and torso along with face. Worried the paresthesia...
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I?m having severe tingling in both legs both arms and torso along with face. Worried the paresthesia is going to turn into Guillan-barre.
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| 43 | 2021-04-06 | discomfort, tenderness |
Next day fatigue, and brain fog. Within 24 hours noticed swollen lymph node in left armpit and tend...
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Next day fatigue, and brain fog. Within 24 hours noticed swollen lymph node in left armpit and tenderness (same side as shot). Swelling about the the size of a fist. 7 days later swelling remains, but reduced by 1/2 the size. Within 48 hours notices pain and swelling lymph node under right collar bone and tenderness (opposite side of shot). Swelling is minimal, but collar bone discomfort. 6 days later since onset and collar bone discomfort remains.
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| 43 | 2021-04-06 | pain in extremity |
After initial soreness wore off, shot arm (left) has been partially disabled from full range of moti...
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After initial soreness wore off, shot arm (left) has been partially disabled from full range of motion. Can't lift arm up high or backwards without extreme pain. Almost feels like a nerve is pinched.
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| 43 | 2021-04-07 | cold sweat |
Reported onset of frontal headache before leaving vaccination observation area on 5 April; headache ...
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Reported onset of frontal headache before leaving vaccination observation area on 5 April; headache later resolved after taking Naproxen and has not returned. Patient also experienced feeling sweaty and clammy evening of vaccine receipt; did not measure temperature; no chills; symptoms did not interfere with sleep and were resolved upon awakening on 6 Apr.. On evening of 5 Apr and on 6 Apr, patient reported generalized achiness diminished after taking Naproxen; aching did not change much between 5 and 6 Apr (no worsening); no joint swelling, warmth, or redness. Also noted "rash" within 2-3 hours of vaccine receipt - not pruritic and only located in antecubital area of left (vaccinated) arm (review of photo showed round/oval, erythematous patch about 3x3, possibly Herald patch); no significant local vaccination site reaction of left upper extremity or axillary tenderness and swelling. Denied symptoms c/w immediate allergic reaction [any hypersensitivity-related signs or symptoms consistent with urticaria, angioedema, respiratory distress (e.g., wheezing, stridor), or anaphylaxis that occur within four hours following administration On 8 Apr, patient reports all symptoms gone except red area on left antecubital, which seems to be getting better
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| 43 | 2021-04-07 | flushing | Flush, faint, sweaty and pale |
| 43 | 2021-04-07 | numbness |
Numbness on left side, mainly in lips, tongue, face and arm. No treatment sought. Seems to have reso...
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Numbness on left side, mainly in lips, tongue, face and arm. No treatment sought. Seems to have resolved next day.
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| 43 | 2021-04-07 | pain in extremity, weakness |
Tired headache sore arm no energy diarrhea and not sure if this is just a coincidence but my mouth s...
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Tired headache sore arm no energy diarrhea and not sure if this is just a coincidence but my mouth swelling on April 8th about 2 in the morning.
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| 43 | 2021-04-08 | pain in extremity |
vaccine number 2 injection in right arm and complains of pain in left arm. Able to move and feel lef...
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vaccine number 2 injection in right arm and complains of pain in left arm. Able to move and feel left arm.
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| 43 | 2021-04-09 | tingling, numbness |
44 y/o male presents for HA, fast heartbeat and L arm numbness/tingling 10 min. Pt has hypertension...
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44 y/o male presents for HA, fast heartbeat and L arm numbness/tingling 10 min. Pt has hypertension and DM2. BP 178/96, HR 105, o2 98% RA BP 156/85, HR 100, 02 98% RA Pt states he feels better and ready to go.
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| 43 | 2021-04-10 | weakness |
Fever 100.5, chills, shortness of breath, severe muscle and joint aches, weakness. Pain at injection...
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Fever 100.5, chills, shortness of breath, severe muscle and joint aches, weakness. Pain at injection site.Headache.
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| 43 | 2021-04-10 | muscle spasms |
Severe muscle spasms from muscle scarring from an accident 20 years ago. See earlier accident histo...
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Severe muscle spasms from muscle scarring from an accident 20 years ago. See earlier accident history for more details.
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| 43 | 2021-04-10 | pain in extremity, muscle spasms |
The adverse event that led me to fill out this form: Temperature of 99.4, in the evening two days la...
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The adverse event that led me to fill out this form: Temperature of 99.4, in the evening two days later; I measure my temperature daily in the evening and it's usually in the range 97.2-98.3. Temperature was normal the first two evenings. I also checked the following morning (today) and it's normal again. Other adverse events: Ache, soreness, etc in left arm, for about two days. Ache in left wrist, right after the vaccination; I'd had pain there the previous week. Muscle spasms in my left flank, not uncomfortable, just weird; intermittently for the rest of the day.
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| 43 | 2021-04-11 | weakness |
Patient received dose at 1:19pm walked to OBs area, sat in chair. Started texting, noted weakness, ...
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Patient received dose at 1:19pm walked to OBs area, sat in chair. Started texting, noted weakness, c/o sweaty feeling, alerted staff. Placed in WC, back to Med Eval tent where he was diaphoretic, pale. Did not lose consciousness. Patient admits to not eating or drinking today at all, very stressed about vaccine. Drank a bottle of water, and gatorade, fan for air circulation. Patient recovered well on cot in supine position, walked out without incident. Likely vasovagal response without syncope. NP
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| 43 | 2021-04-12 | flushing |
Within 5 min of getting the shot my face became flush. That lasted for about 30 seconds. A few minut...
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Within 5 min of getting the shot my face became flush. That lasted for about 30 seconds. A few minutes later my neck became very itchy. This lasted for maybe a minute or two.. about an hour later my legs became very itchy. This lasted maybe a minute and was immediately followed by my face getting flush again. This also lasted about a minute. Maybe 15 minutes later the same two events repeated in the same order. Both again lasted maybe a minute. During this time there was a little bit of tingling around my lips. This came and went for a few hours. 15 or so minutes after the 2nd round of itchy legs/face flush, my throat became itchy for a couple of minutes. I did go to the urgent care and while was told by that doctor that as all of these had come and gone within a minute or so and that my breathing had not become an issue that I didn't need an epi shot and that I could just go home. I didn't experience any further allergic reactions, just the expected ones.
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| 43 | 2021-04-12 | numbness, feeling hot |
Felt immediate warmth in injection site. Pain at injection site. Warmth spread rapidly up my shoulde...
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Felt immediate warmth in injection site. Pain at injection site. Warmth spread rapidly up my shoulder neck and around the left side of my face. Within another few minutes the warm area became slightly numb. I could move my face and feel my skin but it felt like it had gone asleep. Over the next few hours it spread down my body, only me left side, all the way to my foot. Groin area also felt numb, like when you sit on a bike too long and my penis also felt numb. Called a teledoc service on Monday as this lingered. They told me that if it had not dissapated after 2 days to let them know. Symptoms went away on Wednesday March 31st.
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| 43 | 2021-04-12 | pain in extremity | Sore arm, headache, very tired. No treatment. Started approximately 18 hrs after vaccination. |
| 43 | 2021-04-12 | tingling |
Bilateral arm and feet paresthesias without numbness or muscular weakness that started several days ...
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Bilateral arm and feet paresthesias without numbness or muscular weakness that started several days after initial vaccine. Patient also started taking Xyzal at the same time. We are stopping Xyzal. His neurological and musculoskeletal exam is normal.
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| 43 | 2021-04-12 | throat numbness |
Face swell and eyes swell shut. Huge bumps all over body and face. I took pics. Throat was also f...
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Face swell and eyes swell shut. Huge bumps all over body and face. I took pics. Throat was also feeling numb
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| 43 | 2021-04-13 | cold sweat |
Cold sweats starting Thursday evening, Friday sweating at night, and Saturday morning ~6:00 am with ...
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Cold sweats starting Thursday evening, Friday sweating at night, and Saturday morning ~6:00 am with chest pain and sweats. Pain intensified and brought to Urgent Care at 8 am where an EKG was completed and showed signs of a heart attack. Was rushed to Hospital Emergency room. Admitted and examined. Completed an angiogram and noted that there was a blood clot that appeared to dissolve. Troponin levels were high showing damage to the left artery. Spent the night in the hospital. Prescribed medication for cholesterol, blood thinners, and seeing a cardiologist.
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| 43 | 2021-04-13 | hot flush, feeling cold |
Hot Flashes, Cold Flashes, Fatigue, Muscles Aches, Headache/sharp pain down to right shoulder, diarr...
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Hot Flashes, Cold Flashes, Fatigue, Muscles Aches, Headache/sharp pain down to right shoulder, diarrhea
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| 43 | 2021-04-13 | night sweats, tremor |
Nausea, vomiting, muscle aches, high fever, severe fatigue, chills, night sweats, shaking, funny tas...
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Nausea, vomiting, muscle aches, high fever, severe fatigue, chills, night sweats, shaking, funny taste, weird feeling lips
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| 43 | 2021-04-13 | night sweats |
Vivid Dreams Body felt like I was hit by a truck. Had trouble getting around. Pain and stiffness thr...
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Vivid Dreams Body felt like I was hit by a truck. Had trouble getting around. Pain and stiffness throughout body. This was at 3am At 6am when I woke up, I felt like there was a band around my right calf, and there was shooting pains through my left foot / ankle The second night, I woke up at 3am in a night sweat and feverish. Headache and vivid dreams.
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| 43 | 2021-04-14 | bell's palsy, facial paralysis |
Sunday April 11th around 2 p.m., tongue numbness and pain behind left ear going down the neck Monday...
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Sunday April 11th around 2 p.m., tongue numbness and pain behind left ear going down the neck Monday April 12th 715 a.m. left side of face paralysis Monday April 12th 740 a.m. went to e.r. and went through tests for stroke or bell's palsey and was determined it was bell's palsey, also had a CT scan and was determined to be ok, was prescribed 5 days worth of prednisone and 7 days worth of antiviral valacyclovir
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| 43 | 2021-04-14 | numbness |
43 y/o male, past medical history of Hypertension (untreated) presents with numbness to the left ear...
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43 y/o male, past medical history of Hypertension (untreated) presents with numbness to the left ear, left neck and left upper arm shortly after vaccination. Vaccination site was the left deltoid. NP and Paramedics at side. Negative Stroke Scale. Vitals taken and patient noted to be hypertensive with BPs ranging between 145/94-166/114, all other vitals normal. Advised patient on the need to transport to the ER via Fire Rescue due to symptoms and bps. Fire rescue arrive on scene where patient refused transport. Patient signed our AMA form in addition to Fire Rescues AMA form. Patient left on his own account.----------------------End.
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| 43 | 2021-04-14 | pain in extremity, tingling |
Malaise, sinus congestion, dizziness, mild fever (99.4 degrees F), increasing in severity since waki...
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Malaise, sinus congestion, dizziness, mild fever (99.4 degrees F), increasing in severity since waking at 5:45 am April 15 Sore left arm, including some tingling along left forearm and back of left hand (diminished within a few minutes of waking)
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| 43 | 2021-04-15 | cold sweat |
Patient received COVID19 Pfizer BioNTech vaccination approximately 1:10p. After vaccination administ...
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Patient received COVID19 Pfizer BioNTech vaccination approximately 1:10p. After vaccination administering RPH requested patient wait for 15 minutes prior to leaving. Approximately 1:20p patient began to feel faint - lightheadness, clammy skin, and pale skin. RPH took pulse over 30 second time period and reported HR of 44. Patient was offered water and RPH assisted patient to lay on the floor with legs raised above head. Skin color slowly returned. Pulse was taken again and came back up to the low 90s. Patient laid on floor for 15 minutes prior to being assisted by RPH to sit in chair. Patient then sat in chair for approximately 10 minutes prior to feeling comfortable leaving. EMS was not called to scene. Patient stated that he had not eaten prior to vaccination. RPH counseled patient to eat prior to receiving second vaccine and to inform vaccinator prior to second dose of previous reaction.
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| 43 | 2021-04-15 | pain in extremity | Chills, Arm Pain, Fatigue, Muscle Soreness |
| 43 | 2021-04-18 | bell's palsy | Bells Palsy, onset on 4/17/2021 |
| 43 | 2021-04-18 | muscle spasms |
received vaccine pfizer 4/18 reports cramping to forearms and calves; soreness to neck, shoulders, c...
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received vaccine pfizer 4/18 reports cramping to forearms and calves; soreness to neck, shoulders, chest. Used no meds to Tx. Denies SOB, flutters, palpitations. States his chest discomfort feels like muscle pain after lifting or a rigorous workout rather than cardiac in nature. Referred to ER
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| 43 | 2021-04-18 | tingling, weakness |
Pfizer-BioNTech COVID-19 Vaccine EUA - About 10 minutes after receiving the first dose of the Pfizer...
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Pfizer-BioNTech COVID-19 Vaccine EUA - About 10 minutes after receiving the first dose of the Pfizer COVID-19 vaccine, pt complained of being dizzy and faint. Pt broke out in a sweat and complained of tingling down his left arm (site of administration was left deltoid) and into his fingers. Pt was instructed to lay down on his side and was given an ice pack to apply to his wrist for the sweating. He was also offered water and to call EMS, which was refused. At this time his blood pressure was checked reading, 102/63 pulse 62. Pt continued to be closely monitored for 30 minutes. During this time he was able verbalize symptoms and continued to complain of dizziness and generalized weakness. After 30 minutes pt sat up and waited an additional 15 minutes before he decided to stand up and at that time decided he was fit to leave. Another blood pressure reading was taken 110/64 pulse 67. He stated that a normal blood pressure reading for him was around 135mmHg systolic.
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| 43 | 2021-04-19 | feeling hot, unresponsive to stimuli, seizure |
1110: Alerted that we had a medical patient. 1111: At patient side to find the patient wa slouched ...
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1110: Alerted that we had a medical patient. 1111: At patient side to find the patient wa slouched over and having snoring respiration?s. The patient appeared pale and diaphoretic. 1112: Contacted Safety Supervisor and also contacting 911. 1113: The patient was seated upright to open airway and asked if he could wake up. Patient was breathing on his own, eyes open, but not tracking. The patient was not responding to painful stimuli. 2 person lift assist to get the patient off the chair and laying on the floor. The patient then had seizure like activity, arms clenched at his side. 10 second passed by, the patient having minimal postictal phase, and the patient immediately sat upright, asking what happened. The patient informed mobile crew that he started to feel hot and dizzy before he started to dream. Vitals taken: BP: 110/54, HR: 40, R: 18, SPO2: 99%, CBG: 108. 1116: Patient care transferred to paramedic unit to transport to closest hospital.
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| 43 | 2021-04-19 | pain in extremity |
The same day, I was exhausted. It lasted 2 days. After that, on the 2nd or 3rd day after my shot, my...
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The same day, I was exhausted. It lasted 2 days. After that, on the 2nd or 3rd day after my shot, my right calf began to hurt. I knew it was connected to the vaccine, but I figured it would go away. Once the information came out about blood clots and my calf still hurt and didn't get better, I decided to go and get it checked out.
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| 43 | 2021-04-20 | nerve pain |
extreme fatigue; joint pain; muscle pain; nerve pain; hives; large red skin blotches on arm where va...
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extreme fatigue; joint pain; muscle pain; nerve pain; hives; large red skin blotches on arm where vaccinated; Swelling in limbs; Headache; head pressure; This is a spontaneous report received from a contactable consumer (patient). A 43-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EW6208), in left arm on 18Mar2021 04:30 PM (at the age of 43-year-old) at single dose for COVID-19 immunization. The patient's medical history included post-traumatic stress disorder (PTSD) and seborrhea. No allergies to medications, food, or other products were reported. Prior to vaccination the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported, no other medications were received by the patient within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 18Mar2021 06:30 PM the patient experienced extreme fatigue, joint pain, muscle pain, nerve pain, hives, large red skin blotches on arm where vaccinated, swelling in limbs, headache and head pressure. The events were reported as serious since resulted in disability or permanent damage. The events resulted in doctor or other healthcare professional office/clinic visit. Treatment was received for the adverse event as steroid pills, ibuprofen, aspercreme rubs and ice pack. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was not resolved.
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| 43 | 2021-04-20 | seizure |
Patient given vaccine, was 10 minutes into the waiting period, passed out of his chair, appeared to ...
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Patient given vaccine, was 10 minutes into the waiting period, passed out of his chair, appeared to have a seizure. Myself and the RN on duty giving vaccines provided first aid to make sure breathing, heartbeat, etc. Kept airway open. He came out of it in about 3-4 minutes and was coherent before the paramedics arrived (6-7 minutes) and was conversing with us and the paramedics. They took him to the ambulance to be checked out.
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| 43 | 2021-04-20 | tremor |
Patient while sitting in the post-vaccination area for 15 minutes, started experiencing lightheaded ...
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Patient while sitting in the post-vaccination area for 15 minutes, started experiencing lightheaded and faint when he got up. I instructed the patient to sit back down and he complied. I went to grab the patient water and calm him because he seemed a little anxious and then he started shaking, so we immediately called 911. I tapped him to see if he was okay, and he said yes was okay but really faint and the patient was sweating. I asked if he was having trouble breathing, but he denied. He drank the water and had chocolate and I kept conversing with him to assess for any physical/mental status changes, and during the conversation the patient said he usually feels faint and anxious when he gets blood drawn but did not mention it during the screening because he never has when receiving vaccinations. The patient was appearing to improve, less anxiousness, less sweating, and getting more color back to his face. When the EMS arrived within 5-10 mins, they assessed his vitals which were all normal and the patient requested not to be taken to the hospital. The EMT personnel felt the patient was doing okay and left. I had the patient stay for another 30 minutes to make sure he was remaining okay before he left.
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| 43 | 2021-04-21 | cold sweat, hypersensitivity of all senses |
I awoke at approximately 02:00 of the morning following the second dose, in a cold sweat and shiveri...
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I awoke at approximately 02:00 of the morning following the second dose, in a cold sweat and shivering so hard that I could not move (locked in a fetal position). This lasted about 30 minutes, after which I fell back asleep, exhausted. The next time that I woke up, I was walking into wall between the bedroom and the bathroom (I have no history of sleepwalking). For much of the remainder of the night I experienced multiple episodes of somnambulance, each time awakening when I ran into some object (bathroom counter, television, bookcase). The last time that I woke up, at approximately 07:00, I must have been standing and simply fell over; my head bouncing off the ground is what caused me to wake up. For the entirety of the day after vaccination (04/12/21) I felt as if I had the flu: chills (though no/very mild fever < 99 F) accompanied by shivering, sometimes convulsive; sore muscles; hyperalgesia (light touch perceived as painful); lethargic; strong sense of malaise; loss of appetite. As stated, this lasted for the entire day, through the time that I went to sleep for the night (2300). The next day, 04/13/21 I felt completely back to normal with the exception that some muscles were slightly sore, possibly due to the exercise of an entire day spent shivering.
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| 43 | 2021-04-21 | feeling hot |
The patient was sitting in a chair on the sidewalk. He received the Pfizer vaccine lot # EW0172 exp...
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The patient was sitting in a chair on the sidewalk. He received the Pfizer vaccine lot # EW0172 exp 04/25/2021 in the right arm at 10:40am. At 10:41am the patient said ?my arm feels hot,? as he motioned to his right arm where he received the vaccine. RN checked the patients arm. There was no sign of rash or redness. At 10:42am the patient stated, ?Now my whole body feels hot.? The patient denied feeling dizzy or nauseous. Per RN's assessments, patient was not flushed, no rash was present, skin was dry. Skin appeared appropriate color for race. The patient insisted on standing up but reported feeling ?dizzy? and looked unsteady as soon as he stood up. RN assisted the patient to sit back down. The patient was given a mat to lay down on but he refused to lay down or put his head between his legs. He sat up with his hands in his hands covering his face. Vitals were taken at 10:45am by RN. RR 18 and no signs of respiratory distress, BP 130/82, HR 68 with regular rhythm per palpation. Patient was offered Benadryl but he refused and still refused to lay down. At 10:50am the patient said, ?I feel all better now.? The patient was advised to stay for the remainder of his 30 minute observation period but he refused and walked off with a steady gait.
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| 43 | 2021-04-22 | pain in extremity |
The next day after the second shot, my right foot got acute pain. I had some fatigue on my left fo...
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The next day after the second shot, my right foot got acute pain. I had some fatigue on my left foot on the day I took vaccine and I had got it examined by the doctor, He did. To find any issue on my left foot and suggested it might be a regular sprain. He also examined throughly the right foot and it was perfectly fine in the day time of vaccinations. The pain on right foot joints got so acute that I could not move out of my bed. I waited for two days hoping that the vaccine effect will go in couple of days.but it became unbearable. I saw my pcp and the blood work showed erratic inflammatory markers and unusable high glucose very low platelets and I was given steroid for six days. The inflammation was coming down when I was on med and bed rest, last Saturday my right heel started showing a new and sharp throbbing pain. I went the ortho and they found that possibly my burssaties sack is inflameated. The pain is so unbearable that I am, prescribed some opioid based pain killers, the PCP and hematologists had a discussion , I was told that I may be developing auto immune disorder. I never had a history of ITP. I am still hopi g it is a shock and body will calm down soon but I am on so much in pain and in a small place to get an immediate medical attention is so hard.
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| 43 | 2021-04-22 | sensory loss |
The patient received the injection, was monitored for 15minutes. He returned to his station at work....
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The patient received the injection, was monitored for 15minutes. He returned to his station at work. He had a sensation that he could not get an adequate breath. He says this started about fifteen minutes after the shot and observation had been done. He was assessed at 5:55pm on Friday (4/23/21). The pt had his vitals done at the area of injections. He was found to be stable. The pt walked under his own power to the medic clinic. There he was placed on a stretcher and vitals performed again. He was given a epic-pen injection in the left thigh, per author. This was a 6:35pm, approximately. He had no adverse effects from the epinephrine shot, with vitals still monitored. An ambulance arrived, report given and he was to be taken to the medical center for further observation.
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| 43 | 2021-04-23 | weakness |
Injection site pain Extreme fatigue Muscle and joint pain Earache Fever Chills Nausea Weakness Swoll...
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Injection site pain Extreme fatigue Muscle and joint pain Earache Fever Chills Nausea Weakness Swollen lymph nodes 24 hours of moderate symptoms followed by mild lingering symptoms
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| 43 | 2021-04-23 | burning sensation |
Fever overnight following the second injection. Lymph node swelling on left side of head and neck wa...
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Fever overnight following the second injection. Lymph node swelling on left side of head and neck was noticed the first morning along with a burning sensation along the scalp on the left side of head. Lumps formed under hair line on left side of head by second morning after the shot. Lymph nodes still swollen on left side of head and neck. Lumps on left side of head became tender to the touch by third morning after the shot. Sought help at "On Demand Care" on 10th day after Vaccine was given due to pain. The following issue was addressed by CNP: Herpes zoster without complication. Prescribed: acetaminophen, capsaicin and valACYclovir on April 23, 2021.
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| 43 | 2021-04-23 | flushing |
Post vaccination patient started to feel flushed, light headed and dizzy- Patient skin pale vitals T...
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Post vaccination patient started to feel flushed, light headed and dizzy- Patient skin pale vitals T 98.7, 113/56, HR51, B/S144, 02 96
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| 43 | 2021-04-24 | feeling cold |
Fever, chills, body aches, fatigue, tiredness, injection site soreness, lump feeling like bruise in ...
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Fever, chills, body aches, fatigue, tiredness, injection site soreness, lump feeling like bruise in armpit.
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| 43 | 2021-04-24 | pain in extremity |
myocarditis; severe pain in my left shoulder, radiating down my left arm all the way to my fingertip...
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myocarditis; severe pain in my left shoulder, radiating down my left arm all the way to my fingertips; severe pain in my left shoulder, radiating down my left arm all the way to my fingertips; severe pain in my left shoulder, radiating down my left arm all the way to my fingertips; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration at the age of 43-years-old, administered in Arm Right on 26Mar2021 12:30 (Lot Number: EA8732) as single dose for COVID-19 immunization. Medical history included allergies, asthma, genetic predisposition to heart disease. Concomitant medication included unspecified medications. The patient previously received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration at the age of 43-years-old, administered in Arm Right on 05Mar2021 12:30 (Lot Number: EN6199) as single dose for COVID-19 immunization. The patient reported, "I had severe pain in my left shoulder, radiating down my left arm all the way to my fingertips. The pain was severe enough to be admitted to a hospital, where they performed an angiogram and MRI, resulting in a myocarditis diagnosis. The doctors suspect that these symptoms may have been at least partially triggered by." The patient experienced myocarditis and severe pain in my left shoulder, radiating down my left arm all the way to my fingertips on 28Mar2021 18:00. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. The patient was hospitalized for the events for 3 days. The patient underwent lab tests and procedures which included angiogram: myocarditis diagnosis on 28Mar2021, MRI: myocarditis diagnosis on 28Mar2021, SARS-CoV-2 test: negative on 02Mar2021. Therapeutic measures were taken as a result of the events which included Ibuprofen, Colchicizine, and Metoprolol. The outcome of the events was recovered/resolved with sequel on an unspecified date. No other vaccine in 4 weeks. Not diagnosed with COVID prior vaccination.
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| 43 | 2021-04-24 | seizure |
Patient experienced a seizure resulting in cardiac arrest. Witnesses described patient "began convul...
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Patient experienced a seizure resulting in cardiac arrest. Witnesses described patient "began convulsing and then tipped over". AED applied with no shock advised. Unknown down time prior to initiation of CPR. Rhythm PEA upon arrival of EMS. 7 mins CPR before ROSC obtained. Initial troponin 12. 12 lead EKG without ischemic changes, arrhythmia, etc. Transthoracic echo without regional wall abnormalities or significant findings. CT of head negative for acute intracranial process. No history of seizure, cardiac issues, drug use, etc.
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| 43 | 2021-04-24 | tremor, flushing, unresponsive to stimuli, weakness |
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unrespons...
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Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Medium, Systemic: Shakiness-Mild, Systemic: Weakness-Mild, Additional Details: Patient was coherent after shot sat down passed out. Hit head trauma scrape on head and knees and called ems showed up 5 minutes took pt walking away.
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| 43 | 2021-04-25 | flushing, feeling hot | felt hot, flushed face and felt itchy. Hives on hands. Rash on face and torso. |
| 43 | 2021-04-25 | numbness, tingling, weakness |
Dizziness and weakness, "Numbness and tingling; Hypertoniciy in legs, ringing in ears, riaght hand...
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Dizziness and weakness, "Numbness and tingling; Hypertoniciy in legs, ringing in ears, riaght hand very numb, loss of bladder contorl, basically every MS exacerbation symptom I've ever had showed up simultaneously."
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| 43 | 2021-04-27 | weakness, pain in extremity |
PT called call center 4/28/2021. Verified pt with 2 identifiers. Pt denies emergency s/sx. Pt report...
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PT called call center 4/28/2021. Verified pt with 2 identifiers. Pt denies emergency s/sx. Pt reports he got 1st vaccine Pfizer 4/14/2021 and ili symptoms; sore throat, nasal congestion, left back(pressure pain but not chest pain or SOB per pt) and both legs pain(weakness but pt is able to walk around in his house without difficulties per pt) since Sunday evening 4/25/20201. Pt said his temperature 99F at noon 4/28/21. Pt is taking tylenol, lozenges and resting a lot and it's helpful. Pt scheduled at 8:45 am 4/29/2021 @ urgent care for evaluation. Pt is educated covid vaccine side effect and flu. Pt agreed and verbalized understanding.
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| 43 | 2021-04-27 | pain in extremity |
Sharp, quick pain in L pinky finger, repeating at intervals over the course of the day. Slight L-sid...
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Sharp, quick pain in L pinky finger, repeating at intervals over the course of the day. Slight L-side chest pain.
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| 43 | 2021-04-27 | tremor |
Pt called to c/o adverse effect to pfizer vaccine received at stadium on 4/22/21. Pt said evening of...
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Pt called to c/o adverse effect to pfizer vaccine received at stadium on 4/22/21. Pt said evening of Thursday 4/22/21, he felt tingling on tongue and back of throat. Friday tingling increased and by evening, per pt, increased tingling, shaking of lips, itchiness all over body. Pt called PCP advise nurse and was advised to take benadryl, Per pt, he took benadryl on Friday evening. On Saturday, there was increased tingling and itchiness, took another benadryl and eventually symptoms subsided on Sunday. Pt advised to f/u with PCP.
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| 43 | 2021-04-28 | burning sensation |
Extreme burning sensation on left arm with burning sensation travelling up to left ear Arm was late...
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Extreme burning sensation on left arm with burning sensation travelling up to left ear Arm was later swelling and difficult to clinch fist Tight tension turning arm Arm had a small scratch from a rose thorn later and became very itchy No muscle soreness in arm
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| 43 | 2021-04-28 | discomfort |
Mental and physical fatigue, headache, pain in both jaws and at injection site, sleepless night afte...
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Mental and physical fatigue, headache, pain in both jaws and at injection site, sleepless night after shot due to headache and inability to get comfortable
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| 43 | 2021-04-28 | pain in extremity |
left pinky toe became very sore, deep purple & red during night following vaccine received in the mo...
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left pinky toe became very sore, deep purple & red during night following vaccine received in the morning. Symptoms gradually subsided on their own during the next five days.
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| 43 | 2021-04-28 | seizure |
Seizure; Cardiac arrest; Arrhythmia; Began convulsing and then tipped over; Began convulsing and the...
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Seizure; Cardiac arrest; Arrhythmia; Began convulsing and then tipped over; Began convulsing and then tipped over; 12 lead EKG without ischemic changes, arrhythmia; Febrile 38+; This is a spontaneous report from a contactable other HCP. A 43-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0169) via intramuscular route in arm left on 23Apr2021 at 12:45 as single dose for covid-19 immunisation. Historical Vaccine included first dose of bnt162b2 (Lot Number: EW0150) via intramuscular, administered in arm left on 02Apr2021at 14:15 for covid-19 immunisation. Medical history included obstructive sleep apnea, food allergy and intolerant of peanuts-causes sneezing and there were no concomitant medications. On 23Apr2021 at 18:30 the patient experienced a seizure resulting in cardiac arrest. Witnesses described patient began convulsing and then tipped over. AED applied with no shock advised. Unknown down time prior to initiation of CPR. Rhythm PEA upon arrival of EMS. 7 mins CPR before ROSC obtained. Initial Troponin 12. 12 lead EKG without ischemic changes, arrhythmia, etc. Transthoracic echo without regional wall abnormalities or significant findings. CT of head negative for acute intracranial process. No history of seizure, cardiac issues, drug use, etc. Intubated and sedated. Febrile 38+ on arrival requiring active cooling measures to maintain normothermia. The case classified as serious emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). On 23Apr2021, the patient underwent lab tests and procedures which included body temperature: 38+ on arrival requiring active cooling measures to maintain normothermia, computerised tomogram head: negative for acute intracranial process, echocardiogram: without regional wall abnormalities or significant findings, electrocardiogram: without ischemic changes, arrhythmia, investigation: pea, sars-cov-2 test: negative Nasal Swab and troponin: 12. Treatment received included multiple life support measures, treatment for seizures, etc. No covid prior vaccination. Patient had covid tested post vaccination. No other vaccine in four weeks. The outcome of the events was not recovered.; Sender's Comments: Based on strong temporal association the causal association between the reported events seizure, cardiac arrest, arrhythmia, began convulsing and then tipped over, febrile 38+ and the usage of the vaccine are considered related. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 43 | 2021-04-29 | weakness, unresponsive to stimuli |
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hype...
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Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypertension-Severe, Systemic: Hyperventilation-Medium, Systemic: Tachycardia-Severe, Additional Details: Patient was unconscious for few seconds after the shot administration. he then became conscious but was dizzy, weak, pale. He was given water and sat down for few minutes. we called 911 and he continued to feel weak and dizzy. EMS said he had high blood pressure, high heart rate , they thought he possibly was in cardiac arrest. Patient was taken to the hospital via ambulance
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| 43 | 2021-04-29 | pain in extremity |
Received vaccine on 4/9/21 and had arm pain for 24-48 hours. This morning 4/30/21 started having se...
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Received vaccine on 4/9/21 and had arm pain for 24-48 hours. This morning 4/30/21 started having severe arm pain in left arm constant dull ache and stabbing sensations severe that comes and goes. No redness or swelling today at the site. Reports received first dose on 3/10/21 and 5 days later had bruise for 2 weeks. Spoke with Dr and advised to follow up with PCP.
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| 43 | 2021-04-30 | bell's palsy |
Bells palsey; This is a spontaneous report from a contactable consumer, the patient. A 43-years-old ...
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Bells palsey; This is a spontaneous report from a contactable consumer, the patient. A 43-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in the right arm on 26Mar2021 at 08:15 (Batch/Lot number was not reported) as a single dose (at the age of 43 years-old) for COVID-19 immunisation. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Medical history included high blood pressure from an unknown date and unknown if ongoing and penicillin allergy from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included lisinopril, metoprolol, hydrochlorothiazide, and clarithromycin; all from unknown dates for unknown indications. The patient previously received bnt162b2, dose 1 via an unspecified route of administration, administered in the right arm on 05Mar2021 at 10:15 (Batch/Lot number was not reported) (at the age of 43 Years-old) for COVID-19 immunisation. On 11Apr2021 at 14:00 the patient experienced bells palsey (Bell's palsy). The event resulted in emergency room visit. Therapeutic measures were taken as a result of Bell's palsy and included prednisone and valacyclovir. The clinical outcome of the event Bell's palsy was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.
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| 43 | 2021-04-30 | tingling, numbness |
Loud ringing in ears; numb/tingle in left pointer finger; numb/tingle in left pointer finger; This i...
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Loud ringing in ears; numb/tingle in left pointer finger; numb/tingle in left pointer finger; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EN6204), via an unspecified route of administration in the left arm, on 18Mar2021 at 15:30 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no allergies to medications, food, or other products. The patient did not have any concomitant medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced loud ringing in ears and numb/tingle in left pointer finger on 21Mar2021 at 17:00. The events were reported as non-serious. The clinical outcome of experienced loud ringing in ears and numb/tingle in left pointer finger was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.
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| 43 | 2021-05-03 | weakness |
Day of 2nd dose of vaccine received: mild soreness in shoulder, neck and back, around the area where...
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Day of 2nd dose of vaccine received: mild soreness in shoulder, neck and back, around the area where the shot was given. Day after vaccine: lower than normal energy, but otherwise fine. Two days after vaccine: low energy, body aching, occasional cough. Three days after vaccine: similar symptoms of the previous day. Four days after vaccine: lower energy, body aches, coughing, persistent headache, eyes feeling tired and burning, and congestion starting in my chest, all worsened in the evening. Five days after vaccine: congestion in chest, regular cough, sore throat, runny nose, eyes feeling dry and burning, shortness of breath. Was tested for Covid on the fifth day after the vaccine. Six days after vaccine, chest congestion, coughing, sore throat, runny nose, shortness of breath, and still low energy. Covid test result came back as negative.
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| 43 | 2021-05-04 | bell's palsy |
Bell's palsy; This is a spontaneous report from a contactable consumer, the patient. This 43-year-ol...
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Bell's palsy; This is a spontaneous report from a contactable consumer, the patient. This 43-year-old male patient, height: 66.22 cm & weight: 175 kg, received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734), via an unspecified route of administration in the left arm on 10Apr2021 17:00 (at the age of 43-year-old) as single dose for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not enrolled in the clinical trial. Medical history included LASIK eye surgery. Concomitant medication(s) included prednisolone acetate (manufacturer unknown) and moxifloxacin (manufacturer unknown) both were taken after LASIK eye surgery. On 19Apr2021 12:30, the patient experienced Bell's palsy. The clinical course was described as follows: On 19Apr2021 at 12:30, the patient was eating lunch and he noticed the left side of his face was a little numb. The patient states he thought originally that he might be having an allergic reaction, but he was eating the same food that he always eats so it couldn't have been that and sort of ignored it. About 21:30, 22:00 at night (19Apr2021), he realized in the shower that he could not open his right eye, right eyelid, then his face was numb and he couldn't form his mouth to make a whistle, and he still can't, and he thought he was having a stroke because his face was all messed up. So that's when he went to the emergency room and they did a CAT scan that determined it was not a stroke, it is Bell's Palsy. The patient stated they prescribed him medications to take, and he was not hospitalized and discharged home. The patient stated his eyelids, they don't blink at the same rate and his left eye doesn't close all the way, he had to force it closed and it's very annoying. The patient verified that all his symptoms began on 19Apr2021 at 12:30 and all symptoms have worsened. The patient stated that he is perfectly healthy, not overweight and he's never had it before, and it came right out of the blue. The clinical outcome of the Bell's palsy was not resolved.
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| 43 | 2021-05-06 | seizure |
syncopal episode; mild seizure activity; This is a spontaneous report from a contactable healthcare ...
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syncopal episode; mild seizure activity; This is a spontaneous report from a contactable healthcare professional. A 43-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ew0161) at the age of 43-years-old, intramuscular in left arm on 20Apr2021 at 11:00 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were reported as none. He has no COVID prior to vaccination and denied being allergic to anything. There was no other vaccine in four weeks and no other medications in two weeks. The patient received his first dose of COVID-19 vaccine in a workplace clinic on 20Apr2021 and experienced syncopal episode with mild seizure activity at 11:15, within the 15-minute period post vaccination (as reported). No treatment was given in response to the events. It was unknown if the patient was tested for COVID post vaccination. The outcome of the events was unknown.; Sender's Comments: A contributory role of BNT162B2 to the reported events cannot be fully excluded based on close temporal relationship and lack of alternate explanation at this time. However, the information provided is very limited and does not allow for a complete medical assessment. Case will be reassessed if additional information is received. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 43 | 2021-05-10 | numbness, burning sensation |
Per patient: Patient received vaccine around noon on the 12 of March 2021 at Community Church. Patie...
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Per patient: Patient received vaccine around noon on the 12 of March 2021 at Community Church. Patient states about 10 -12 hrs later, began an adverse cardiac event. Patient states the day before he injured his knee at work and went to ED from an injury the day before. At the ED they gave Fentanyl and he got sick and told the nurse that he was experience chest pain. Felt burning or falling asleep sensation in arm and chest. Told the nurse he felt like he was having a heart attack. They came in ED with crash cart and confirmed that he was having a heart attack while in ED. Transported from church to hospital.
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| 43 | 2021-05-13 | weakness |
Patient developed acute kidney injury 3 days after he received the vaccine. He initially presented ...
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Patient developed acute kidney injury 3 days after he received the vaccine. He initially presented with emesis, myalgias and weakness and then found to have acute renal failure
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| 43 | 2021-05-14 | bell's palsy |
Diagnosed with Bell's Palsy; This is a spontaneous report from a contactable consumer (patient). A 4...
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Diagnosed with Bell's Palsy; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration at the age of 43-year-old administered in left arm on 24Mar2021 18:00 (Lot Number: ER8730) as single dose for covid-19 immunisation. The patient previously took the first dose of BNT162B2 and administered in left arm at the age of 43-year-old on 24Feb2021 18:00 (Lot Number: EL9261) for covid-19 immunisation. Medical history included hypertension. No known allergies. Concomitant medication included bisoprolol fumarate, hydrochlorothiazide (ZIAC). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was diagnosed with bell's palsy on 06May2021 05:00. Event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient did not have Covid prior vaccination and did not have Covid tested post vaccination. Therapeutic measures were taken as a result of diagnosed with bell's palsy as treatment of antiviral and steroids. The outcome of the event was recovering.
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| 43 | 2021-05-18 | hot flush | Severe cough, runny nose, hot flashes, pain in chest |
| 43 | 2021-05-18 | nerve pain |
My memory, my cognitive skills has declined/severe cognitive and neurological decline within a day o...
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My memory, my cognitive skills has declined/severe cognitive and neurological decline within a day or so of getting it; Neurological decline; I haven't been able to walk/can't even walk unassisted; My skin feels like it's on fire all the time; Very bad nerve pain; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8731; Expiration Date: Jul2021), via an unspecified route of administration, administered in arm left on 10Apr2021 at 13:00 (at the age of 43-years-old) as 1st dose, single for COVID-19 immunisation. Medical history included fusion of C-spine, and problems with C spine from an unknown date and unknown if ongoing. Concomitant medication included oxycodone taken for spinal disorder, start and stop dates were not reported. On 11Apr2021, the patient stated, 'I haven't been able to walk, my skin feels like it's on fire all the time, I've got like very bad nerve pain and, my memory, my cognitive skills has declined. I was able to walk and I was functionable before I got the COVID 19 vaccination.' The patient's wife stated, "He was actually admitted in to hospital for 4 days, 2 weeks ago and they did lot of different lab work and medical tests, MRI, CT scans and full blood work as far as the actual individual details of what they ran, it's a long list and I don't have that handy." Further added, "They gave him a lot of new medications to try to treat the burning in the skin and the nerve pain and he is also has now been admitted into an extensive long outpatient recovery program for cognition, we are working with the occupational therapy and his speech therapy." Her husband had only the first Pfizer vaccine and has severe cognitive and neurological decline within a day or so of getting it. He can't even walk unassisted. He's between a walker and a wheelchair right now and cognition is so bad that some days he can't even process how to feed himself. It was reported that the adverse events started on 11Apr2021. The patient was hospitalized for the events from Apr2021 to Apr2021. The patient underwent lab tests and procedures which included blood test, computerised tomogram and magnetic resonance imaging, all with unknown results on Apr2021. Therapeutic measures were taken as a result of my memory, my cognitive skills has declined/severe cognitive and neurological decline within a day or so of getting it, neurological decline and i haven't been able to walk/can't even walk unassisted. The outcome of the events 'My skin feels like it's on fire all the time' and very bad nerve pain was unknown, while of the rest was not recovered.
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| 43 | 2021-05-24 | nerve pain |
Mild case of shingles. Scalp tenderness, small rash around eye. Nerve pain. Antiviral valocyclovi...
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Mild case of shingles. Scalp tenderness, small rash around eye. Nerve pain. Antiviral valocyclovir prescribed 4 days after onset of symptoms. Cleared up after 2 weeks.
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| 43 | 2021-05-25 | hot flush |
Pt. Had glucose level drops. Down into 60's with no previous issue with hypoglycemia, pale skin in f...
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Pt. Had glucose level drops. Down into 60's with no previous issue with hypoglycemia, pale skin in face. Severe fatigue, low blood pressure readings of 112/60 and 110/90. Hot flashes and nausea. Non-coherent with glassy eyes with no awareness. Fluctuations in symptoms and slept for Three days in and out. Pt. Took approx. Three days to feel back to himself.
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| 43 | 2021-05-25 | tingling |
Within 10 min after receiving the first dose of Pfizer Vaccine. Patient started sweating, tingling i...
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Within 10 min after receiving the first dose of Pfizer Vaccine. Patient started sweating, tingling in his hands. His BP was low (98/60) Temp: 96.6.
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| 43 | 2021-05-26 | pain in extremity, tingling |
Three days after my second shot (on 05/03/2021) I started to feel pain in my left arm, tightness in ...
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Three days after my second shot (on 05/03/2021) I started to feel pain in my left arm, tightness in chest, and I became very light headed. I tried to go to shower but I could not walk and laid down. My ears felt very tingly and I thought I was going to pass out but as far as I know, I did not. I went to my primary care doctor and he has me taking baby aspirin daily (in case blood clot) and wanted to see if it got better I am going to follow up with a cardiologist. I've never had a problem with heart before and get an annual physical at work.
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| 43 | 2021-05-28 | pain in extremity |
The events have been injection site pain, arm soreness, headaches, dizziness, nausea, diarrheas, swe...
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The events have been injection site pain, arm soreness, headaches, dizziness, nausea, diarrheas, swelling, and vomits.
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| 43 | 2021-05-30 | pain in extremity |
Upper arm pain and decreased range of motion remaining at 5 weeks post shot. Unable to do typical a...
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Upper arm pain and decreased range of motion remaining at 5 weeks post shot. Unable to do typical activities of daily living as pain is restrictive and severe.
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| 43 | 2021-05-31 | unresponsive to stimuli |
During observation period, patient became unresponsive to verbal and non-verbal cues. Patient had a...
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During observation period, patient became unresponsive to verbal and non-verbal cues. Patient had a briwf period of loss of consciousness less than 5 seconds in length. Patient regained consciousness. EMS called. Patient observed for an extra 10 minutes. Patient returned to homeostasis. Patient left.
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| 43 | 2021-06-01 | muscle twitching |
chest pain made him go to the emergency room because it was too much, it was multiple throughout the...
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chest pain made him go to the emergency room because it was too much, it was multiple throughout the day not just one time; his penis sensations are a lot different; has had a bad headache where it feels like he has vibrating inside of his head, in his chest and in his abdomen; when he falls asleep he wakes up in an hour; getting shocked in the middle of the night when he is sleeping- in his chest and intestines; getting shocked in the middle of the night when he is sleeping- in his chest and intestines; limbs twitch; This is a spontaneous report from a contactable consumer. A 43-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Lot Number: ER8732; Expiration Date: 31Jul2021), 1ST DOSE SINGLE via an unspecified route of administration, administered in Arm Left on 27Mar2021 for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced chest pain made him go to the emergency room because it was too much, it was multiple throughout the day not just one time, has had a bad headache where it feels like he has vibrating inside of his head, in his chest and on 31Mar2021, when he falls asleep he wakes up in an hour 31Mar2021, getting shocked in the middle of the night when he is sleeping- in his chest and intestines on 31Mar2021, getting shocked in the middle of the night when he is sleeping- in his chest and intestines on 31Mar2021, limbs twitch on 31Mar2021, his penis sensations are a lot different. It was reported that 5 days after he got the first dose of the COVID vaccine he started getting pains and the major thing is at night. If he falls asleep, he wakes up in an hour and that has been every night for a month and a half. That is the main thing that is pissing him off. He confirms that he is having issues with his chest and his intestines like he mentioned previously and he has started keeping track and has kept a journal of the pains. This stuff is new. He has never experienced this before and it has been happening every day starting 5 days after when he got the COVID vaccine. He had the COVID vaccine on 27Mar2021 and on 31Mar2021 he got the first shock in his chest at 0120 in the morning when he was sleeping. Then that went on for a week, he had it on 31Mar2021, 01Apr2021, 02Apr2021, 03Apr2021 and 04Apr2021 where he was getting shocked in the middle of the night when he is sleeping. On 04Apr2021 he had to go to the emergency room and have them look at him. But since 31Mar2021 he has been getting up every hour after he falls asleep. This was all worse when it first started because he has never experienced anything like this. The first shock he had was a hard feeling in his chest and then he couldn't go back to sleep. It is so bad. After he went to the emergency room, that is when it started being not as much of a shock pain that woke him up but he was still waking up every hour. The pains are in his upper chest and in his intestines. Also his limbs twitch and he has had a bad headache where it feels like he has vibrating inside of his head, in his chest and in his abdomen. He confirmed that these also began on 31Mar2021 and have been happening whenever they want and he has never experienced all of that before. Never. Everything has all stayed the same. The sad part is that he just thinks that he is getting used to this "new normal" because he is now going on the second month of this and his body is adapting but this is not normal. Also, he guesses that he shouldn't be shy now but the last thing is that his penis sensations are a lot different and he didn't notice until the first time that he was having relations with his wife after the COVID vaccine and it is all different. He noticed and she did too as far as whenever they were trying to have relations. It has been more than once, it has been every time they have tried afterwards. He says his doctor is going to send him to a sleep lab but he wasn't expecting that. He thought that maybe he would need to go somewhere else. But there he will go to sleep and be hooked up and they will read his whole body and tell the reason why he is waking up every hour. The outcome of the event headache, sleep disorder, chest discomfort, muscle twitching was not recovered and penis order, headache was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
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| 43 | 2021-06-01 | pain in extremity, numbness |
On 5/3/2021, patient called hospital call center to report side effects experienced 4/17 from 1st do...
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On 5/3/2021, patient called hospital call center to report side effects experienced 4/17 from 1st dose Pfizer vaccine. Patient denied emergency symptoms at time of call. Patient only wanted to report symptoms experienced in the past. Advised by PCP to report side effects. 3 days after 1st dose Pfizer vaccine on 4/13, patient reported having pain and numbness in both arms and hands, pain in legs after walking and chest pain. Patient states he did not seek emergency attention on 4/17, but later scheduled an appointment with his outside PCP. Patient underwent blood tests and reports being prescribed a stronger dose of Ibuprofen for 2 weeks.
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| 43 | 2021-06-01 | unresponsive to stimuli |
PATIENT DID WELL UPON IMMEDIATE RECEIPT OF VACCINE. MOVED PATIENT TO OBSERVATION AREA. WITHIN 10 MI...
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PATIENT DID WELL UPON IMMEDIATE RECEIPT OF VACCINE. MOVED PATIENT TO OBSERVATION AREA. WITHIN 10 MINUTES PATIENT FAINTED ONTO FLOOR,HIT HEAD AND BECAME NONRESPONSIVE. WE CALLED 911. WITHIN SECONDS HE BECAME RESPONSIVE AND DID NOT WANT EMS TO COME. WE GOT ICE PACKS FOR THE BACK OF HIS NECK AND FOREHEAD AND MADE HIM COMFORTABLE ON THE FLOOR. HE CONTINUED TO SAY HE WAS FEELING BETTER AND THAT IT JUST CAME ON VERY QUICKLY. AFTER 20MINUTES HE WANTED TO SIT UP IN THE CHAIR. AFTER A FEW MINUTES WE MOVED HIM TO A MORE COMFORTABLE CHAIR. PATIENT CONTINUED TO TALK AND RESPOND. AFTER 15 MORE MINUTES HE DECIDED HE WAS GOOD ENOUGH TO LEAVE.
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| 43 | 2021-06-02 | sensory loss |
This is a spontaneous report from a contactable consumer (patient). A 43-years-old male patient rece...
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This is a spontaneous report from a contactable consumer (patient). A 43-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient had dizziness like someone is pushing me off sensation. The outcome of event was unknown. No follow-up attempts are possible; information about lot/batch number cannot been obtained.
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| 43 | 2021-06-06 | tremor, flushing |
Systemic: Abdominal Pain-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Severe, S...
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Systemic: Abdominal Pain-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Severe, Systemic: Diarrhea-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fever-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Medium, Systemic: Nausea-Severe, Systemic: Shakiness-Medium
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| 43 | 2021-06-09 | weakness |
Developed right neck swelling/adenopathy which spread to the left. Significant to impair neck mobil...
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Developed right neck swelling/adenopathy which spread to the left. Significant to impair neck mobility. Developed high fevers roughly 12 hours later with rigors. Was seen in the emergency department. Found to be febrile, significantly tachycardic (sinus) . Was given vancomycin, ceftriaxone empirically. Felt ill for the next 48 hours afterwards with weakness, slow to resolve tachycardia and cough. Neck swelling subsided however, right neck lymphadenopathy persisted for well over a month. Was sent home from ED with Bactrim and keflex for coverage of possible neck cellulitis. However, I do not believe it was a cellulitis. Neck was not tender, not indurated nor erythematous. I am a hospitalist and had colleagues take a look as well.
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| 43 | 2021-06-09 | numbness |
Left foot became swollen the day after first dose then continued to swell with numbness in both fee...
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Left foot became swollen the day after first dose then continued to swell with numbness in both feet then by the 5th day my right foot became extremely swollen and i went to medical center. A rash formed I also on my ankle area . I took pictures if needed. Spent 2 night in observation at hospital. Still have numbness and raised skin on my right toe.
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| 43 | 2021-06-09 | migraine |
Quick onset photo and sound sensitivity, nausea, vomiting on 4/16 from 4/16 through 6/5, continued t...
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Quick onset photo and sound sensitivity, nausea, vomiting on 4/16 from 4/16 through 6/5, continued tinnitus and migraine symptoms (photo sensitivity and sound sensitivity, sinus pressure, intermittent headaches)
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| 44 | 2021-01-05 | numbness | PRESYNCOPE, RIGHT SIDED FACAIL NUMBNESS |
| 44 | 2021-01-05 | nerve pain, numbness |
Brachial neuritis Right side with moderate pain along myotome, anesthesia right medial elbow and for...
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Brachial neuritis Right side with moderate pain along myotome, anesthesia right medial elbow and forearm, and decrease in grip strenth/dexterity digits 3, 4 right hand
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| 44 | 2021-01-06 | tenderness |
Client noticed this afternoon when showering that his left armpit region was swollen approximately t...
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Client noticed this afternoon when showering that his left armpit region was swollen approximately the size of a tennis ball and tender. Client declines any fever, redness, not warm to the touch either. Client states that he thinks it feels like enlarged lymph node
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| 44 | 2021-01-09 | pain in extremity | Myalgia, Arthralgia, Fever, NauseaVomiting, chills, fatigue, , pain arm Narrative: |
| 44 | 2021-01-11 | flushing, discomfort, numbness |
extremely bad dry mouth; lips were going numb; facial numbness; rash from his neck to his nipple lin...
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extremely bad dry mouth; lips were going numb; facial numbness; rash from his neck to his nipple line; BP was 180/110 / BP stayed around 160/100; felt an "amped" feeling; felt flush; uncomfortable; This is a spontaneous report from a contactable healthcare professional. A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown), dose number 1, intramuscularly on 21Dec2020 14:00 at a single dose on the right arm for COVID-19 immunization. Medical history included gluten allergy with causes dermatitis herpetiformis, osteoporosis, and fibromyalgia. The patient previously took Benadryl and experienced allergies. Concomitant medications were not reported. The patient reported that immediately after receiving vaccine on 21Dec2020, he felt an "amped" feeling and felt flush. It was uncomfortable but not alarming at first. About ten minutes after shot, he started to have extremely bad dry mouth. He went back to work, but he went back downstairs after feeling like he was getting seriously ill and his lips were going numb. His BP was 180/110. The facial numbness went away but his BP stayed around 160/100. He was asked to go to ER, but he refused because he would have to pay for it and he was feeling better. He also noticed after going back upstairs that he had a rash from his neck to his nipple line. The doctor asked for Benadryl, but he was not given due to possible Benadryl allergy. He went home and his BP returned to normal 2 hours later. The patient was not diagnosed with COVID-19 prior to vaccination, and was not tested for COVID-19 since the vaccination. The outcome of the events was recovered in 21Dec2020 for blood pressure increased and facial numbness, and recovered on an unspecified date for the other events. Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the BP increased and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including EKG and chemistry panel, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 44 | 2021-01-11 | pain in extremity |
pain in both big toes, severe pain in the left big toe; acute gouty attack; acute gouty attack; This...
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pain in both big toes, severe pain in the left big toe; acute gouty attack; acute gouty attack; This is a spontaneous report from a contactable physician (patient). A 44-year-old male patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular (left arm) on 17Dec2020 15:30 at single dose for Covid-19 immunization. Patient's medical history included gout and shellfish allergy. Concomitant medications included magnesium glycinate (MAGNESIUM GLYCINATE), colecalciferol (VITAMIN D), and finasteride. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported he got his vaccine on 17Dec2020, a week later on 03Jan2021 (04:30 PM) he started having some pain in both big toes and then 3 days ago, he had severe pain in the left big toe with what appears to be acute gouty attack. The patient reported he has a history of gout previously but had controlled it for a long time. There were no other changes that happened. The patient was treated with ibuprofen and colchicine. The outcome of events was recovering. The patient has not been tested for COVID-19 since the vaccination. This case is non-serious.
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| 44 | 2021-01-11 | pain in extremity |
Dizziness-10 min post injection resolved within 60 min, headache-10 min post injection resolved with...
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Dizziness-10 min post injection resolved within 60 min, headache-10 min post injection resolved within 60 min Rash, neck and chest area 50 min post injection resolved with 30 mg Claritin reditabs 90 mins post injection Body ache- few hours post injection resolved in 24 hrs Injection site/arm pain 20 min post injection resolved in 3 days Blood pressure increased to 170/100 30 min post injection resolved 60-90 min
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| 44 | 2021-01-12 | muscle spasms |
Severe epigastric abdominal pain (cramping/boring, radiating to back) with associated nausea and vom...
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Severe epigastric abdominal pain (cramping/boring, radiating to back) with associated nausea and vomiting - 4 hours Fever, chills, myalgia, malaise - 12 hours (treated with acetaminophen)
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| 44 | 2021-01-12 | pain in extremity, night sweats, weakness, flushing |
Arm soreness 1st day, 3pm next day body aches, weakness and fatigue, heavy head, fever 102. Next da...
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Arm soreness 1st day, 3pm next day body aches, weakness and fatigue, heavy head, fever 102. Next day, still experiencing fatigue and body aches but not as much. 1/12/21 feeling flu type symptoms again body aches, muscle, nausea, chills, severe sweating during night sleeping awoke several times . 1/13/2021 feeling flushed and sweating again while working, stomach cramps, nausea and then vomited x1. Tiredness and extreme fatigue, almost hard to walk, heavy head, chills, fever 100. Has taken Tylenol some relief
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| 44 | 2021-01-12 | tingling | Mild Tachycardia, small SOB, diaphoretic for 5 min, digits tingly , very dizzy |
| 44 | 2021-01-13 | cold sweat | Shivers, cold sweats, and body ache. Treatment: none. Outcome: mild improvement |
| 44 | 2021-01-14 | cold sweat |
Symptoms - ? EE reports he woke up with chills and cold sweats, EE reports he didn?t feel like he ha...
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Symptoms - ? EE reports he woke up with chills and cold sweats, EE reports he didn?t feel like he had a fever, but no thermometer at his house. EE reports he bought a thermometer later in the day and temp was 98.7. Friday am, feelings of generalized achiness. Last day of work and shift - ? Monday Home remedies? - rest Any improvement? - mild Recommendation? EE encouraged to take ibuprofen as outlined in the Medical Directive. EE encouraged to continue to monitor his symptoms and to contact the Vaccine support line with additional questions and concerns. EE reports he is not feeling well and is scheduled to work today. EE educated to manage his RTW according to the Illness in the Workplace policy. EE verbalized back understanding and denied further questions at this time.
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| 44 | 2021-01-14 | muscle spasms | vomiting, diarrhea, cramps. called in sick to work. |
| 44 | 2021-01-14 | pain in extremity |
right arm became red and swollen and painful. Right arm redness/rash spread to triceps. Denies treat...
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right arm became red and swollen and painful. Right arm redness/rash spread to triceps. Denies treatment. Patient states that it resolved on 01/14/21.
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| 44 | 2021-01-15 | muscle twitching |
About an hour after the injection, I had muscle twitch around left eye. I asked the coworker if they...
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About an hour after the injection, I had muscle twitch around left eye. I asked the coworker if they could see it and they could. The twitch in that muscle stopped that evening. Both of my eyelids occasionally twitch for the past few days
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| 44 | 2021-01-18 | burning sensation, nerve pain | BURNING, ITCHING, NEURALGIA, SHINGLES. |
| 44 | 2021-01-21 | muscle twitching |
10 min after vaccine-twitch in left calf, quad twitching, bicep, glute--only twitching on left side ...
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10 min after vaccine-twitch in left calf, quad twitching, bicep, glute--only twitching on left side for first 30 min following vaccination Then after 30 minutes it switched to right side twitching (twitching not painful) Employee also had trouble breathing at that moment and was diaphoretic--Rapid Response Called VSS--employee returned to work Two hours later employee experienced diaphoresis, presyncope--went to Emergency Dept at this time--all labs and tests came back WNL 1/7: Fever 100, twitching continues (superficial) 1/7-14-superficial twitching throughout body 1/14-1/15?twitching seems to go deeper--in intestine, deep in LRQ 1/22 still having these twitches (not painful, just disturbing/odd)--Employee estimates these twitches happen 20x an hour
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| 44 | 2021-01-21 | pain in extremity |
About 5 minutes after getting the vaccine injection my heart rate suddenly increased (My heart rate ...
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About 5 minutes after getting the vaccine injection my heart rate suddenly increased (My heart rate went back down to normal about 2 or 3 minutes after it initially increased), I was short of breath, and slightly dizzy. The night of and the next morning after the injection, I have been tired, my left arm of the injection site, left shoulder, and lower back have been aching. The next day after the shot, I have been unusually tired, also.
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| 44 | 2021-01-23 | one side paralysis, tenderness, muscle spasms, numbness |
On same day of the first Pfizer COVID-19 vaccine, patient developed left facial numbness, left arm a...
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On same day of the first Pfizer COVID-19 vaccine, patient developed left facial numbness, left arm and left leg weakness with difficulty negotiating stairs, and left arm > left leg involuntary muscle "spasms." Symptoms have improved, but not totally gone away. Patient also complained of severe "brain fog," and severe left arm tenderness after Pfizer vaccine.
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| 44 | 2021-01-24 | numbness | numbness developed in bilateral cheeks of face and cheeks became red |
| 44 | 2021-01-25 | tingling, cold extremities |
As soon as I received the shot and went into the waiting area, I experienced a tingling sensation do...
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As soon as I received the shot and went into the waiting area, I experienced a tingling sensation down my right arm where the injection was administered. Throughout the 15 minutes the sensation began to radiate throughout my body and extremities. I waited about 20 minutes before deciding to leave the facility and proceed with my afternoon. Once I got home, I experienced chills, which I read on the pamphlet was an expected side effect. Both hands and feet were cold and I put on additional layers and lied on the couch and rested. During that time I began to notice the tingling sensation/paresthesia predominantly in the injected (right) arm, but also sporadically in other parts of my body including thigh (front/back), left arm, elbow, back, torso, neck, head, wrists, buttocks, etc. This sensation continued as I prepared for bed and continues as of this writing. It's difficult to say whether the sensation is getting better or worse, but it is consistent best described as someone pricking you every so often.
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| 44 | 2021-01-26 | weakness |
Elevated blood pressure (180/116 highest recorded); dizziness; weakness lasting several hours; This ...
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Elevated blood pressure (180/116 highest recorded); dizziness; weakness lasting several hours; This is a spontaneous report from a contactable consumer (patient). A 44-years-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the left arm on 20Jan2021 14:15 at single dose for COVID-19 immunisation at Public Health Clinic/Veterans Administration facility. The patient medical history was not reported. Concomitant medication included atorvastatin (LIPITOR), 40 mg daily, butalbital, caffeine, paracetamol (FIORICET). The patient experienced elevated blood pressure (180/116 highest recorded), dizziness and weakness lasting several hours on 20Jan2021 14:30 with outcome of recovering. The events were considered life-threating (immediate risk of death from the event) and resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care visit. No treatment was performed. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination the patient had not been tested for COVID-19. Information on the lot/batch number has been requested.
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| 44 | 2021-01-27 | feeling cold |
At approximately 2 AM, the next day, I started to have uncontrollable chills which results in excess...
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At approximately 2 AM, the next day, I started to have uncontrollable chills which results in excessive chattering of my teeth. I had trouble getting warm and had to utilize multiple blankets to gain heat, which is not normal. I was very warm and most likely developed a fever. I did not eat until 2 PM that day and the started feeling better later that night. I was forced to miss work to recover. I returned to work today, 1/28 but I remain tired and a little lethargic.
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| 44 | 2021-01-27 | muscle twitching, tremor |
Little muscle twitches; felt muscle twitches really deep in his abdomen, almost like in the intestin...
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Little muscle twitches; felt muscle twitches really deep in his abdomen, almost like in the intestines; Low grade fever; Muscle soreness; Muscle tiredness; Hands were a little shaky; Very diaphoretic; This is a spontaneous report from a contactable other Nurse. This 44-year-old Nurse (Patient) reported that he received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown) at single dose for vaccination in Jan2021 around 9:45am. Relevant medical history included ongoing Mild shrimp allergy and ongoing Hypertension. Relevant concomitant drugs included amlodipine at 10 mg once daily for Hypertension since Feb2020 and ongoing. Prior Vaccinations (within 4 weeks): None. Family Medical History Relevant to AE(s) was None. The patient was administered the COVID Vaccine around 9:45am; about 10 minutes later he had onset of little muscle twitches on the left side of his body that started in the calf then the glute, then the quadricep, then the bicep and then just started bouncing around everywhere on left side. Approximately a half an hour after that those little muscle twitches started on the right side of his body. Now the little muscle twitches are just everywhere; his hand, his heel, right now as he is speaking he is having the little muscle twitches in his heel; This event has been ongoing since onset; but changed today around 5:00am when he felt muscle twitches really deep in his abdomen, almost like in the intestines which is probably impossible, but it feels like it is not just muscular now, like it is happening in his intestines which concerns him. The little muscle twitches do not hurt, he thinks that is probably why he has waited a week to call; but the fact that they are ongoing and changed today, worsened is unsettling. He reported since that first dose of COVID Vaccine was administered he has also had low grade fever; muscle soreness; muscle tiredness. He reported that a rapid response team was called immediately because of the initial reaction he had. Later that day his hands were a little shaky, he got very diaphoretic and the nurses on the unit of the hospital said he almost fell which he does not recall at all; in response to those events he was taken to the emergency department where they did a complete workup including labs: Complete Blood Count (CBC), Comprehensive Metabolic Panel (CMP), checked his heart and everything was fine; no notable results from any of those tests. The patient was not admitted to the hospital; under observation in emergency room only. Outcome of events Little muscle twitches, Low grade fever, Muscle soreness and Muscle soreness was not resolved, outcome of other events was unknown. Information about lot/batch number has been requested.
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| 44 | 2021-01-27 | pain in extremity |
Pt reports that from day 7-10 (post vaccine) he had a 'cytokine like response" with redness, swellin...
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Pt reports that from day 7-10 (post vaccine) he had a 'cytokine like response" with redness, swelling and pain extending from left shoulder to under arm and chest area. Did not see PCP. Took OTC analgesic, resoled on day 10 post vaccine the response dissipated.
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| 44 | 2021-01-28 | pain in extremity |
significant sore arm 48 hours body chills lasted 12 hours muscle pain lasted 48 hours headache 24 h...
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significant sore arm 48 hours body chills lasted 12 hours muscle pain lasted 48 hours headache 24 hours sore throat- 3+ days (still experiencing) generalized malaise for 3+ days (still experiencing)
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| 44 | 2021-02-01 | pain in extremity |
woke up next day with "splotches" right side nipple area. Progressed to right under arm & right back...
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woke up next day with "splotches" right side nipple area. Progressed to right under arm & right back area. Itchy & painful. He went to his PCP's office & saw NP. Diagnosed with shingles & started on medication. In process of recovering now.
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| 44 | 2021-02-01 | sciatica | Sciatica with no apparent cause. Patient not injured. |
| 44 | 2021-02-02 | facial paralysis |
bell palsy; Headache; rash; This is a spontaneous report from a contactable consumer (patient) repor...
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bell palsy; Headache; rash; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 44-years-old male patient received the first dose of BNT162B2 via an unspecified route of administration on 15Jan2021 15:30 at single dose in deltoid left for COVID-19 immunisation. Medical history included ongoing hypertension, Lactose intolerance, and lipids were a bit elevated on 14Jan2021. Family history included mother has diabetes and hypertension. The patient was allergic to Olives. There was no other vaccine in four weeks. Concomitant medication included ongoing lisinopril daily for blood pressure, ongoing colecalciferol (VITAMIN D) weekly, ongoing duloxetine to help with the blood pressure control, and ongoing Multivitamins daily. On Friday 15Jan2021 night around 11:00 PM he started experiencing headaches and rash. On Sunday night (17Jan2021) he experienced the bell palsy/Facial Paralysis and went to the ER. For bell palsy, the patient first had a shot of steroid, then was given oral Methylprednisonole and oral Famcyclovir. Treatment also received for headache and rash. He is still taking Still taking Methyl-prednisolone and the Famcyclovir and he will end these medications tomorrow. The patient had blood work on 14Jan2021 with normal result, lipids were a bit elevated. Events outcome was not recovered. The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
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| 44 | 2021-02-02 | pain in extremity | C/O lightheaded, headache, arm soreness, did not eat before taking vaccine |
| 44 | 2021-02-03 | migraine |
Migraine; body aches; a headache; nausea; right ear became clogged, and today he can hardly hear any...
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Migraine; body aches; a headache; nausea; right ear became clogged, and today he can hardly hear anything out of his right ear.; sluggish; kind of tired/felt fatigued; The injection site was sore; This is a spontaneous report from a contactable consumer. This 44-year-old male consumer (Patient) reported that he received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK4176) at single dose for COVID-19 immunisation on 19Jan2021. The vaccination was given at 08:15-08:30. He assumed the anatomical location of administration was the muscle in his left shoulder (left arm). Relevant history included back surgery with nerve impact. He was just a big guy. Family medical history was none. Relevant concomitant drugs included Gabapentin 600 mg due to back surgery with nerve impact for 2 years, and Generic cholesterol medication for High cholesterol for years. The patient received the vaccine on Tuesday morning (19Jan2021). He reported that he was kind of tired and the injection site was sore, but nothing significant. He experienced being tired and fatigued at 20:00 and progressively got worse, by Wednesday (20Jan2021), he was more sluggish. On 20Jan2021, he had a headache, nausea and body aches at 10:00. In the evening, his right ear became clogged/"clouded" or muffled, and on 21Jan2021 he could hardly hear anything out of his right ear at 17:00- 18:00. The tiredness got significantly worse on Wednesday, but it had improved on 21Jan2021. The headache lasted about 12 hours, but it was better. The nausea also started with the headache. It was persisting, but mild. The body aches progressively got worse and were gone at the reporting time. He took Treximet for Migraine around 14:00 on 20Jan2021. NO ER or physician's office required. Depending on what he finds out on 21Jan2021, he will go see someone. The outcome of events Tired and fatigued, Body aches, headache, injection site was sore was Resolving, the outcome of events Nausea, Right ear became clogged and can hardly hear anything out of it was not resolved. The muffled ear maybe even worse on 21Jan2021. The outcome of other events was unknown. There was no additional Vaccines Administered on the Same Date of the Pfizer Suspect. No history of previous immunization with the Pfizer vaccine considered as suspect. Prior Vaccinations (within 4 weeks) was none. Relevant test was none.
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| 44 | 2021-02-04 | feeling of body temperature change | Lost taste Body and joint ache Shivering at first 2 nights Feel cold and hot. |
| 44 | 2021-02-07 | feeling cold |
I have had fever, chills, body aches, congestion, headaches, slight nausea, loss of appetite, almost...
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I have had fever, chills, body aches, congestion, headaches, slight nausea, loss of appetite, almost every day since the injection. I sleep at night, and wake up around 2am with sever chills, take 800mg Ibuprofen, and within an hour my chills break and I start feeling better. The process repeats itself in the afternoon and then again in the evening. I'm constantly tired and fatigued, and have been unable to exercise or work out since. I'm still experiencing the symptoms as of today.
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| 44 | 2021-02-07 | tingling |
Tingley feet; light headed; This is a spontaneous report from a contactable Other Health Professiona...
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Tingley feet; light headed; This is a spontaneous report from a contactable Other Health Professional reported for himself. This 44-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at right arm on 26Dec2020 09:30 at single dose for COVID-19 immunization. Medical history included asthma. Patient not diagnosed with COVID-19 prior to vaccination. The patient's concomitant medications were not reported. No other vaccines within 4 weeks prior to the COVID. The patient experienced tingley feet and light headed for days after getting the vaccine on 06Jan2021. No treatment received for the adverse event. Events outcome was recovering and reported as non-serious. Patient has not been tested for COVID-19 since the vaccination. Information on the lot/batch number has been requested.
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| 44 | 2021-02-09 | tenderness |
Swelling under right armpit near the pectoralis. Soft and tender to the touch. About the size of a c...
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Swelling under right armpit near the pectoralis. Soft and tender to the touch. About the size of a chicken egg cut in half lengthwise.
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| 44 | 2021-02-10 | weakness |
Twelve hrs. after the second dose on 1/7/2021; I developed fever of 103 with severe chills, headache...
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Twelve hrs. after the second dose on 1/7/2021; I developed fever of 103 with severe chills, headache,bodyaches faligue,nausea,loss of appetite ,joint pain, unable to get out of bed due to weakness. Severe symptoms lasted around 24 hrs , better next day but persisted for another 24 hrs then fatigue lasted another 7-10 days
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| 44 | 2021-02-12 | numbness |
Developed right scapula area pin 2 weeks after first dose. Became severe the day after the 2nd dose....
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Developed right scapula area pin 2 weeks after first dose. Became severe the day after the 2nd dose. Then noted right axilla numbness on 1/18/76.
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| 44 | 2021-02-16 | sensory loss |
loss of feeling in legs as well as incoherent behavior; loss of feeling in legs as well as incoheren...
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loss of feeling in legs as well as incoherent behavior; loss of feeling in legs as well as incoherent behavior; Upon a CT scan an aneurysm was discovered that was actively bleedings.; extreme headache/severe headaches; went to ER via ambulance in 31Jan2021 for extreme headache and body lameness; This is a spontaneous report from a contactable Consumer. A 44-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Jan2021 at single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medication included allergy pills. Patient went to emergency room (ER) via ambulance on 31Jan2021 for extreme headache and body lameness, which started on 31Jan2021 22:00. Patient was discharged from ER on 01Feb2021. Patient returned to ER via ambulance on 09Feb2021 due to severe headaches and loss of feeling in legs as well as incoherent behavior. Upon a Computerised tomogram (CT) scan an aneurysm was discovered that was actively bleedings. Patient was transferred to medical center and is currently waiting surgical procedure. Adverse events resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was unknown. Information on the lot/batch number has been requested.
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| 44 | 2021-02-17 | inability to speak | expressive aphasia. Improved without directed therapy |
| 44 | 2021-02-17 | facial paralysis, bell's palsy |
10 days following vaccination with first dose of Pfizer-BioNTech vaccine, individual reported to the...
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10 days following vaccination with first dose of Pfizer-BioNTech vaccine, individual reported to the vaccine clinic that he developed symptoms of Bell's Palsy. Specific symptoms included facial droop and inability to close eye on one side. Individual sought urgent medical treatment and was diagnosed with Bell's Palsy and placed on a course of antiviral and steroids. Individual was advised by outside provider to not receive second dose of vaccine.
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| 44 | 2021-02-17 | facial paralysis |
Patient developed slight droop of the right side of the face 27 days after vaccination. Patient also...
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Patient developed slight droop of the right side of the face 27 days after vaccination. Patient also has some numbness of the right side upper lip. Denies other symptoms.
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| 44 | 2021-02-20 | facial paralysis, weakness |
The night of the injection, I woke up with a 10/10 headache, tinnitus, and shortness of breath. I t...
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The night of the injection, I woke up with a 10/10 headache, tinnitus, and shortness of breath. I thought nothing of the shortness of breath as I am asthmatic. The next couple of days I felt completely drained, fatigued. Ten days later I have partial facial paralysis. I saw the emergency physician at the hospital who prescribed prednisone, acyclovir, over the counter eye drops, and an eye patch to wear at night.
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| 44 | 2021-02-21 | weakness |
The morning after receiving vaccine I worked out lifting weights and jumping rope. After about a ha...
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The morning after receiving vaccine I worked out lifting weights and jumping rope. After about a half hour I suddenly stopped sweating became very chilled (shivering), weak, very nauseous, felt rapid heart rate.
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| 44 | 2021-02-22 | muscle twitching |
Patient states he had vaccination at 1030 today and did not want to wait the recommended observation...
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Patient states he had vaccination at 1030 today and did not want to wait the recommended observation time of 15 minutes in the hospital lobby. He is currently a highway patrol officer. While driving in his patrol car, at 1035, he felt tightness in the back of his neck and tightness to his airway- he described it feeling like someone hit him in the neck. He denied having any trouble breathing. Later, he noted his hand was twitching. 1045, he came back to lobby and made an RN aware who brought him to employee health. He declined to go to ED (I found out later). BP was 153/115 HR 102 initially, no hx of high bp. No noted hives or swelling to face or mouth/tongue or L deltoid region. Pt. denied feeling any itching anywhere. Pt. rested for about 15 minutes on exam table. Re-check of BP was 151/113 HR 84. Pt. states he feels better and feel like that feeling of tightness in his neck is decreasing. Made aware to follow up with PCP regarding BP and giving informational handout regarding blood pressure. RN recommended he go to any ED if he has any trouble breathing, swelling of tongue, etc at any time after he leaves this hospital. Pt. verbalized understanding.
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| 44 | 2021-02-23 | seizure |
Patient had seizure, provider could not find pulse, administered 2 rounds CPR and applied AED, EMS n...
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Patient had seizure, provider could not find pulse, administered 2 rounds CPR and applied AED, EMS notified. Patient alert and awake after 2 rounds CPR and was admitted to hospital.
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| 44 | 2021-02-24 | numbness |
Around 4 hrs after vaccine, he felt down and tired. that night he had worsening flu like symptoms. S...
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Around 4 hrs after vaccine, he felt down and tired. that night he had worsening flu like symptoms. Since the vaccine he endorses having a fever, feeling tired and aches all across the body. He also complains of being dizzy and numbness of both his hand that developed since the vaccine. He has taken tylenol and it resolves all the symptoms, however he says that the symptoms return as soon as the tylenol wares of. Denies constipation, diarrhea, chest pain, SOB but endorses nausea. Suggested to contact PCP and to see a doctor, also advised that if symptoms worsen, he should visit an ED.
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| 44 | 2021-02-25 | burning sensation, electric shock sensation |
On the 8th day after shot I started getting pain under left armpit. The pain became worse over the n...
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On the 8th day after shot I started getting pain under left armpit. The pain became worse over the next several days resulting in what I'd describe as an electrical shock/burning feeling whenever I moved my left arm the wrong way (seemingly pinching the lymph nodes). I'm currently on day 5 of the pain and it's still present although it has lessened on the 5th day. On the 2nd day the pain started to move down from the armpit closer to the pectoral.
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| 44 | 2021-02-26 | tingling, flushing |
My blood pressure shot up to 155/105, I got flush, dizzy and had a headache. I had a tingling sensa...
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My blood pressure shot up to 155/105, I got flush, dizzy and had a headache. I had a tingling sensation around my nose and upper lip. Prior to this, my blood pressure had been in the 120's / 70's. I went to the emergency room and was sent home 4 hours later. I had headaches every day, multiple times a day, for the next 10 days and my blood pressure was fluctuating between 130/90 to 150/99 during that time. On February 25, my blood pressure dropped back down to 123/88 in the morning, but shot back up to 152/93 by the evening. My blood pressure continues to fluctuate from 124/89 to 146/106.
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| 44 | 2021-02-28 | weakness | Nausea Dizziness / lightheaded Weakness Anxiety |
| 44 | 2021-02-28 | tingling, numbness, pain in extremity |
Bilateral lower extremity numbness; Tingling; Foot pain; This is a spontaneous report from a contact...
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Bilateral lower extremity numbness; Tingling; Foot pain; This is a spontaneous report from a contactable nurse (patient). A 44-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685), via an unspecified route of administration on the left arm, on 22Dec2020, at single dose, for covid-19 immunization. The patient has no medical history. Concomitant medication included ibuprofen. The patient received the vaccine on 22Dec2020 at the hospital. The patient was not diagnosed with COVID-19 prior vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 30Dec2020 18:00 sudden onset of bilateral lower extremity numbness, tingling, and foot pain. These continued to present day. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient received gabapentin as treatment for these adverse events. At the time of the report, the patient had not recovered from the adverse events. The patient has not been COVID-tested post-vaccination.
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| 44 | 2021-02-28 | tingling |
Tingling sensation bilateral upper extremities; This is a spontaneous report from a contactable nurs...
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Tingling sensation bilateral upper extremities; This is a spontaneous report from a contactable nurse. A 44-year-old male patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231) on her left arm, via an unspecified route of administration on 12Jan2021 17:45 at a single dose for covid-19 immunization. The patient's medical history was not reported. Concomitant medication included ibuprofen. Historical vaccine included on 22Dec2020 (first dose) and experienced Bilateral lower extremity numbness, Tingling and Foot pain. It was reported that the patient had tingling sensation bilateral upper extremities on 12Jan2021 18:00. Continues to present day. PCP following prescribed gabapentin. The outcome of the event was not recovered.
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| 44 | 2021-03-02 | unresponsive to stimuli, seizure |
Patient received a dose of the Pfizer COVID-19 vaccine. Before he could exit the room to begin the o...
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Patient received a dose of the Pfizer COVID-19 vaccine. Before he could exit the room to begin the observation period, the patient became unconscious and slipped into a seizure. Uncertain if it was hypersentivity coupled with vasovagal response, an epi pen was primed but not administered. The patient was unresponsive for a minute then came out of his apparent seizure
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| 44 | 2021-03-03 | night sweats | Sudden onset of fatigue followed by body aches, chills, fever 102.5F, night sweats, headache |
| 44 | 2021-03-04 | facial paralysis |
Started at 3:30 pm on 2/26/21 with neck tightness and eye pressure. Approximately around 6:30 pm, ex...
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Started at 3:30 pm on 2/26/21 with neck tightness and eye pressure. Approximately around 6:30 pm, experienced lip burning/numbness/swelling and facial swelling and drooping. Went to ER and given IV Benadryl and IV Pepcid. Discharged a few hours later. All symptoms have since resolved.
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| 44 | 2021-03-05 | weakness | Dry mouth, tachycardia, weakness, lightheaded. Cleared by medics. |
| 44 | 2021-03-07 | migraine |
I had four days after the vaccine I got serve migraine headaches. I've never had these in my life, t...
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I had four days after the vaccine I got serve migraine headaches. I've never had these in my life, these headaches lasts two weeks. They would be non-stop unless I took Excedrin. I went to see my PCP and he put me on stronger headache medication but they had no effect on me and went back to Excedrin. He observed me to make sure I was ok and had me take a Covid test to make sure I was ok , test was negative.
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| 44 | 2021-03-07 | muscle twitching | Arm and hand twitchy, extreme fatigue, double vision, mental confusion |
| 44 | 2021-03-07 | pain in extremity |
I have been experiencing extreme pain in both of my arms, starting from my fingers and ending at my ...
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I have been experiencing extreme pain in both of my arms, starting from my fingers and ending at my shoulders. The pain come when I move my arms for more than two minutes at a time. This has never happened to me before until after I had taken the vaccine.
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| 44 | 2021-03-09 | pain in extremity |
sore arm; restlessness; Body aches; chills; fatigue; Swollen lymph node under left clavicle; This is...
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sore arm; restlessness; Body aches; chills; fatigue; Swollen lymph node under left clavicle; This is a spontaneous report from a contactable consumer (reported for himself). A 44-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot no: 9262), on Left Arm via an unspecified route of administration on 26Jan2021 13:30 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously took first dose of PFIZER-BIONTECH COVID-19 VACCINE (Lot no: 3248) on left arm on 07Jan2021 12:00 PM for Covid-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 26Jan2021 10:00 PM No symptoms besides a sore arm and restlessness for first 12 hours. Body aches, chills, fatigue for following 24 hours. Fatigue for an additional 24 hours. Swollen lymph node under left clavicle starting at 36 hours and still present. Outcome of the events was not recovered.
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| 44 | 2021-03-10 | pain in extremity, tingling, muscle twitching |
1) Sharp pain in arm near elbow (left arm) the pain comes and goes. Pain scale 8-9 at times. It has...
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1) Sharp pain in arm near elbow (left arm) the pain comes and goes. Pain scale 8-9 at times. It has woken me up the last two nights. Enough pain I can?t fall back asleep. 2) Tingling in index finger (left) feels like hit funny bone 3) Muscle twitching ? tricep, area underneath arm, upper chest (left side) See phone videos
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| 44 | 2021-03-13 | difficulty speaking | nasal congestion, throat tightness, hoarseness |
| 44 | 2021-03-14 | weakness |
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Patient ...
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Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Patient was feeling paralized. However, we can cleary see the patient moving all his extremities-Mild, Systemic: Headache-Mild, Systemic: Weakness-Mild
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| 44 | 2021-03-14 | numbness, pain in extremity |
sitting in car in 30 min line, got dizzy, thought was because of playing on phone, then mouth went n...
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sitting in car in 30 min line, got dizzy, thought was because of playing on phone, then mouth went numb, tongue swelling and lower jaw numbmess. Notified the MD's taken out of car had BP given claritin was being monitored and BP kept rising given epipen. The epipen helped felt swelling go down started to relax. Taken by ambulance to hospital. Treated with Steroid and benadryl and prevacid. No breathing treatments given epipens there and taken home prescribed. after he went home sore arm, dizzy, tired then symptoms started to come back took steroids and bendadryl which helped the reaction to go away. sx lasted 2-3 days. mild towards the end.
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| 44 | 2021-03-15 | tenderness | two days of left side dull pain and tenderness from the base of my skull to my elbow |
| 44 | 2021-03-16 | pain in extremity | Severe pain in the shoulder, back (shoulder blade), and arm. |
| 44 | 2021-03-18 | weakness |
Five minutes after receiving the vaccination on her left arm, she developed nausea and lightheadedne...
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Five minutes after receiving the vaccination on her left arm, she developed nausea and lightheadedness and weakness. No vomiting or syncope. She was escorted to a private session of the arena and monitored. Her initial blood pressure was 140/80. She was given water to drink and ate an apple.
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| 44 | 2021-03-18 | tingling |
Tongue felt numb -- "Like he burned his tongue" Tingly sensation. At 6 p.m. on 3/19/2021 his tongu...
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Tongue felt numb -- "Like he burned his tongue" Tingly sensation. At 6 p.m. on 3/19/2021 his tongue still feels the same. No swelling in his tongue. Denies other symptoms
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| 44 | 2021-03-18 | tremor |
pt got vaccine and was sitting for observation. Pt thought he was having a panic attack so he put h...
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pt got vaccine and was sitting for observation. Pt thought he was having a panic attack so he put his head between his knees, he fainted, hit is head on the floor, and a witness said he was shaking on the floor. The patient came to quickly and said he passed out due to stomach cramps . EMS was on site and did an evaluation. Pt was given ice for his head and had vitals checked and and EKG done. EMS recommended hospital transport but patient refused.
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| 44 | 2021-03-19 | discomfort | Severe ringing sound in both ears. Feels like head is being squeezed. |
| 44 | 2021-03-21 | numbness |
RACING OR ACCELERATED HEART BEAT EARLY AM LASTING BETWEEN 30-40 MINUTES NUMBNESS OF TONGUE AND FINGE...
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RACING OR ACCELERATED HEART BEAT EARLY AM LASTING BETWEEN 30-40 MINUTES NUMBNESS OF TONGUE AND FINGERS LASTING ABOUT FORTY FIVE MINUTES. SEVERE VERTIGO LASTING AROUND ONE MINUTE PER EPISODE EXPERIENCING FIVE EPISODES SO FAR OCCURRED AFTER FIRST WEEK OF VACCINATION 1ST DOSE.
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| 44 | 2021-03-21 | migraine | tinitus, migraines |
| 44 | 2021-03-22 | weakness, hot flush | Fatigue, weakness, red eye, headache, hot flashes, nausea, stomach pain |
| 44 | 2021-03-22 | bell's palsy | Bell's palsy |
| 44 | 2021-03-23 | numbness |
Left arm pain that starts at the injection site from the second shot and then radiates down the len...
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Left arm pain that starts at the injection site from the second shot and then radiates down the length of the arm to the fingers causes the pinky and ring fingers to go numb . This started about 2-3 weeks after the second vaccination right after the bruise at the injection site resolved. It gets worse if I use the arm a lot . It also hurts if I don't use the arm too but not as frequently. I have demonstrably less strength in the pinky and ring fingers when comparing left to right hand. I went to the doctor and have been referred to a neurologist but the earliest appointment available is in April. No treatment for the pain was initiated until evaluation from the neurologist in April. The pain is getting worse and the numbness in the fingers is getting worse as well as time progresses to the point it is interfering with sleep and normal activities.
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| 44 | 2021-03-24 | burning sensation |
small rashes inner left arm; burning sensation inner left arm; This is a spontaneous report from a c...
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small rashes inner left arm; burning sensation inner left arm; This is a spontaneous report from a contactable healthcare professional (patient). This 44-year-old male patient received dose 1 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE; lot number ENG201) via an unspecified route of administration on 19Feb2021 at 16:30 (at the age of 44-years-old) as a single dose in the left arm for COVID-19 immunization. The patient had no medical history. Prior to the vaccine the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Concomitant medications included fexofenadine (ALLEGRA) from an unknown date for an unknown indication. The patient had no allergies to medications, food, or other products. On the first day (also reported as 12Feb2021) at 18:00, the patient experienced burning sensation on the inner left arm. On the second day, the patient experienced small rashes on the inner left arm but different spots from the first day. The events were reported as non-serious. The patient was not hospitalized for the events and did not receive any treatment for the events. The outcome of burning sensation on the inner left arm and small rashes on the inner left arm were recovering. It was also reported that since the vaccine the patient had not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.
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| 44 | 2021-03-26 | tingling |
Random itching throughout body - started on arms and legs and then was all over body, no hives, no r...
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Random itching throughout body - started on arms and legs and then was all over body, no hives, no rash. Additionally sharp, random pains - feels like pins and needles - started on the next day
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| 44 | 2021-03-29 | unresponsive to stimuli, weakness |
3:03PM: Patient received Pfizer Covid vaccine and went to waiting room for 15-minute observation pe...
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3:03PM: Patient received Pfizer Covid vaccine and went to waiting room for 15-minute observation period 3:17 PM: Nurse Called to waiting room; patient states of warmness and dizziness, alert with eyes half open 3:17 PM: Non-responsive to name; head back and nonresponsive; Eased to floor; remains non- responsive for approximately 22 seconds. Opens eyes and responds to name. 3:18 PM: NP present. Neuro assessment completed. Pt remains alert and responsive, skin warm and moist. B/P 132/78 3:24 PM: Remains alert and oriented; states of feeling better; assisted to sitting position 3:25 PM: B/P 110/62 Pulse remains strong at 68, denies dizziness; placed in chair with supervised presence in waiting room 3:35 PM: Offered juice and granola bar; eating without discomfort 3:40: B/P 112/62, 68 and regular, skin warm and dry; encouraged to find ride home or back to work 3:50 PM: B/P 118/72, pulse 72 and regular, continues to state of feeling weak, oriented and alert 4:08 PM: Walked around waiting room without dizziness or dyspnea. Pulse 78 and regular; B/P 112/62 4:18PM: walking around room without discomfort or change in consciousness; B/P 116/72, pulse is 72 and regular. 4:30 PM: Remains alert, skin warm and dry, Pulse 74 and regular.
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| 44 | 2021-03-30 | weakness |
03-31-2021 COVID-19 PCR POSITIVE, PT REPORTS SINUS PRESSURE, TIRED, DECREASED ENERGY AND LIGHT HEADE...
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03-31-2021 COVID-19 PCR POSITIVE, PT REPORTS SINUS PRESSURE, TIRED, DECREASED ENERGY AND LIGHT HEADED. PT STATES HE COMPLETED THE COVID-19 VACCINE SERIES. PRIME DOSE 12-30-2020 AND BOOSTER DOSE 01-20-2021.
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| 44 | 2021-03-31 | tremor |
Shaking chills for over 12 hours then diminished then came back 2 hours later for another 5 hours. B...
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Shaking chills for over 12 hours then diminished then came back 2 hours later for another 5 hours. Began 9 hours after injection. Rash on both forearms within 4 hours. Headache and body aches same time as chills.
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| 44 | 2021-04-02 | unresponsive to stimuli |
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Det...
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Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient received a pfizer covid19 vaccine and sat on the floor during the monitoring period due to dizziness. Patient was given a bottle of water and reported fainting briefly before resuming consciousness. Patient waited at the pharmacy and was given a protein bar and gatorade to help because he reported not eating or sleeping. Blood pressure was taken and was 155/75 mmHg which then decreased to 119/82 mmHg a few minutes later and then normalized to 121/82 before the patient left. Full recovery
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| 44 | 2021-04-04 | tingling, numbness | numbness and tingling in feet and legs like they are asleep |
| 44 | 2021-04-05 | pain in extremity |
After the shot, which I received on a Saturday, I developed pain and redness in my right leg. Two da...
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After the shot, which I received on a Saturday, I developed pain and redness in my right leg. Two days later, on Monday morning, I contacted my primary care physician's office, who told me to go to the ER to be evaluated for a blood clot. At the ER, they performed a doppler ultrasound on my right leg and found a superficial clot in the greater saphenous vein of my right leg. There was no evidence of a DVT in the right leg.
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| 44 | 2021-04-06 | pain in extremity, muscle spasms, numbness |
With in a few hours of the shot I had pain up and down my right arm, up and down my right side and i...
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With in a few hours of the shot I had pain up and down my right arm, up and down my right side and into my shoulder/ neck. I went to home and had a slight fever with chills and could not sleep that night. I called off from work and stayed home. Over the weekend the pain in my neck. shoulder and arm continued. I went to a chiropractor treatment that Tuesday 3/2/21. He made some adjustments and the shoulder / upper arm still did not feel better. My right arm became more numb and weak on Thursday 3/4/2021 . My wife was sitting next me on our couch when I suddenly had a spasm in the upper arm. The next morning I waking and had even more trouble lifting the arm or moving it. I attempted to suffer through it thinking it would get better. Over that weekend conditions with the arm became even worse and was unable to lift it. I returned to chiropractor. He evaluated me and i described what had happened after the second covid shot. He recommend an MRI and I attempted to contact my PCP. With no answer from the PCP i went to the ED who said My PCP would need to order a MRI. I was then sent to physical therapy and Orthopedics. They ordered an X ray and MRI. Both showed nothing. Still seeing physical therapy with some improvement and movement. Have a EMG scheduled for April 22,2021
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| 44 | 2021-04-06 | pain in extremity |
Mild but constant pain in the opposite arm (right), MIld but constant pain in the area between neck ...
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Mild but constant pain in the opposite arm (right), MIld but constant pain in the area between neck and back. Pain lasted for about week and slowly went away.
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| 44 | 2021-04-06 | seizure |
seizure; I fell of my hight; headache; total amnesia; my waking is wobbly and not steady; This is a ...
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seizure; I fell of my hight; headache; total amnesia; my waking is wobbly and not steady; This is a spontaneous report from a contactable consumer (patient). A 44-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: ER8727) via an unspecified route of administration, administered in Arm Left on 22Mar2021 12:30, at the age of 44-year-old, as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient was not diagnosed with COVID prior to vaccination. Concomitant medications included vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]); colecalciferol (VITAMIN D [COLECALCIFEROL]); fish oil (OMEGA 3 [FISH OIL]). On 23Mar2021, at 03:00 AM, the patient fell off his height and had a seizure. This was his first seizure in his life. The patient was rushed to the ED where a CT of the head and neck was done in Mar2021. The CT did not show any bleeding or fracture. The Neurologist dismissed the patient home and had the patient go back and see him in 2 days. The patient has been complaining of headache and taking Tylenol PRN for it. His walking was wobbly and not steady. The patient had a total amnesia of the accident. The patient did not receive treatment for seizure, fall, total amnesia and walking was wobbly and not steady. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not tested for COVID since the vaccination. Outcome the events was not recovered.
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| 44 | 2021-04-07 | flushing |
Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Sys...
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Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: ANXIETY-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Patient drank water as we talked to him. He started to look and feel better after a few minutes. He was able to hold a steady conversation throughout event. Within 5 minutes of being notified of event, patient was scrolling through his phone with no difficulty. We made patient wait for 20 additional minutes while monitoring him and patient stated \"I feel back to normal\" before leaving.
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| 44 | 2021-04-10 | tremor, inability to speak, weakness, seizure |
He had his first vaccine March 19th, 2021 at 12:15, same lot as above, and 24 hours later he had dif...
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He had his first vaccine March 19th, 2021 at 12:15, same lot as above, and 24 hours later he had difficulty breathing, shortness of breath, fatigue, shakes, chills and feeling of weakness/dizziness. It lasted a few days. Then, April 9, 2021, he received his second Covid19 Pfizer shot, same lot at 12:15 pm and the next morning, Saturday, April 10th around 9 am Ira felt the same symptoms from shot 1, but more intense. He was feeling weak, had chills, shakes, profuse sweating, difficulty breathing, shortness of breath, dizziness and vomiting. He was unable to keep water down and stayed in bed. A little after 12pm, he complained of difficulty breathing and possibly not getting enough oxygen so I grabbed my equipment (since I'm a CNA) and checked his vitals. His B/P was very high ( 166/107), no fever (96.7), pulse was normal 72, and low respiration but oxygen was above 90. He said he needed to use the bathroom, I suggested using his urinal but he said he needed to have a bowel movement. Once he was in the bathroom, I went downstairs for a glass of water and then suddenly I heard a huge thump. I ran upstairs, knocked on the bathroom-no response but I could hear noises, so I opened the door and I saw he was face down on the floor, head under the bathroom sink counter, blood everywhere, and he was convulsing. I grabbed him immediately and moved him to his side (I had my fitbit on, it said it was 12:30pm), and he kept seizing. He looked discolored almost blueish color. I held him on his side, he vomited, making noises, but unable to speak, continuing to have a seizure. Seizure lasted three minutes. At 12:33pm, once he had calmed, I ran downstairs to find my phone. I was back at his side calling 911 at 12:35. Paramedics arrived 9 minutes later and took him to the hospital. My brother picked me up and took me to the hospital. Once outside his door, I noticed he was finishing taking X-Rays when he suddenly had another seizure.
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| 44 | 2021-04-11 | weakness |
4/9 - No issues 4/10 - Woke up with alternating sweats/chills throughout day. Temp never above 99.6....
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4/9 - No issues 4/10 - Woke up with alternating sweats/chills throughout day. Temp never above 99.6. Slight headache and nausea. No energy at all. Took doses of ibuprofen throughout day. 4/11 - Continued with alternating sweats/chills. Continued taking ibuprofen and generally able to function. 4/12 - Morning of 4/12 similar to 4/11.
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| 44 | 2021-04-11 | bell's palsy, facial paralysis |
Severe headache that started the day after the shot, developed change in taste, neck muscle pain. S...
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Severe headache that started the day after the shot, developed change in taste, neck muscle pain. Symptoms progressed until 4/8/2021 and woke up with left sided facial drooping. He was seen and in the ER and diagnosed with bell's palsy. Was hypertensive 180/110
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| 44 | 2021-04-11 | numbness |
Following injection, patient reported arm and hand numbness and feeling "dizzy" and stated they "Fel...
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Following injection, patient reported arm and hand numbness and feeling "dizzy" and stated they "Felt weird in my head." Patient was given water and noted that they had not eaten anything this morning. Vital signs at 11:30am - Blood pressure :140/80, Heart rate: 80, temperature 99.1, O2 sat: 98% on Room air. EMS was called. Assessed by EMS, vital signs reassessed by RN at 11:43, standing blood pressure: 150/100, heart rate:82, O2 sat: 98%. Patient released by EMS to home with partner driving car. Patient stated "I will be okay"
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| 44 | 2021-04-12 | bell's palsy |
Severe headache the day after the vaccine, followed by a regular headache until present, worsening i...
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Severe headache the day after the vaccine, followed by a regular headache until present, worsening intensity. Then on 4/10/2021, he developed changes on the right side of his face that were diagnosed in ED as Bell's Palsy.
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| 44 | 2021-04-12 | facial paralysis |
Intermittent facial palsy on left cheek, about one inch below the eye; This is a spontaneous report ...
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Intermittent facial palsy on left cheek, about one inch below the eye; This is a spontaneous report received from a contactable consumer (patient). A 44-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number EN6205), via an unspecified route of administration in the left arm on 03Mar2021 16:00 (at the age of 44-years-old) at single dose and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number EB8727), via an unknown route, in the left arm on 25Mar2021 08:00 (at the age of 44-years-old) at single dose for COVID-19 immunization. Medical history included Slight gluten interance. Concomitant medications were not reported. The patient experienced Intermittent facial palsy on left cheek, about one inch below the eye on 04Mar2021 and intensified after second dose. Therapeutic measures were taken as a result of event are not reported. Treatment received was reported as no. The outcome of the event was not recovered.
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| 44 | 2021-04-12 | migraine | severe migraine severe body/joint aches chills |
| 44 | 2021-04-13 | cold sweat | fever, fatigue, headache, nausea, cold sweat |
| 44 | 2021-04-13 | migraine | Bad Migraine with sensory issues - sensitivity to sounds, Trouble sleeping, Acidity, Sweating |
| 44 | 2021-04-13 | seizure |
Patient was seen at Hospital for seizure, fall and head injury. Subsequent workup following transfe...
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Patient was seen at Hospital for seizure, fall and head injury. Subsequent workup following transfer to another hospital revealed L frontal lobe parenchymal hematoma with overlying subarachnoid hemorrhage, no underlying aneurysm or vascular malformation. He had MRI with and without contrast revealing partial occlusion and thrombus of the superior sagittal sinus with adjacent hemorrhage and edema. Treated with heparin, transitioned to coumadin.
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| 44 | 2021-04-13 | tenderness |
Extremely sore back. Soreness is occurring in mid right side of back near ribs. Very minor red ras...
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Extremely sore back. Soreness is occurring in mid right side of back near ribs. Very minor red rash has occurred in this location as well. It is very tender in this spot and has slight ichyness at times.
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| 44 | 2021-04-14 | pain in extremity, weakness |
March 14 2021 - 2 days after first vaccine shot, leg pain, 1-3 days later diagnosed with superficial...
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March 14 2021 - 2 days after first vaccine shot, leg pain, 1-3 days later diagnosed with superficial blood clot in left leg via ultrasound, treated with baby aspirin for 3 days and heat pad, symptoms slowly lessened till 2nd dose of vaccine on April 2nd, after second dose symptoms worsened again, both legs still fatigue very quickly to this day (April 15 2021) when I'm sitting down on chairs, seats etc. April 8 2021, 12:30pm - heart pain for 30 minutes, felt very weak, similar to light heart attack, ER visit later that day couldn't find any explanation
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| 44 | 2021-04-14 | pain in extremity |
Patient c/o shooting pain (8/10 on pain scale) which migrates in location from his posterior shoulde...
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Patient c/o shooting pain (8/10 on pain scale) which migrates in location from his posterior shoulder, his acromion, and his left bicep s/p second COVID injection.
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| 44 | 2021-04-15 | flushing |
As I was administering the vaccine I was discussing with the patient the adverse reactions I wanted ...
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As I was administering the vaccine I was discussing with the patient the adverse reactions I wanted to monitor after the injection. The patient winced as the vaccine was being injected and said it was more painful than the last time he go it. He immediately stated he didn't feel well. I applied a little pressure to the injection site which he said made it feel better but he was starting to feel flushed and faint. I kept the patient in the chair and got him some water. He reported that he had experienced this before with vaccines but it had been a long time. He asked to lay on the floor so we got him into a prone position on the floor on his right side. He laid there for a few minutes then drank some more water and laid back down. After a few more minutes he was ready to sit up. He moved to a chair in our waiting area left when he felt well enough. I called patient 2 hours later to check on himand he reports he is doing fine.
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| 44 | 2021-04-15 | unresponsive to stimuli |
Client got Pfizer COVID vaccine at 1405, started feeling light headed, dizzy, and sweaty with a rapi...
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Client got Pfizer COVID vaccine at 1405, started feeling light headed, dizzy, and sweaty with a rapid pulse at around 1410. Client was unresponsive and out of it like he passed out for a few seconds and came out of it and was coherent and responsive again. Client was safe, with three EMTs and lead nurse alongside him. Vital signs taken at 1414, BP 138/88, O2 99%, and P 80. Client started feeling better, no longer sweaty or dizzy at around 1415. Client informed healthcare staff that he had not eaten or had any water since 0800. Vital signs taken again 1425, BP 140/90, O2 100%, and P 72. Client was stabilized and ambulated out of the facility and driven home by his mother at 1430.
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| 44 | 2021-04-16 | facial pain |
pain in the right TMJ joint But has a sharp pain toward the right forehead, cheek and chin Not a num...
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pain in the right TMJ joint But has a sharp pain toward the right forehead, cheek and chin Not a numbness Just a pain Improves when not chewing and opening jaw, feels fine. No fevers or chills Denies any tooth/gum pains. This occurred after taking the covid pfizer shot, 2nd does, didn't really notice Didn't really notice his face was swollen until today. No heat/itch.
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| 44 | 2021-04-16 | pain in extremity |
Soreness in left arm lasting about 24-28 hours (started around 8PM 4/15/2021) and fading around 10PM...
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Soreness in left arm lasting about 24-28 hours (started around 8PM 4/15/2021) and fading around 10PM 4/16/2021 Fever peaking at 100.3 starting at 4PM 4/16/2021 and lasting until around 12AM 4/16/2021, mild chills Mild body aches during fever in both shoulders, back and neck, gone by 10PM as fever started to recede.
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| 44 | 2021-04-17 | migraine | Extreme fatigue, migraine, fever, chills & nausea. |
| 44 | 2021-04-19 | flushing |
Vaccine administered 13:54, adverse event started 13:55 same day. Patient had syncopy, flushing/swea...
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Vaccine administered 13:54, adverse event started 13:55 same day. Patient had syncopy, flushing/sweating. BP 115/72 -- > 101/67 -- > 110/78, HR 64 -- > 58 -- > 60, O2=100% -> 97% -- > 98%, RR = 16, Temp 95.1F -- > 96.6F -- > 97.3F. At 15:01, Patient stated no longer lightheaded, patient stable, released from vaccination site.
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| 44 | 2021-04-19 | numbness, pain in extremity |
Numbing in left arm, within 5 minutes, that traveled halfway up the left side of my face. Once it fi...
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Numbing in left arm, within 5 minutes, that traveled halfway up the left side of my face. Once it finished traveling, approximately 10 minutes after shot, the taste of metal appeared on the back of my tongue. The numbness passed within 15 minutes of the shot and then pain began radiating from the shot to my elbow every few minutes. I had a feeling that could be best described as inebriation after about 15 minutes and could smell pizza to be specific. There was no pizza around. This went away within about 10 minutes of onset. I slept for about 4 hours, woke up with a headache, and arm pain for 2 days.
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| 44 | 2021-04-19 | muscle spasms, pain in extremity |
Woke up 4/6/21 with minor, dull cramping feeling in my left calf. Pain increased each day and occur...
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Woke up 4/6/21 with minor, dull cramping feeling in my left calf. Pain increased each day and occurred during rest and activity, although walking was the most painful.
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| 44 | 2021-04-20 | cold sweat |
Pt fell out out of chair onto floor. Was pale and clammy. 4:26 BP 89/50, P 83, o2 95% 4:28 BP 91/54...
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Pt fell out out of chair onto floor. Was pale and clammy. 4:26 BP 89/50, P 83, o2 95% 4:28 BP 91/54, P 83, O2 95% 4:31 BP 120/82 4:39 92/62 , BG 113 Vaccine site closed at 5 , Pt had no one to contact for a ride home. Transported to hospital via ambulance for further eval, discharged home from ER.
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| 44 | 2021-04-20 | migraine, tingling |
Woke up with extreme severe migraine dizziness, vertigo nausea and loud tinnitus! Scalp and face ti...
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Woke up with extreme severe migraine dizziness, vertigo nausea and loud tinnitus! Scalp and face tingling. Ear fullness, head pressure, sinus pressure, visual haze, brain fog. Never experienced this in my life! Persisting for weeks and weeks and continues. Still ongoing. Please help!
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| 44 | 2021-04-20 | tingling, numbness, cold sweat |
4/21/2021 was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening ...
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4/21/2021 was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening . During the observation period, he experienced an adverse reaction with the following symptoms: nausea and tingling and numbness to cheeks and tongue/ c/o of tiredness. Assessment : Time of assessment *1634. Alert and oriented, Tachycardia, Pallor, Diaphoretic, Clammy and Nausea. Actions taken: Vitals sign taken VAERS form obtained and completed by RN. Water x 2 and 1 juice, VS taken at 1634- BP- 141/89, P- 110, O2- 98%, 1642, BP- 139/88, P- 102, O2- 100 %, 455pm, BP- 123/78, P- 97, O2- 100%, 514pm, BP- 123/81, P- 100, O2- 100% Medications administered: Loratadine (Claritin) 10 mg by mouth. Time: 1645. Administered by RN. Famotidine (Pepcid) 10 mg by mouth. Time: 1645. Administered by RN. Diphenhydramine (Benadryl) 12.5 ml (25 mg) by mouth. Time: x 2 doses at 1634 and 1645. Administered by RN. Disposition: Reports no further symptoms of adverse reaction after observation for 60 minutes. Discharged home. The Patient was provided with Vaccine Information Sheet and instruction to access the V-Safe system. Wife with patient. Immunizations Administered Name Date Dose VIS Date Route Pfizer COVID-19 Vaccine 4/21/2021 4:16 PM 0.3 mL 2/25/2020 Intramuscular Manufacturer: Pfizer, Inc Lot: ER8735 NDC: 59267-1000-2 Electronically signed at 4/21/2021 5:33 PM Immunization on 4/21/2021 Detailed Report Note shared with patient
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| 44 | 2021-04-21 | weakness, seizure |
Pt became diaphoretic and light-headed 5 minutes after vaccine was administered. He requested water...
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Pt became diaphoretic and light-headed 5 minutes after vaccine was administered. He requested water and as I was giving it to him he started to pass out. He was conscious but slightly convulsing. He appeared to have a minor seizure for approximately 5-10 seconds. He was transferred to a wheelchair and sent into our recovery room. As we were transporting him, he had two episodes of vomiting and continued to feel diaphoretic and weak. He rested laying down but was not feeling better. He could not tolerate any water or juice.
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| 44 | 2021-04-21 | pain in extremity, unresponsive to stimuli |
Pharmacy was contacted by an aunt, who is also a healthcare provider. This contact was requested by ...
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Pharmacy was contacted by an aunt, who is also a healthcare provider. This contact was requested by the family. Per nurse practitionar who is the aunt of the deceased), patient passed away on Monday, 4/19/2021. He was found unresponsive on a jogging trail, where he had been jogging, by a third party person. They had called an ambulance and could not revive him. Family requested a VAERS report due to the proximity in time to his 2nd Pfizer vaccination. He had received his vaccination at 9:56am on 4/14/21 (lot ER8730) and per father the only side effect he indicated was a sore arm. Autopsy pending per family.
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| 44 | 2021-04-21 | pain in extremity |
Patient presents to the ED with chief complaint of swollen lymph nodes in the area of the left clavi...
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Patient presents to the ED with chief complaint of swollen lymph nodes in the area of the left clavicle with pain radiating down his left arm.
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| 44 | 2021-04-21 | tingling |
Site: Itching at Injection Site-Mild, Systemic: Complained of \" tingling all over \" at 5:25 PM-Mil...
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Site: Itching at Injection Site-Mild, Systemic: Complained of \" tingling all over \" at 5:25 PM-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Complained of tingling approx 15 minutes after the injection. No rash noted. Stated some brief itching on left forearm, no rash noted. Refused Benadryl, stated he would take some at home. Vital signs at 5:30 PM, T 96.2, P 64 Regular, R 18, BP 128/80. No stridor, Vital signs at 5:53 PM, T 96.6 temporal, P 64 regular, R 20, no stridor, BP 110/80, no rash, went home at 5:55 PM. Stated he would take some Benadryl at home. Advised to pull over and dial 911 if any signs of respiratory distress/shock
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| 44 | 2021-04-22 | cold sweat |
Dizziness, light headedness, nausea, cold sweat, fatigue, sleepiness accompanied by low blood pressu...
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Dizziness, light headedness, nausea, cold sweat, fatigue, sleepiness accompanied by low blood pressure of 90/59 and a low pulse rate of 50 bpm 10 minutes following injection. Symptoms alleviated within 30 minutes of onset except fatigue without further intervention.
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| 44 | 2021-04-23 | speech disorder, seizure |
Blood clot in the brain, stroke, and seizure on 27th of March. Heparin drip, Keppra as a seizure med...
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Blood clot in the brain, stroke, and seizure on 27th of March. Heparin drip, Keppra as a seizure medication, blood thinner medication. No movement right arm and hand, speech difficulties, impairment of concentration.
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| 44 | 2021-04-24 | bell's palsy |
Bells Palsy; This is a spontaneous report from a contactable consumer (patient). A 44-year-old male ...
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Bells Palsy; This is a spontaneous report from a contactable consumer (patient). A 44-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 02Apr2021 15:00 (Lot Number: Er8737) as single dose (at the age of 44-years-old) for covid-19 immunisation. Medical history was reported as none. Patient had no known allergies. There were no concomitant medications in two weeks prior to the vaccination. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. Patient had no COVID prior vaccination. Patient was not tested for Covid post vaccination. On 08Apr2021 06:00 patient experienced bells palsy. Event resulted Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Prolongation of existing hospitalization (vaccine received during existing hospitalization). Therapeutic measures taken as a result of bells palsy included antibiotics and steroids. Patient had not recovered from the event, at the time of the report.
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| 44 | 2021-04-24 | feeling cold |
12 hours after first shot, had 48 hours of chills and nausea, recovered, 8 days after first shot had...
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12 hours after first shot, had 48 hours of chills and nausea, recovered, 8 days after first shot had 5 days of chills, fever, nausea, headache. 12 hours after second shot, had 24 hours of chills, nausea, fever, headache, recovered. 13 days after second shot, all symptoms returned for the 4th time
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| 44 | 2021-04-24 | tenderness | Bruise and tenderness underside of arm |
| 44 | 2021-04-25 | weakness |
Awoken the very next day by body aches and headache. Weakness. Over the next day or so, started to e...
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Awoken the very next day by body aches and headache. Weakness. Over the next day or so, started to experience light pain in scrotum area (first two weeks strong pain), and unable to empty bladder completely (always an urge to urinate even right after urinating). This bladder issue is ongoing, joint pain at times.
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| 44 | 2021-04-25 | weakness |
45 y/o male with no medical history seen today complaining of dizziness, and left arm weakness. Pati...
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45 y/o male with no medical history seen today complaining of dizziness, and left arm weakness. Patient denies any allergy. Per patient this is his first dose of the vaccine series. NP and paramedics at patient side. Vital sign obtained BP 149/97, bs 105, 98%, 19 RR, NSR on the monitor. Patient provided with a bottle of water and legs were elevated on a chair. Vital sign rechecked. 132/94, 96, 99% 19. Patient states he felt better. Patient discharge home accompanied by his wife.
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| 44 | 2021-04-25 | slurring |
This is sharing a concern / reporting a concern. This is not a complaint against anyone. This is not...
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This is sharing a concern / reporting a concern. This is not a complaint against anyone. This is not reporting side effect. The adverse effect date and time is a mandatory field. This is the reason I filled adverse date and time. I had my 2nd dose of vaccine on April 25, 2021 at campus at 1.20 PM. I just felt the syringe just touched the peripheral of my skin. I told the nurse that I do not feel I get the shot. Later, I do not feel any side effect any effect. I had no pain, or the site of injection was not swollen. I am worried I did not get the 0.3ml dose. During the first shot on April 4, 2021 at 1.43 PM, I felt pain on shoulders. I felt my tongue got thickened/ some tingling sensation on tongue and a little slur in speech. After 6 hours, I felt headache, a little chill, light head, nausea, more pain on shoulders and the next day, I felt light headedness and I felt tired for few days. I consider these as normal side effects and nothing unusual from what I read in internet and what I heard from others. So, I did not report it and it was a normal thing for me. Since I experienced this in first dose, I expected a more severe reaction than first dose. But I did not even feel pain at the site of injection nor any usual symptoms that usually appear. This made me to doubt I got required dose or the vaccine was correctly withdrawn from the vile. I do not know how to confirm that I got correct dosage. If I have not received the full dose, I am ready to take an additional shot and I would be flexible to take the shot at the available time near to my living place on any day. Again, I am not complaining anything. Probably the nurse is very proficient in taking shot with no pain. I do not know why my body does not react to the second dose.
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| 44 | 2021-04-25 | feeling hot |
Pt received Covid vaccine complained of pounding headache, dizziness, chest pressure, feeling hot a...
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Pt received Covid vaccine complained of pounding headache, dizziness, chest pressure, feeling hot all over. BP 131/87. HR 82, RR 18, O2 sat 98%, temp 98.3. Pt taken to Emergency Department to further care required.
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| 44 | 2021-04-25 | feeling hot |
Patient began to feel hot and sweaty after injection. Pharmacist took patient's temperature, which w...
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Patient began to feel hot and sweaty after injection. Pharmacist took patient's temperature, which was 96 F. Patient still felt hot and was lethargic but remained responsive. 911 was called when patient stared to droop head to side as if he was falling asleep. We provided cooling measures and kept patient awake until paramedics arrived.
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| 44 | 2021-04-26 | weakness |
Two days following the shot I was unable to put weight on my left arm. I went to an orthopedic speci...
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Two days following the shot I was unable to put weight on my left arm. I went to an orthopedic specialist and she said it was likely that the shot had weakened my deltoid and the connective tissue in the shoulder was irritated trying to compensate.
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| 44 | 2021-04-27 | pain in extremity |
Dizziness, body aches, headache, strong fatigue, sweating and chills at night, vibration feeling thr...
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Dizziness, body aches, headache, strong fatigue, sweating and chills at night, vibration feeling throughout body, sore arm
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| 44 | 2021-04-28 | weakness |
Delirium; Severe fever 102+; Aches; chills; Restlessness; Headache; Weakness; This is a spontaneous ...
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Delirium; Severe fever 102+; Aches; chills; Restlessness; Headache; Weakness; This is a spontaneous report from a contactable consumer (patient). A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration administered in arm right on 14Apr2021 09:30 AM (Lot Number: EW0158) at vaccination age of 44 years old as single dose for covid-19 immunisation. Medical history included hypertension, high cholesterol, Cephalosporin allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications within 2 weeks of vaccination included atorvastatin calcium (LIPITOR) taken for blood cholesterol increased; tadalafil (CIALIS). The patient previously took 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot: EN6206) via an unspecified route of administration administrated in Left arm on 24Mar2021 at time of 09:45 AM at vaccination age of 44 years old as single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe fever, 102+, aches, chills, delirium, restlessness, headache, weakness on 14Apr2021 at time of 11:00 PM. No treatment received for the adverse event. The patient underwent lab tests and procedures which included body temperature: greater than 102 fahrenheit on 14Apr2021. The outcome of events was recovering. Since the vaccination, the patient had not been tested for COVID-19.
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| 44 | 2021-04-28 | cold sweat, feeling cold |
Patient started feeling sweaty and clammy about 20 minutes after his second vaccination. We were wat...
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Patient started feeling sweaty and clammy about 20 minutes after his second vaccination. We were watching him for 30 minutes. He asked to have his blood pressure checked. He was cold and sweating and said he was having chest pain. We called 911. his blood pressure was high but his pulse was normal. The EMT took the patient to run tests.
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| 44 | 2021-04-29 | pain in extremity | Sore arm. |
| 44 | 2021-05-06 | pain in extremity |
Stinging in pinky on hand opposite of vaccine. It would happen once or twice a day up to about 10 ti...
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Stinging in pinky on hand opposite of vaccine. It would happen once or twice a day up to about 10 times a day. The pain has dulled over the past two weeks, but still occurs.
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| 44 | 2021-05-07 | bell's palsy |
got Bell's palsy, On the right side of his face; This is a spontaneous report from a non-contactable...
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got Bell's palsy, On the right side of his face; This is a spontaneous report from a non-contactable consumer. A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot EW0150, first dose) solution for injection intramuscular on 05Apr2021 (at the age of 44-years-old) as a single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. The patient got Bell's palsy, on the right side of his face on 19Apr2021 with seriousness criteria of hospitalization. Treatment for the event Bell's palsy included prednisone at 20 mg tablet, 3 tablets by mouth daily; and acyclovir 800 mg tablet, orally one tablet by mouth 5 times daily for 10 days from 19Apr2021. The outcome of the event Bell's palsy was not recovered.
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| 44 | 2021-05-07 | tingling, numbness |
I had a stroke affecting the left side of my body. The stroke was in the pons area of my brain stem...
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I had a stroke affecting the left side of my body. The stroke was in the pons area of my brain stem. I noticed tingling in my left hand and the bottom of my left foot. I assumed it was just my back being out a bit and was going to get it put back in line the next day. When I woke up on Friday 4-23-21 my left side from the top of my head to the bottom of my left foot was numb and tingling. I went to the ER at that point to find out about the stroke.
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| 44 | 2021-05-18 | muscle spasms |
possible hallucinations; severe chills; severe back spasm; nausea; dizziness; the lymph node under m...
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possible hallucinations; severe chills; severe back spasm; nausea; dizziness; the lymph node under my right arm (the arm that was injected) was swollen to the size of a softball.; This is a spontaneous report from contactable consumer (patient). A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EP7533) via an unspecified route of administration, administered on the right arm on 30Apr2021 09:15 (Batch/Lot Number: EP7533) as unknown, single for COVID-19 immunization. The patient had no medical history. Concomitant medication included ascorbic acid, betacarotene, biotin, boron, calcium, calcium pantothenate, chloride, chromium, colecalciferol, copper, cyanocobalamin, folic acid, iodine, iron, lycopene, magnesium, manganese, molybdenum, nickel, nicotinamide, phosphorus, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, silicon dioxide, thiamine, tin, tocopheryl acetate, vanadium, vitamin k nos, zinc (CENTRUM MEN). The patient had severe chills, severe back spasm, nausea, dizziness, possible hallucinations, and the lymph node under my right arm (the arm that was injected) was swollen to the size of a softball on 30Apr2021 07:00 PM. No treatment was received for the events. Events were reported as non-serious: did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. The facility where the vaccine was administered was in a Public Health Clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. No known allergies. Outcome of the events was recovering.
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| 44 | 2021-05-23 | inability to speak, slurring |
5/24/21 - 44-year-old male with a past medical history significant for nicotine dependence, marijuan...
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5/24/21 - 44-year-old male with a past medical history significant for nicotine dependence, marijuana use, who presents for slurred speech. Accompanied by wife. Patient was in his normal state of health until Friday when he got his Pfizer Covid vaccine. About 5 hours later he was noted to have a headache and some slurred speech but patient and wife did not think anything of it. They went to some graduation parties this weekend and his speech continued to get worse which is what prompted them to present to the ED today. He denies that this is happened before. Feels like it is difficult for him to find words but not to actually say words. He does surf but denies being in murky water or swimming in fresh water. He denies IVDU. No underlying coagulopathy or cardiac history.
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| 44 | 2021-05-24 | pain in extremity | patient called pharmacy and complained that his arm still hurt 6 days after initial vaccination |
| 44 | 2021-05-25 | pain in extremity | Pain and limited range of motion in left upper arm/shoulder. |
| 44 | 2021-05-27 | numbness and pain in extremities, pain in extremity | Neuropathy in the right arm (not the arm I got the shots), irradiating to head and left foot. |
| 44 | 2021-05-27 | tingling, numbness, flushing |
Patient experienced apprehension, flushing and numbness and tingling. Patient verbalized "Throat ti...
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Patient experienced apprehension, flushing and numbness and tingling. Patient verbalized "Throat tightness" and elevated BP even though pt reports being on BP medications. O2 sat and pulse remained normal. Lungs CTA. Patient has a history of reactions to bee stings. Pt was given 50mg Diphenhydramine observed by staff and released
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| 44 | 2021-05-27 | tremor, unresponsive to stimuli |
Pt felt dizzy immediately after injection, pt had a slight tremor and labored breathing, counselled ...
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Pt felt dizzy immediately after injection, pt had a slight tremor and labored breathing, counselled pt to take deep breaths and stay seated, pt tried to stand and fell to the floor unconscious where he remained breathing but unresponsive for over 1 minute, came to on his own.
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| 44 | 2021-05-31 | weakness |
1st shot 4/13, no issue with injection site. About a week later had trouble breathing, chest pain, f...
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1st shot 4/13, no issue with injection site. About a week later had trouble breathing, chest pain, felt like lungs were hurting in my back, weak, tired, couldn't catch my breath when i went upstairs and almost passed out. 2nd shot 5/04, felt pain at injection site (that was expected), that night started to get a bad headache and got worse and worse. Next morning, whole body aching, upper body, lower back, bad headache, Left underarm (lymph) swollen. 2nd day slight headache, neck ache, left underarm swollen. That night had rash on arms, chest, and stomach. 3rd day, nighttime rash arms, chest, stomach. Still red where band aid was over injection site. Over a week later still have redness shape of band aid, Seems I have sensitive skin since the 2nd covid shot. 10 days after 2nd shot I still have redness the shape of the Band Aid on my left arm. Got a red spot on my nose (looks like Rosacea). 4 weeks later, still have a red spot on my nose. I have itchiness between fingers left hand, on my face left side, neck, arms (left wrist, right arm in places) redness on chest, and rashes on back, left buttocks, and itchiness on legs. i noticed that it gets worse at night. As far as i know i did not get the Covid Virus, i did the rapid test and regular test and both were negative. But i was very sick with my stomach and had issues breathing in late 2019 and again early 2020, took medication (antibiotics) both times. I had to write on this form over and over again kept getting frozen with error from the PDF. Even if I hit OK, it keeps popping up and does not let me finish, so I can imagine that lots of people gave up, like I may. Pfizer 4/13/2021 EW0162. After 5pm Pfizer 5/04/2021 EW0170. After 2pm
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| 44 | 2021-05-31 | tingling |
Patient presented to the ED on 5/8/21 with hypertensive emergency. Per ER provider's notes: He was a...
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Patient presented to the ED on 5/8/21 with hypertensive emergency. Per ER provider's notes: He was at the VA today getting his 2nd Covid vaccine (Pfizer) and during the post vaccine waiting period, he developed frontal headache and transient L arm tingling. He was sent to ED in Superior and BP was as high as 219/114. He was given amlodipine and toradol and dilaudid and BP did not come down. He also had a slight elevation in troponin and had second episode of L arm tingling. Decision was made to not give ntg since he already had a headache. No chest pain or other neuro sx. Head CT neg for bleed. No chest pain. Patient presented to the ED again on 5/11/21 with similar symptoms as previous visit.
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| 44 | 2021-06-01 | pain in extremity |
rash on arms; little restless; noticed how sore his arm was/pain in his arm; trouble sleeping/proble...
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rash on arms; little restless; noticed how sore his arm was/pain in his arm; trouble sleeping/problems with sleep; felt movements in his chest at times; felt like he had COVID all over again/ if he possibly has COVID-19 again; soreness; heart rate accelerated; some swollen in lymph nodes; This is a spontaneous report from a contactable pharmacist (patient) via a Pfizer sponsored program. A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Mar2021 at around 13:00 or 13:30 (at the age of 44 years old) (Lot Number: EP7534, unknown expiration) as 1st dose, single for COVID-19 immunisation. Medical history included COVID-19 in Nov2020; sneezing and runny nose both on 21Mar2021. The patient's concomitant medications were not reported. The patient reported that he received his first dose of Pfizer COVID vaccine on 22Mar2021. He felt fine after receiving the vaccine, but there was little bit rash on arms just afterwards and felt maybe a little restless but felt fine and went for a walk on 22Mar2021. As the night went on, he really noticed how sore his arm was/pain in his arm and when he was sleeping, he had trouble sleeping/problems with sleep (Mar2021) and felt movements in his chest at times (Mar2021). It felt like he had COVID all over again and had chills, soreness, and his smell was kind of gone in Mar2021. He was previously feeling pretty good. He had COVID-19 in Nov2020, and his symptoms feel very similar including loss of sense of smell but no coughing. He had a fever but that has gone away in Mar2021 and he did not take aspirin or anything for it. He also had fatigue, some swollen in lymph nodes, and his heart rate accelerated in Mar2021. He had sneezing and runny nose the day prior to receiving the vaccine. The patient would like to know if his symptoms are related to the vaccine or if he possibly has COVID-19 again. His symptoms are the same as COVID as far as what he can see, and his symptoms are really high. He would like to know if he can still receive the second dose of the vaccine if he has a positive COVID test after the first dose of the vaccine. The patient mentioned that there was very pretty high percentage of people having the symptoms after having the vaccine, kind of virus "causing". The patient asked if he needs to be tested to see if he had the virus before he was vaccinated and to know if these are one of the side effects or one of the symptoms of the virus, and to make sure that these are not actually corona virus. The patient recovered from fever in Mar2021, while unknown outcome for the remaining events. No follow-up attempts are possible. No further information is expected.
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| 44 | 2021-06-04 | feeling cold |
Very cold and full body aches; Very cold and full body aches; This is a spontaneous report received ...
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Very cold and full body aches; Very cold and full body aches; This is a spontaneous report received from a contactable consumer (Patient, self-reported). A 44-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiry date: not reported), dose 2 via an unspecified route of administration, in the left arm, on 24Feb2021 at 15:30, as single dose for COVID-19 immunisation in the school or student health clinic. The patient's medical history and concomitant medications was not reported. The patient was not allergic. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiry date: not reported), dose 1 via an unspecified route of administration, in the left arm, on 03Feb2021 at 17:30, as single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medication within 2 weeks. The patient was not diagnosed with COVID-19 prior to vaccination. On 26Feb2021 09:00, the patient experienced very cold and full body aches. No treatment was received. The patient not tested for COVID-19 since the vaccination. The outcome of the events was recovered on an unknown date in 2021. No follow-up attempts are Possible. Information on lot/batch cannot be obtained.
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| 44 | 2021-06-06 | migraine |
sensitivity to light, nausea, migraine (5 days), lightheadedness overall lasted for approximately 1...
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sensitivity to light, nausea, migraine (5 days), lightheadedness overall lasted for approximately 15 days with various symptoms
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| 44 | 2021-06-07 | feeling hot |
I was driving home from my town to another town. About 15 mins I thought I had to take leak and my g...
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I was driving home from my town to another town. About 15 mins I thought I had to take leak and my groin area was warming up on the inside and then it started to burn up on the inside and it was painful I was thinking what could have caused and it then I realized I had the pfizer vaccine and then I have implant all of sudden I loss use of arms and it took about 20 mins for me to get use in them and then they started to burn up on the inside. Later on that night I started to cough really bad and my lungs had a hard time keeping me breathing and then I knew I had got the covid from the shot and it was much worst than the actual covid. This was the first dose of the pfizer that I got these reactions and plus I heard about how the vaccine has been sterlizing people from having kids. I knew that the pfizer vaccine is 100% unsafe for anybody to take and that it was a bad batch or wrong vaccine. But I am letting you know that you need to keep money set aside for damages from the vaccine. But please do not be like the other states giving people money, guns, trucks for getting the vaccine. I am warning people not to get it because I almost die in the first dose of the pfizer vaccine.
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| 44 | 2021-06-07 | muscle spasms |
Woke up day after with headache 2nd day after severe muscle spasms in arms , legs, chest and back ...
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Woke up day after with headache 2nd day after severe muscle spasms in arms , legs, chest and back 3rd days after muscle spasms over entire body
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| 44 | 2021-06-08 | discomfort |
fainted three times felt heavy tunnel vision and ringing in my ear 10 minutes after receiving the va...
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fainted three times felt heavy tunnel vision and ringing in my ear 10 minutes after receiving the vaccine
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| 44 | 2021-06-08 | tingling | Systemic: Joint Pain-Medium, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.) |
| 44 | 2021-06-10 | bell's palsy |
I had history of Bells Palsy and it occurred in Dec2009.Similar symptoms of Bells Palsy started on 2...
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I had history of Bells Palsy and it occurred in Dec2009.Similar symptoms of Bells Palsy started on 29May2021, 2 weeks after the Covid 2nd dose; I had history of Bells Palsy and it occurred in Dec2009.Similar symptoms of Bells Palsy started on 29May2021, 2 weeks after the Covid 2nd dose; This is a spontaneous report from a contactable consumer (patient). A 44-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 12May2021 10:45 (Batch/Lot Number: EW0177) as single dose for COVID-19 immunisation. Medical history included bell's palsy in Dec2009. The patient had no known allergies. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and any other medications within 2 weeks of vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 21Apr2021 10:15 (Batch/Lot Number: EB8731) for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient reported that he had history of Bells Palsy and it occurred in Dec2009. Similar symptoms of Bells Palsy started on 29May2021 at 7:00 AM, 2 weeks after the Covid 2nd dose. The patient consulted his physician and on medications (Steroid and Anti-infamotroy(inflammatory)) now. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the event was recovering.
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| 45 | 2020-12-31 | numbness | LEFT HAND NUMBNESS, FEELS DIFFERENT. 97.8, 118/77, 80 |
| 45 | 2021-01-03 | cold sweat, unresponsive to stimuli |
Patient became unresponsive for 10-15 seconds. Medical emergency called, along with 911. Upon reob...
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Patient became unresponsive for 10-15 seconds. Medical emergency called, along with 911. Upon reobtaining consciousness, patient was diaphoretic and clammy. Vital signs obtained - SBP in the 70s and HR in the 40s. Patient transport to the ED.
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| 45 | 2021-01-04 | breast pain |
12/23/2020 sharp pain left lower breast, chest constriction lasted approx for 2 days on and off. 12/...
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12/23/2020 sharp pain left lower breast, chest constriction lasted approx for 2 days on and off. 12/26/2020 swollen left armpit, resolved 01/04/2020. Antibiotic prescription provided.
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| 45 | 2021-01-04 | flushing |
received vaccine 12/21 and on 12/29 noted bilateral ear lobe swelling redness and facial flushing. o...
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received vaccine 12/21 and on 12/29 noted bilateral ear lobe swelling redness and facial flushing. on 12/30/2020 patient reports increased hive like rash on abdomen, trunk arms, and neck redness. Patient seen at her PCP and diagnosed with allergic reaction. Patient has taken benadryl and clariten and symptoms resolving.
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| 45 | 2021-01-06 | night sweats, pain in extremity |
joint pain; it doesn't seem to be feeling well; sweating; Fever; chills; night sweats, that he will ...
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joint pain; it doesn't seem to be feeling well; sweating; Fever; chills; night sweats, that he will randomly start sweating; headache; muscle pain/mild muscle aches; gastric upset; Fatigue; he had mild arm soreness right after he got the vaccine; This is a spontaneous report from a contactable Other-HCP (patient). This 45-year-old male Other-HCP received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685, NDC number: 59267-1000-1) on 22Dec2020 at single dose in his right arm for COVID-19 immunization. Medical history and concomitant drug were not reported. It was reported that patient experienced Fever on 27Dec2020 with outcome was recovered on 29Dec2020, chills and night sweats on 27Dec2020 with outcome was not recovered, Headache on 27Dec2020 with outcome was not recovered, muscle pain 27Dec2020 with outcome was not recovered, gastric upset on 27Dec2020 with outcome was Recovering, Fatigue on 27Dec2020 with outcome was unknown, arm soreness on 22Dec2020 with outcome was not recovered, joint pain with outcome was unknown, it doesn't seem to be feeling well with outcome was unknown, sweating with outcome was unknown. All events were serious (medical significant). Caller stated that he thought having a reaction to the vaccination, spoken with Occupational Health at his job and with a doctor, stated everyone is a bit stumped. Caller stated he has had for over a week now, fever, chills, night sweats, that he will randomly start sweating, headache, joint pain, gastric upset, and it doesn't seem to be feeling well. Stated the joint pain is actually more muscle pain. Stated he got the vaccination on Tuesday 22Dec2020, stated he has been having these symptoms for over 5 days now. Stated he does not think this is something infectious, that no one in his family is getting sick, his wife or child are not catching it from him. Stated he tried to do research online for data about delayed side effects, would like to know if we have any information on delayed side effects. Stated he considers these events medically significant because he cannot be cleared to go back to work. Stated he had mild arm soreness right after he got the vaccine, states he had mild muscle aches Wednesday and Thursday, then they went away and came back all on Saturday night and Sunday. Stated he is worried about getting a second vaccine. Stated he tested negative for the COVID on 29Dec2020. Stated he has a CBC and other blood work scheduled for today, results unknown at this time. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the compatible temporal association and the drug's known safety profile, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 45 | 2021-01-07 | weakness |
While on duty and in uniform as an emergency paramedic I received my second scheduled covid19 vacci...
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While on duty and in uniform as an emergency paramedic I received my second scheduled covid19 vaccination. Approximately five minutes after receiving C19 dose 2 vaccination (1335hrs). I experienced a syncopal episode while walking back to my work area and was lowered to the ground by another EMS provider. I was then placed in a wheelchair by the EMS provider and an RN and taken to the emergency department at Medical Center. (1337hrs) I regained alertness and felt severe nausea and general weakness and was assisted into in ER bed. Staff doctor attended along with RN . An assessment was completed, 12 lead EKG completed, IV established, 8mg Zofran administered, 1000ml of Normal Saline was bolused. Labs were drawn. ED staff continued to monitor me for the next 2 plus hours I was monitored for anaphylaxis and other symptoms. My symptoms of nausea mostly resolved and my strength returned. A Resident MD completed a final evaluation and determined it was safe for me to be discharged. (1607hrs)
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| 45 | 2021-01-07 | tingling | LEFT ARM PARASTHESIA HAD MILD TINGLING DOWN LEFT ARM |
| 45 | 2021-01-07 | tingling |
polyneuropathy; facet joint diagnosis/new left forefoot paresthesia; This is a spontaneous report fr...
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polyneuropathy; facet joint diagnosis/new left forefoot paresthesia; This is a spontaneous report from a contactable physician (patient). A 45-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot EJ1685) at the first dose in left arm on 17Dec2020 12:45 at single dose for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered at Doctor's office/urgent care. Medical history included ongoing back pain (thinking it was due to running/physical therapy overuse injury). No allergies to medications, food, or other products. There were no concomitant medications. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. It was reported that 20Dec2020 morning: new left forefoot paresthesia. no weakness. Patient thought this might be due to the back pain he had been watching for 3 months, thinking it was due to running/physical therapy overuse injury. On 21Dec2020 sports medicine physician evaluation. numbness was gone, facet joint diagnosis, MRI lumbar ordered (still pending). On 24Dec2020 9 pm, paresthesia both hands and feet, no weakness nor other symptoms those continued and were slightly worse on 27Dec2020 morning, including face/teeth. no other symptoms; 27Dec2020 afternoon: internal medicine physician evaluation, working diagnosis polyneuropathy. Neurologist appointment will be 07Jan2021, 2 hours before 2nd shot was scheduled. The patient had been tested for COVID-19 test type post vaccination: negative on 22Dec2020. No treatment for event. Prior to vaccination, the patient was not diagnosed with COVID-19. Outcome of events was not resolved.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of polyneuropathy and facet joint diagnosis/new left forefoot paresthesia due to temporal relationship. However, the reported events may possibly represent intercurrent medical conditions in this patient. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including nerve conduction tests, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 45 | 2021-01-09 | pain in extremity |
After first dose: arm pain a few hours after and chills 24 hours later that lasted 24hrs. Some join...
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After first dose: arm pain a few hours after and chills 24 hours later that lasted 24hrs. Some joint pains persisted. After second dose: arm pain a few hours after. Twelve hours later I had chills, low grade fever 100.5, body aches, arthralgias, fatigue. These symptoms lasted for 24 hours continuously. 48 hrs later I still had fatigue and early morning chills. The body aches have continued to present time.
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| 45 | 2021-01-09 | tingling |
Patient developed chills/shivering/tingling day 4 post-injection. The episodes are occurring every ...
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Patient developed chills/shivering/tingling day 4 post-injection. The episodes are occurring every 10 minutes and last 30-45 seconds. Symptoms continue at day 11 post injection. Symptoms are similar to the patients pre-ictal aura. However, no generalized seizures have occurred.
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| 45 | 2021-01-09 | tingling |
Increased bp, diaphoretic, skin turned red, pins and needle sensation, increased heart rate , swoll...
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Increased bp, diaphoretic, skin turned red, pins and needle sensation, increased heart rate , swollen lower lip, nauseated, weird sensation of not feeling right almost like out of body
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| 45 | 2021-01-11 | cold sweat |
Patient had vertigo, dizziness, cold sewats, redness near side of neck repoerted agter 15 minutes of...
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Patient had vertigo, dizziness, cold sewats, redness near side of neck repoerted agter 15 minutes of observation. HR was nor remarkable, went from 80's to 90's. After addiitonal 10 minutes rapid response was iniciated and patient was given water
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| 45 | 2021-01-11 | feeling cold | HA, Nausea, fever, chills, stayed home |
| 45 | 2021-01-11 | pain in extremity |
loss of smell and taste; loss of smell and taste; low grade fever; Flu-like aching; headache; coughs...
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loss of smell and taste; loss of smell and taste; low grade fever; Flu-like aching; headache; coughs; soreness of the arm; This is a spontaneous report from a contactable consumer (patient work in detention center). A 45-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL1284, Expire Date: 30Apr2021), via an unspecified route of administration on 05Jan2021 07:45 in the right arm at single dose for covid-19 immunisation. Medical history included covid-19 from 26Dec2020 was recovering. The patient's concomitant medications were not reported. The patient experienced soreness of the arm on 05Jan2021 with outcome of recovering, loss of smell and taste on 06Jan2021 04:00 with outcome of not recovered, headache on 06Jan2021 with outcome of recovered, coughs on 06Jan2021 with outcome of not recovered, low grade fever on 06Jan2021 02:30 with outcome of unknown, flu-like aching on 06Jan2021 01:00 with outcome of recovering. The detail clinical course was provided as consumer calling regarding the COVID 19 vaccine. He received first dose of the Pfizer COVID 19 vaccine on 05Jan2021 07:45am in the right arm. He noticed by the afternoon his arm was sore. He worked overnight so at 01:00AM 06Jan2021 he noticed achy, like flu ache in his muscles. He took his temperature and it was 99.4 around 02:30 in the morning. Then at 04:00am he noticed he couldn't smell or taste anything. He went home and fell asleep. When he woke up he had a headache and coughing. He took Dayquil which helped with the coughing and then the headache went away. He has had the coughing all through the COVID infection. The patient underwent lab tests and procedures which included body temperature: 99.4 on 06Jan2021 02:30, COVID 19 test PCR positive 26Dec2020. The events were reported as non-serious. Mentioned he was told if you already had COVID the side effects of the vaccine may be worse. He was planning to receive the second dose 26Jan2021.
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| 45 | 2021-01-11 | pain in extremity |
Chills/rigors starting about 16 hours post-vaccine (second dose), lasting intermittently for 24 hour...
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Chills/rigors starting about 16 hours post-vaccine (second dose), lasting intermittently for 24 hours, improved with a Tylenol. Sore arm starting about 2 hours post-vaccine, lasting about 24 hours, improved with Tylenol.
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| 45 | 2021-01-12 | feeling hot |
Rash/rash on his forearm that went to both forearms; elevated blood pressure/He already has high blo...
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Rash/rash on his forearm that went to both forearms; elevated blood pressure/He already has high blood pressure and it was elevated after the vaccine; felt warm inside; This is a spontaneous report received from a contactable consumer (patient). A 45-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number and expiry date unknown), via an unspecified route of administration in left arm, on 06Jan2021, at single dose, for COVID-19 immunization. Medical history included high blood pressure from Apr2020 and ongoing. Ongoing concomitant medication included lisinopril from Apr2020 for blood pressure/high blood pressure. The patient received the vaccine between 1:30-2:00pm yesterday afternoon (06Jan2021). He waited for 15 minutes after receiving the vaccine and he was ok. Later, on 06Jan2021, he developed a rash on his forearm that went to both forearms. He already has high blood pressure and it was elevated after the vaccine. During the night he felt like he was warm inside. He took a low dose Bayer Aspirin. The outcome of the event rash and hypertension was not recovered, and the outcome of the event feeling hot was recovered on 07Jan2021. Information on the lot/batch number has been requested.
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| 45 | 2021-01-13 | night sweats |
Pfizer-BioNTech COVID-19 Vaccine EUA - I woke up in the middle of the night sweating, and felt tired...
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Pfizer-BioNTech COVID-19 Vaccine EUA - I woke up in the middle of the night sweating, and felt tired the next morning with slight brain fog. Otherwise, I felt fine.
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| 45 | 2021-01-17 | weakness | Very weak and tired immediately after vaccine. |
| 45 | 2021-01-17 | burning sensation |
Approximately 2 days after 2nd injection I started developing itchy hands with associated swelling a...
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Approximately 2 days after 2nd injection I started developing itchy hands with associated swelling as well. 4 days after injection I developed a rash to feet, legs, groin and parts of torso with associated swelling. No shortness of breath but do have some slight burning to hands and legs with mild pain.
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| 45 | 2021-01-19 | numbness, tingling |
lightheadedness; tingling, slslight numbness right arm andd face. informed patient that if it contin...
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lightheadedness; tingling, slslight numbness right arm andd face. informed patient that if it continues to go to ER. Pataient leeft with understanding above.
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| 45 | 2021-01-19 | pain in extremity |
Swollen and painful lymph nodes in left armpit. Swelling lasted 2 days. Pain lasted 3 days. Symptoms...
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Swollen and painful lymph nodes in left armpit. Swelling lasted 2 days. Pain lasted 3 days. Symptoms were treated with Tylenol, Advil, and propping left arm up with a pillow to prevent pressure on under arm area.
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| 45 | 2021-01-21 | numbness |
Received second dose of Pfizer COVID vaccination on January 9, 2021. At the time of the vaccinatio...
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Received second dose of Pfizer COVID vaccination on January 9, 2021. At the time of the vaccination he experienced discomfort of left deltoid (site of injection) as well as paresthesia at the injection site. He also experienced systemic symptoms of fatigue, myalgias, and arthralgias for 24 to 36 hours. Over the course of the next several days he experienced continued significant numbness and weakness in left upper extremity, specifically in left deltoid muscle. By Sunday 1/17/2021 the significant left deltoid weakness and numbness persisted, specifically not being able to lift his arm greater than 45 degrees using his deltoid. He contacted health on 1/17/2021. On 1/19/2021 he had a consultation with a physician. Based upon his clinical examination, and symptom complex, physician does not believe that this is a cervical spine issue but rather a local nerve injury related to the injection site. He was prescribed a steroid taper. Unclear whether this is temporary or permanent issue.
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| 45 | 2021-01-25 | weakness | He has a fever of 102.2 and having chills and body aches complaint about lack of energy . |
| 45 | 2021-01-25 | tingling |
PT C/O FLUTTERING HEART, HEART BEATING FAST, DRY MOUTH, TINGLING IN CHEEKS. 1140: V/S TAKEN BP:158/1...
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PT C/O FLUTTERING HEART, HEART BEATING FAST, DRY MOUTH, TINGLING IN CHEEKS. 1140: V/S TAKEN BP:158/100 P: 110 RESP 16 SPO2 99%, ELEVATED BP AND PULSE. 1145: ADMIN OTC BENADRYL x 2 CAP PO. PT TOLERATE WELL. 1148: V/S TAKEN BP:150/96 P: 92 RESP 12 SPO2 99%. 1150: PT STATES THAT HE IS FEELING BETTER. A&Ox4. 1153: V/S TAKEN BP:150/96P: 92RESP 12 SPO2 99%. 1200: V/S TAKEN BP:146/92P: 91RESP 12 SPO2 98%. PT INSTRUCTED NOT TO DRIVE, AND F/U WITH PCM IN REGARDS TO H/O OF TIA WITH TODAYS V/S ELEVATED BP AND PULSE. PT WAS FEELING BETTER AND STABLE.
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| 45 | 2021-01-26 | burning sensation |
coronary spasm; STEMI COVID vaccine induced; slight 1-2/10 substernal chest pain on/off; fever of 10...
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coronary spasm; STEMI COVID vaccine induced; slight 1-2/10 substernal chest pain on/off; fever of 101 to 101.7; diffuse severe muscle aches; tachycardia of 110 to 130; painful lymphadenopathy of the ipsilateral axilla and clavicular lymph node (LN); This is a spontaneous report from a contactable physician (patient). A 45-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL0142), via an unspecified route of administration in the left arm on 13Jan2021 at a single dose for COVID-19 immunization. The patient's medical history included benign prostatic hyperplasia (BPH). Concomitant medication included alfuzosin. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) in the left arm on 23Dec2020 16:00 at the age of 44 years old for COVID-19 immunization. On 14Jan2021, the patient started having fever of 101 to 101.7, diffuse severe muscle aches, and tachycardia of 110 to 130. Thursday evening (14Jan2021) through Sunday (17Jan2021), the patient also had painful lymphadenopathy of the ipsilateral axilla and clavicular lymph node (LN). Thursday evening (14Jan2021), the patient had slight 1-2/10 substernal chest pain on/off. Friday evening around 23:30 (15Jan2021), the patient had chest pain substernal 7-8/10 that lasted for one hour. The burning sensation was worse with cold air. It resolved with paracetamol (TYLENOL) and ibuprofen. Monday early morning at 04:00 (18Jan2021), the patient experienced STEMI COVID vaccine induced wherein the patient woke up with 10/10 chest pain and shoulder pain which lasted for 30 to 40 minutes and resolved with paracetamol and ibuprofen. The patient also decided to check blood work Monday morning (18Jan2021) while in the hospital. Trop came back 16.28 ng/ml. This is the old trop not high sensitivity. Normal high is 0.30 ng/ml. The patient went to the hospital. ECG showed ST elevation inferior lead. Left heart catheterization was done. The patient have clean coronaries. No evidence of any atherosclerosis. Echocardiogram showed normal EF. No wall motion abnormality. It was concluded that the patient also had coronary spasm. The patient underwent other lab test and procedure which included nasal swab COVID test showed negative on 18Jan2021. Outcome of the lymphadenopathy was recovered on 17Jan2021, of the chest pain was recovered on Jan2021, of the coronary spasm and STEMI was recovering, while of the remaining events was unknown. The events coronary spasm and STEMI resulted in hospitalization and life threatening illness.; Sender's Comments: The reported coronary spasm with chest pain and suspected STEMI were likely related to the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) due to plausible temporal relationship, and no evidence of any atherosclerosis during left heart catheterization. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 45 | 2021-01-27 | pain in extremity |
The next morning I started to have some pain in my right calf which worsened throughout the day. Th...
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The next morning I started to have some pain in my right calf which worsened throughout the day. The following day I went to the ER with a DVT. I was given Xarelto for treatment.
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| 45 | 2021-01-29 | tenderness |
15-36 hours after: headache, chills, injection site pain 9 days after: Hair follicle and or skin ...
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15-36 hours after: headache, chills, injection site pain 9 days after: Hair follicle and or skin tenderness concentrated to the back left lower quadrant of head.
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| 45 | 2021-01-31 | pain in extremity |
achiness in his legs and hands; Chills; Fatigue; injection site swelling and achiness; injection sit...
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achiness in his legs and hands; Chills; Fatigue; injection site swelling and achiness; injection site swelling and achiness; This is a spontaneous report from a contactable consumer via the Pfizer-sponsored program. A 45-years-old male patient received bnt162b2 (BNT162B2; Batch/lot number: EK4176), via an unspecified route of administration at left arm on 13Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history reported as none. There were no concomitant medications. The patient experienced fatigue on 17Jan2021 with outcome of not recovered, achiness in his legs and hands on 18Jan2021 with outcome of not recovered, chills on 18Jan2021 with outcome of not recovered, injection site swelling and achiness on 13Jan2021 with outcome of recovered on 14Jan2021. The patient reported after he got the first COVID vaccine on 13Jan2021 he experienced fatigue, achiness, and injection site swelling. Patient wanted to know if this is normal after the first dose and this was discussed. Patient explained that the fatigue - this didn't start until 17Jan2021 and was ongoing. On 18Jan2021 he starting having achiness in his legs and hands and he also had a few chills today. The injection site swelling and achiness there, was gone after the 14Jan2021. Patient was really looking for an answer to his question on if it was normal or should he get a COVID test. He was on day 5 after getting the vaccine and from what he read most people have side effects within a 24 hours and gone within 48 hours. Some of his side effect didn't start until 4 days later. The Vaccination Facility Type was hospital. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. Patient did not go to Emergency Room or Physician Office. There was no Prior Vaccinations (within 4 weeks).
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| 45 | 2021-02-02 | pain in extremity | Currently experiencing bodyaches and soreness in the left arm |
| 45 | 2021-02-03 | pain in extremity |
arm soreness, fatigue Narrative: Developed arm soreness and fatigue following vaccine administratio...
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arm soreness, fatigue Narrative: Developed arm soreness and fatigue following vaccine administration. Resolved by 1/1/21.
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| 45 | 2021-02-07 | numbness |
Local nerve injury/significant numbness and weakness in his upper extremities specifically in his le...
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Local nerve injury/significant numbness and weakness in his upper extremities specifically in his left deltoid muscle, affects his ability to perform usual work; At the time of vaccination he experienced discomfort in left deltoid which was the injection site; Cannot lift his arm greater than 45 degrees; Systemic fatigue ,myalgia and other arthralgia for 24-36 hours; Systemic fatigue ,myalgia and other arthralgia for 24-36 hours; Systemic fatigue ,myalgia and other arthralgia for 24-36 hours; Developed significant numbness and weakness in his upper extremities specifically in his left deltoid muscle; Developed significant numbness and weakness in his upper extremities specifically in his left deltoid muscle; This is a spontaneous report from a contactable pharmacist. A 45-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231), intramuscular n deltoid left on 09Jan2021 at single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. At the time of vaccination he experienced discomfort in left deltoid which was the injection site, cannot lift his arm greater than 45 degrees, local nerve injury, systemic fatigue ,myalgia and other arthralgia for 24-36 hours, developed significant numbness and weakness in his upper extremities specifically in his left deltoid muscle, affects his ability to perform usual work or task, all in Jan2021 with outcome of unknown. He called the employee health on 17Jan2021 and 19Jan2021 he saw a neurosurgeon. The neurosurgeon didn't think it was a cervical spine injury rather a local nerve injury related to the injection itself and he was prescribed a steroids taper, unclear whether if it was a temporary or permanent issue. Because this was like 10 days after the vaccine and he didn't really describe how much this issue affected his ability to perform usual work or task but he was a surgeon. The outcome of the events were unknown.; Sender's Comments: Based on the compatible time association, the peripheral nerve injury is possibly related to the injection technique, not vaccine BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 45 | 2021-02-08 | weakness |
felt dizzy and weak. Was diaphoretic. BP at time was 98/32 w P 64. chest clear, no SOB no oral swell...
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felt dizzy and weak. Was diaphoretic. BP at time was 98/32 w P 64. chest clear, no SOB no oral swelling. Rested supine for 30 minutes. Felt much better. BP 118/72, P 68
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| 45 | 2021-02-08 | feeling hot, pain in extremity |
45-year-old male follow-up from the ER. He received a COVID-19 vaccine on 1/22/2021. This was his fi...
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45-year-old male follow-up from the ER. He received a COVID-19 vaccine on 1/22/2021. This was his first dose. He began having bilateral lower extremity pain the following evening. In addition to the pain, he has been dealing with headaches, dizziness, auditory hallucinations, and large areas of redness and warmth on the left upper extremity and bilateral lower extremities. He went to the ER on 1/27/2021. Upon review of those records, he had microscopic hematuria. The patient states that he passed some kidney stones this week. Other abnormal labs include very elevated liver enzymes which the patient has not had before. He does not drink any alcohol. No new medications. He also had thrombocytopenia. O) Gen: Patient is in a wheelchair during today's exam. This is the first time he ever been in the exam room in a wheelchair. He required assistance to stand up. He says the pain is what makes it so difficult to stand up. Skin: On the left forearm, there is a large area of redness and swelling. The redness is relatively faint. On the lateral aspect of the right thigh, there is a large area of redness and swelling which is more prominent. ASSESSMENT 1. Severe myalgias 2. Elevated liver enzymes 3. Thrombocytopenia PLAN 1. Check sed rate and CRP. 2. Recheck CMP along with viral hepatitis panel and lipase. 3. Recheck CBC with differential. 4. Further recommendations based on these results. ADDENDUM Patient called on 2/1/2021 and reports his pain is getting worse to such an extent that he has been unable to make it to the bathroom fast enough and has been having accidents.
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| 45 | 2021-02-08 | unresponsive to stimuli |
Patient presented in normal healthy condition. After describing side effects and precautions, patien...
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Patient presented in normal healthy condition. After describing side effects and precautions, patient was administered vaccine through intermuscular route. Patient appeared to have a normal response to the administration and showed no reaction. The patients wife was the administered the vaccine within 2-3 minutes in the same treatment room. After her administration, the patient was noted with his head positioned forward, pale skin color and no response to questioning. At that point an emergency response was called. The patient remained unresponsive. At the time he was seated. Within about 2 minutes, the patient was laid on the floor and quickly returned to normal consciousness. The emergency squad was called and responded in about 10 minutes. By the time the emergency arrived the patient was fully recovered; he did not require further medical intervention.
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| 45 | 2021-02-09 | weakness |
Headache; Mild fever; Lack of energy; This is a spontaneous report from a contactable consumer (pati...
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Headache; Mild fever; Lack of energy; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3248; Expiration date was not reported) on 19Jan2021 at a single dose, with route of administration unspecified, for COVID-19 immunization at the workplace clinic. Medical history included Celiac disease and gluten allergy. Concomitant medication included fexofenadine hydrochloride (ALLEGRA). On 20Jan2021, the patient had headache, mild fever and lack of energy. The patient did not receive any treatment for the reported events. The outcome of the events, headache, mild fever and lack of energy, was recovered in Jan2021. The patient was not diagnosed with COVID-19 prior to vaccination, and was not tested post-vaccination. No follow-up attempts are possible. No further information is expected.
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| 45 | 2021-02-09 | weakness |
1. Moderate Pain Site of the Injection (started 12 hours after injection) lasted (4 days) 2. Painful...
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1. Moderate Pain Site of the Injection (started 12 hours after injection) lasted (4 days) 2. Painful Lymph-nodes : Location Right cervical , Right side supra clavicular and infra clavicular , lasted for 1 week 3. Light headed lasted 2 days 4.nauseas lasted 3 days 5 diarrhea mild lasted 2 days 6. Chills , lasted for 3 days 7 weakness , lasted 10+ days
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| 45 | 2021-02-10 | numbness |
Profuse sweating followed by headache and numbness to my head. After a few minutes my tongue began ...
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Profuse sweating followed by headache and numbness to my head. After a few minutes my tongue began to swell followed by my lips and face. Was given 50mg PO Benadryl five minutes later a shot from an EpiPen. Trip to ED via ambulance IV Benadryl and Solu-Medrol was administered. After 3 hrs all swelling was gone and was discharged.
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| 45 | 2021-02-16 | tingling |
Left arm began tingling immediately after shot 12/31/2020. Within a short time entire arm was tingl...
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Left arm began tingling immediately after shot 12/31/2020. Within a short time entire arm was tingling all the way to fingertips of left hand. Felt similar to when a limb "falls asleep". Continued for 2 days. Thereafter tingling sensation reduced but has not disappeared. Slight tingling still present at fingertips of left hand as of 2/17/2021. Second dose received in right arm 1/21/21. Symptom did not occur in right arm.
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| 45 | 2021-02-17 | cold sweat, tingling |
fainted; nausea; left arm began to tingle; dizziness; Broke out in a cold sweat; chills; Lost contro...
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fainted; nausea; left arm began to tingle; dizziness; Broke out in a cold sweat; chills; Lost control of my bladder.; This is a spontaneous report from a contactable consumer (patient). A 45-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL6269), via an unspecified route of administration in Left arm on 04Feb2021 15:00 (at the age of 45-years-old) at SINGLE DOSE for COVID-19 immunization. Medical history was reported as none. There were no concomitant medications. 51 hours after receiving the vaccine, the patient was sitting down watching a film. His left arm began to tingle, and he felt a wave of dizziness and nausea come over him. He stood up, walked a few steps and sat back down. He broke out in a cold sweat, chills, and saw stars. He leaned forward with his head in his hands, and apparently fainted for a moment and lost control of his bladder. All events started on 06Feb2021 06:00 PM. No treatment received for the events. The outcome of the events was recovered in Feb2021. No covid prior vaccination, no Covid tested post vaccination, no known allergies.
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| 45 | 2021-02-18 | numbness |
Injection site soreness (mild) and mild muscle soreness during first 24 hours after 2nd dose of vacc...
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Injection site soreness (mild) and mild muscle soreness during first 24 hours after 2nd dose of vaccination. At about 29-30 hours, noticed mild numb feeling along right jawline from middle of mouth to right ear, and around the right ear. By morning (about 48 hours post vaccination), numb feeling appears gone on right jawline, but seems to have moved to left jawline (still mild). No trouble breathing or eating at all. Consulted primary care doctor out of concern over odd sensation, but not treatments at this time. Considering taking a benadryl tablet just to see if it has any effect.
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| 45 | 2021-02-19 | facial paralysis, slurring |
Patient suffered ICH within 24 hours of receiving COVID vaccine. Symptoms include facial droop and m...
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Patient suffered ICH within 24 hours of receiving COVID vaccine. Symptoms include facial droop and mild dysarthria. Admitted to Neuro ICU for monitoring.
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| 45 | 2021-02-23 | weakness |
Roughly 30 minutes after administration of vaccine patient endorsed weakness, dizziness and shortnes...
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Roughly 30 minutes after administration of vaccine patient endorsed weakness, dizziness and shortness of breath. His blood pressure and heart rate increased during the event. He was treated with epinephrine 0.3mg IM due to concern for anaphylaxis and transferred to the ER via EMS. In the ER his vitals were stable and he was observed in the ER for 3 hours, with improvement in his symptoms. During the course of his stay he was treated with Benadryl, dexamethasone and albuterol. He presented with no hives, pharyngeal edema, wheezing, hypoxia or nausea/vomiting/diarrhea.
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| 45 | 2021-02-28 | burning sensation |
Hives and rash covering about 80% of body. Itching and burning sensation. Raised welts on torso, arm...
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Hives and rash covering about 80% of body. Itching and burning sensation. Raised welts on torso, arms, legs, back. No reaction on face or genitals. Occurred when I woke up on Saturday morning with only hives on arms. It spread throughout the day to cover the entire body. On Sunday body was covered in more hives. Took benedryl and Claritin starting day 1 of symptoms but it didn?t help. Continued to take. On Sunday evening took Pepcid AC. Starting to resolve as of Monday morning (now).
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| 45 | 2021-02-28 | cold extremities |
1. Diaphoretic 10 minutes after vaccine administration 2. Tongue swelling 3. Right arm cold and left...
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1. Diaphoretic 10 minutes after vaccine administration 2. Tongue swelling 3. Right arm cold and left arm hot 4. Throat tightening Was treated with Bendryl and EpiPen then sent to the ER
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| 45 | 2021-03-03 | discomfort |
Went into anaphylactic shock with 5 minutes. Throat started to itch, ears were popping and the left...
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Went into anaphylactic shock with 5 minutes. Throat started to itch, ears were popping and the left side of my face began to feel pressure. My wife injected me with my EpiPen. Within 10-15 minutes, the symptoms began to recede.
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| 45 | 2021-03-04 | pain in extremity |
Reported bruising and left upper arm pain which started on 3/3/2021 after receiving 2nd COVID-19 vac...
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Reported bruising and left upper arm pain which started on 3/3/2021 after receiving 2nd COVID-19 vaccine and persisted until 3/4/2021. Pain improved on 3/4/2021 but not resolved. Left upper arm/shoulder pain w/full ROM. Reported no side effects after 1st COVID-19 vaccine.
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| 45 | 2021-03-04 | tingling |
Complaint of "tingling" and "feeling" of edema in lips. Patient subsequently went to the bathroom t...
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Complaint of "tingling" and "feeling" of edema in lips. Patient subsequently went to the bathroom to see if his lips were swollen and they were not. Paramedic reported that the patient expressed anxiety about injections/needles and this may have contributed to perceived adverse effects. Patient asked for Benadryl and was given 25 mg po x 1.
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| 45 | 2021-03-05 | numbness |
I experienced numbness in the tip of my right pinky finger that I hadn?t noticed prior to the vaccin...
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I experienced numbness in the tip of my right pinky finger that I hadn?t noticed prior to the vaccine shot. I still have the numbness to this day. I don?t notice it unless I flick the right pinky fingertip with my right thumb. It seems to be the same amount of numbness during all these days, without change.
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| 45 | 2021-03-09 | bell's palsy |
Bell's palsy; This is a spontaneous report from a contactable consumer (patient's wife). A 45-year-o...
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Bell's palsy; This is a spontaneous report from a contactable consumer (patient's wife). A 45-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration on 02Feb2021 at 11:00 at a single dose on left arm for COVID-19 immunisation. Medical history included ongoing systemic lupus erythematosus (Lupus), ongoing hypertension (High Blood Pressure), ongoing gout and hip arthroplasty from Dec2020 to an unknown date; all diagnosed about 20 years ago. Concomitant medications included allopurinol, atorvastatin, benzonatate, chlorthalidone, apixaban (ELIQUIS), hydrocodone bitartrate, paracetamol (HYDROCODONE/ACETAMINOPHEN), hydroxychloroquine, iron, loratadine, losartan potassium, mycophenolate mofetil, omeprazole, paricalcitol, prednisone, spironolactone and valacyclovir [valaciclovir] and vitamin D NOS. The reporter's husband had a reaction to the vaccine. She was wondering if it is ok to have the second dose. He got paralysis, Bell's Palsy on 14Feb2021. She clarified vaccine as COVID19 Vaccine. She would like any information available about second dose after having Bell's Palsy with the first dose. The outcome of the event was not recovered.
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| 45 | 2021-03-10 | cold sweat, tremor |
Recipient reports feeling bad all over started immediately, shaking but waited in his car in the par...
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Recipient reports feeling bad all over started immediately, shaking but waited in his car in the parking lot after the 15 minute waiting period. Reported back into the vaccination site approx 45 minutes after his injection. Elevated BP 150/105, few minutes later was 170/110 hr 125 rr 20 skin clammy at intervals. Glucose 148 per his report from his insulin pump. No hypertension history or meds per his report.
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| 45 | 2021-03-10 | numbness |
Acute right index finger digital ischemia after initial complete numbness from PIP joint distally ab...
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Acute right index finger digital ischemia after initial complete numbness from PIP joint distally absent any previous symptoms ever. Recurrence Jan 20 of same symptoms. Suspect antibody complex clot blocking terminal branches of digital arteries.
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| 45 | 2021-03-10 | tremor, cold sweat |
Recipient stated began feel bad almost immediately after his injection, stayed 15 minutes and left v...
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Recipient stated began feel bad almost immediately after his injection, stayed 15 minutes and left vaccination area but waited in the parking lot and reported back into the vaccination clinic approx 45 minutes. Reported feeling very bad all over, trembling, glucose per his report of 148. skin was somewhat clammy to touch, bp 150/105 and 5 minutes later 170/110, hr 120s, rr 20, referred to PCP
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| 45 | 2021-03-12 | numbness, pain in extremity |
soreness to r arm that grew in intensity - while in pcp office, blood pressure was 154/106, hr was 1...
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soreness to r arm that grew in intensity - while in pcp office, blood pressure was 154/106, hr was 112 - at that time, on 3/8/21, I began to have numbness in my left thumb that went up my arm and into my face on the left side. At this time, they transported me to the ER, which is right across the street for evaluation and treatment. Mercy ER physician ran bloodwork, an ekg, and a shoulder xray. All tests had good results and I was later released with some medication.
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| 45 | 2021-03-12 | pain in extremity |
NEXT DAY STARTED GETTING COUGH, CONGESTION, DYSPNEA, MALAISE, LOSS OF TASTE, LEFT ARM PAIN. GRADUALL...
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NEXT DAY STARTED GETTING COUGH, CONGESTION, DYSPNEA, MALAISE, LOSS OF TASTE, LEFT ARM PAIN. GRADUALLY WORSENED, PERSISTING.
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| 45 | 2021-03-15 | cold extremities |
Left injection soreness (3/12/21) Right knee pain where replacement is (3/14/21). Right hip pain whe...
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Left injection soreness (3/12/21) Right knee pain where replacement is (3/14/21). Right hip pain where replacement is(3/14/21). Right scapular pain (3/14/21). Bilateral hand coldness (3/14/21. Taking Naproxen 220mg 1 tablet daily since 3/14/21.
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| 45 | 2021-03-16 | tingling |
Pt started to feel slightly lightheaded about 10 minutes after vaccination, then started to have som...
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Pt started to feel slightly lightheaded about 10 minutes after vaccination, then started to have some tingling in his face. He received 25 mg of oral diphenhydramine with good results within 30 minutes. Pt has a h/o anaphylaxis to allergy shots as a child one time, but then never had a reaction again.
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| 45 | 2021-03-16 | tenderness | Tenderness in eft hand, mainly pink and index fingers. |
| 45 | 2021-03-18 | nerve pain |
Beginning 6 days after 2nd vaccine dose, had one day of low grade fever (first day only), 2 days of ...
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Beginning 6 days after 2nd vaccine dose, had one day of low grade fever (first day only), 2 days of arthralgia of MCP and IP joints of hands, knees, ankles, MTP joints of feet; 4 days of peripheral worse than central neuralgia (mild on anterior torso and thighs, increased over both forearms and legs, and extreme/severe of hands & feet, with even light touch, clothes, bedsheets causing burning pain. Neuralgia responsive to Gabapentin, but not acetaminophen or ibuprofen. After 4 days of neuralgia resolved, then still had altered heat and cold sensation/perception for hands and feet (palms & soles more than dorsa) for 3-4 more days, but no pain.
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| 45 | 2021-03-18 | numbness and pain in extremities, nerve pain |
3 days after vaccination severe nerve pain and neuropathy; 3 days after vaccination severe nerve pai...
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3 days after vaccination severe nerve pain and neuropathy; 3 days after vaccination severe nerve pain and neuropathy; Low grade fever, under 100; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6202), via an unspecified route of administration, administered in left arm on 27Feb2021 at 12:00 PM (at age of 45 years old) at a single dose for COVID-19 immunization. Medical history included hereditary spastic paraplegia. No known allergies. The patient did not have COVID prior vaccination, also not tested COVID post vaccination. No other vaccine in four weeks. Concomitant medications included dextromethorphan hydrobromide, quinidine sulfate (NUEDEXTA), pregabalin (LYRICA), cetirizine hydrochloride (ZYRTEC), venlafaxine. On 02Mar2021 at 09:15 AM (3 days after vaccination), severe nerve pain and neuropathy occurred. Sensation common with my disorder, but never this severe. Affected arms and legs. Lasted about 18 after onset. Typical incident will last no more than an hour. Low grade fever, under 100. No treatment received. The outcome of the events was recovering.
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| 45 | 2021-03-21 | weakness |
After 2nd dose, I did not have a high fever but been fatigue and lightheaded/energy drained for 3 da...
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After 2nd dose, I did not have a high fever but been fatigue and lightheaded/energy drained for 3 days with heart palpitations like If I had OD on energy drinks. The symptoms disappeared on 4th and 5th but returned the 6th day morning ... feeling like I woke up after 2 tablets of Bynadril
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| 45 | 2021-03-25 | tingling |
After vaccine vaccination, patient has vasovagal syncope. Patient states swelling of tongue, blurry ...
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After vaccine vaccination, patient has vasovagal syncope. Patient states swelling of tongue, blurry vision, nauseous hands tingling, dizzy and lightheaded. Called code green, paramedics arrived. Laid patient down flat down on cot. Patient is stable. BP 106/67 98% o2sat HR 65 RR 16
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| 45 | 2021-03-26 | bell's palsy, facial paralysis, facial pain |
Right ear pain started on the Wednesday afternoon, two days after Vaccine shot. By Friday evening th...
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Right ear pain started on the Wednesday afternoon, two days after Vaccine shot. By Friday evening the ear pain was intense and it had moved below the ear to lymphnode area. Saturday, his ear was really swollen and red. He went to the Urgent Care and they prescribed an antibiotic Cephalexin thinking it could be some sort of ear infection or insect bite. Sunday morning he woke up with his face droopy. We tried to get an appt. with Urgent Care, but they sent us to the ER. The ER did a physical assessment and concluded he had an ear infection and Bells Palsy. The prescribed another antibiotic Doxycycline, an antiviral Famciclovir and a steroid of prednisone. By Monday he was extremely nauseas and had started having vertigo. We went to Urgent Care and they prescribed him Ondansetron for nausea and made the assessment that he had Shingles in his ear. We saw PCP on Wednesday and he assessed that this was a zoster ear infection causing facial paralysis and vertigo, also known as a rare condition called Ramsay Hunt Syndrome and that it was most likely attributed to his Covid vaccine shot and not to get the second vaccine shot. The Dr. took him off the antibiotics and put him on a higher dose of prednisone, a different antiviral (valacyclovir) and Meclizine for vertigo symptoms. He sent referrals for Neurology, ENT and Eye Dr. He saw the Neurologist that Friday and he concurred Ramsay Hunt Syndrome, most likley from Covid Vaccine and do not get the second vaccine shot. The neurologist referred him to Physical Therapy to treat his vestibular issues. He ordered an MRI and some blood work. We are still waiting for the results. We saw an ENT an he had him have a hearing test which showed moderate high frequency hearing loss. The ENT prescribed Gabapentin for the ear and face pain. He started to see a physical therapist this week, he had his MRI on Wednesday and we see the ENT again on Monday. He has no improvement yet, other than the nausea has subsided.
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| 45 | 2021-03-26 | flushing | Flushing; BP 147/97 (pulse 100), 97% O2 sat. Water and crackers given. |
| 45 | 2021-03-27 | bell's palsy, slurring, numbness |
Bells palsy- pain and pressure on rear left side of head and ear. Numbness on the left side of face ...
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Bells palsy- pain and pressure on rear left side of head and ear. Numbness on the left side of face ,jaw and tongue. Left eye does not blink so constantly tears, slurred speach and no taste. Symptoms started on 3/21/21 and got worse. Meds prescribed acyclovir 800mgs , prednisone 10mg and Diclofenac sod dr 75 mg for pain.
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| 45 | 2021-03-27 | feeling hot |
0950 pt reported feeling "hot and sweaty and dizzy " 10 minutes after receiving vaccine dose. Instru...
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0950 pt reported feeling "hot and sweaty and dizzy " 10 minutes after receiving vaccine dose. Instructed to lay down on floor as also reported "feeling like I am going to pass out". Pt placed on gurney via backboard and placed in Trendelenburg position. transported to medical observation area. vs taken upon arrival to medical observation BP 116/79 P 93 pox 95%, strong pulse, pallor noted. Pt stated "feeling better" and color improved to pink , strong pulse noted. Pt placed in supine position on gurney. 0958 Pt continued to improve with HOB elevated to 45 degrees and pt given graham crackers and 4 0z apple juice . BP 133/89 P 90 pox 95%. 1010 Pt reports feeling much better, drank 4 oz water and ate more graham crackers. Pt reported that he had not eaten breakfast and only drank a cup of caffeinated coffee prior to receiving vaccine. Reports "feeling much better" with the water , juice and crackers. BP 124/84 P 89 pox 97%. 1025pt sitting in chair and reportins feeling "back to normal" BP 125/84 P 83 pox 96%. Pt discharged with instructions to f/u with pcp if any other symptoms today. instructed to remain hydrated today and to eat healthy lunch and dinner.
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| 45 | 2021-03-28 | muscle spasms |
About 2 weeks after the first dose I started having muscle spasms in the left side of my face. Frequ...
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About 2 weeks after the first dose I started having muscle spasms in the left side of my face. Frequency has increased after the second dose.. Second dose was on: March 18 2021 Pfizer Lot: en6207 administered by injection in left arm no treatment or outcome has been pursued yet
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| 45 | 2021-03-30 | feeling hot, tingling |
I fainted about 5 minutes after the injection. When I awoke, my fingers tingled, I was hot, and my b...
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I fainted about 5 minutes after the injection. When I awoke, my fingers tingled, I was hot, and my breathing was labored.
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| 45 | 2021-03-30 | pain in extremity |
Within the first few day - typical AEs (low grade fever, sore arm, fatigue). However, the atypical ...
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Within the first few day - typical AEs (low grade fever, sore arm, fatigue). However, the atypical AEs included daily and persistent dizziness, "brain fog", fatigue, difficulty going up the stairs without getting winded (difficulty with physical exertion). These symptoms are still present on March 31st (11 days post injection). GI / diarrhea symptoms are also present. Of note, I did have COVID in the past (January 2021) - and had similar symptoms that had resolved at the time of the vaccine. These symptoms are severe enough that it may prevent the second shot (due to concerns of worsening AEs or prolonged events). Of note, the fatigue was worse with the actual disease vs. the vaccine.
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| 45 | 2021-03-30 | pain in extremity |
headache; left arm pain; chills; body aches; This is a spontaneous report from a contactable consume...
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headache; left arm pain; chills; body aches; This is a spontaneous report from a contactable consumer. A 45-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), via an unspecified route of administration, administered in Arm Left on 17Feb2021 11:30 (Batch/Lot Number: EL3247) as single dose for covid-19 immunisation. Medical history included irritable bowel syndrome and GERD (gastrooesophageal reflux disease) from an unknown date and unknown if ongoing. Concomitant medication(s) included probiotics taken for an unspecified indication, start and stop date were not reported; clotrimazole taken for an unspecified indication, start and stop date were not reported; diphenhydramine taken for an unspecified indication, start and stop date were not reported; colecalciferol (VITAMIN D) taken for an unspecified indication, start and stop date were not reported. The patient previously administered first of BNT162B2 (lot number :EL3247) on 27Jan2021 11:30 AM administered in Left arm for covid-19 immunisation. The patient experienced headache, left arm pain, chills and body aches on 17Feb2021 11:45. The patient did not received prior vaccination and covid tested post vaccination and also reported known allergies as no. Therapeutic measures were taken as a result of headache, left arm pain, chills and body aches and included treatment with acetaminophen 500 mg x 2 tablets. The outcome of the events was reported as not recovered.
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| 45 | 2021-03-31 | feeling cold, pain in extremity |
There were chills (like I was having a fever) at mid-night of the shot (shot was given in the mornin...
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There were chills (like I was having a fever) at mid-night of the shot (shot was given in the morning), to the extent that I was shivering. I had a low grade fever for most of the day. I measured it once and it came to 99F. I felt like I had a bad cold or mild flu. Symptoms prompted me to take the day easy (took off work and stayed in bed). Symptoms completely resolved by the next morning. I did not take any medication. I had no reaction to the first shot at all (besides a sore arm which was common for both shots)
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| 45 | 2021-03-31 | pain in extremity | Chills, Fever starting 12-13 hours after injection, lasting 8 hours. Sore arm. |
| 45 | 2021-04-01 | weakness |
10-12 hours after getting the shot I started to experience body aches, chills, and fever. These sym...
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10-12 hours after getting the shot I started to experience body aches, chills, and fever. These symptoms lasted through the night. The following day I felt better but had no energy. It was a one day thing. I've felt fine since then.
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| 45 | 2021-04-01 | discomfort, pain in extremity |
On the first dose I was very tired. On the second dose I had right arm pain for a day. Very heavy...
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On the first dose I was very tired. On the second dose I had right arm pain for a day. Very heavy.
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| 45 | 2021-04-01 | pain in extremity |
sore arm, brain fog, headache, swollen lymph nodes, pain in brain stem, sore neck, lethargy, diarrhe...
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sore arm, brain fog, headache, swollen lymph nodes, pain in brain stem, sore neck, lethargy, diarrhea, bowel discomfort, arthritis flare-up
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| 45 | 2021-04-03 | pain in extremity, numbness |
Within 3 minutes of receiving vaccine I had Instant fever, nausea, arm pain, face and lips numb, diz...
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Within 3 minutes of receiving vaccine I had Instant fever, nausea, arm pain, face and lips numb, dizziness, blood pressure low, chills. The pharmacy had to call 911 for a paramedic. I'm still feeling symptoms almost 24hrs later. I chose not to go to hospital in ambulance.
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| 45 | 2021-04-05 | numbness | Throat closure,, ears and face swelling, arm and leg numbness |
| 45 | 2021-04-07 | nerve pain | Acquired shingles including nerve pain and rash. Treating with antiviral (acyclovir) and gabapentin |
| 45 | 2021-04-09 | weakness |
Patient had generalized weakness, dizziness, fatigue, confusion, blurry vision, lethargy, neck pain ...
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Patient had generalized weakness, dizziness, fatigue, confusion, blurry vision, lethargy, neck pain 5 minutes after the first dose of Pfizer coronavirus disease vaccine. MRI C spine negative for COVID related transverse myelitis. CT head negative. His glucose was also low that was treated. He felt better the next day and was discharged.
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| 45 | 2021-04-09 | weakness |
Went to get up to get ready for work and instantly collapsed-scraping up knee. Became extremely naus...
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Went to get up to get ready for work and instantly collapsed-scraping up knee. Became extremely nauseous, weak, excruciating headache and dizzy. Unable to stand, had to crawl to nearby chair and call for wife. Thought might be dehydrated, extremely pale, tried to drink water, but began vomiting. BP was elevated, but no temperature. Tried to eat crackers and drink more water, but continued to violently vomit. Never felt so badly in entire life. No strength to stand or get up the stairs to be taken to ER, so had to call paramedics. When they arrived, BP had come down, but they felt needed to be transported to ER, so they took to healthcare facility at about 1:30 pm.
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| 45 | 2021-04-10 | feeling cold, slurring |
On initial assessment, client found sliding downwards from the chair, skin pale, diaphoretic, cool ...
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On initial assessment, client found sliding downwards from the chair, skin pale, diaphoretic, cool to touch, speech slurred. Client aroused to verbal stimuli. Client transferred to cot after ~ 15 seconds. Able to ambulate to observation with assistance.
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| 45 | 2021-04-10 | grand mal seizure |
I received the vaccine on 3/21. On 4/1 I had a breakthrough grand mal seizure walking down the stre...
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I received the vaccine on 3/21. On 4/1 I had a breakthrough grand mal seizure walking down the street after being seizure free for almost 5 years. The seizure resulted in a fractured vertebra (T12). On 4/5, while resting at home I woke up and had another seizure sitting in a relax the back chair. I had a mri on my brain that I understand came back normal. The doctors aren?t sure what caused the seizures but increased my dosage by 500 mgs per day despite my previous dosage controlling my seizures for about 5 years prior to my vaccine. No doctor has definitively stated the seizures were caused by the vaccine. However, the timing has prompted me to notify you of these events.
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| 45 | 2021-04-10 | muscle twitching |
One week after first dose, I began to experience slight muscle twitching in legs, arms, and torso. ...
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One week after first dose, I began to experience slight muscle twitching in legs, arms, and torso. The symptoms are not severe and I typically only feel them when at rest. I'm submitting in an effort to continue tracking data. Unless I hear otherwise, I plan to receive second dose next week.
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| 45 | 2021-04-11 | numbness |
The first night after the shot extreme stifles walk me up, It started at the upper sides of my calve...
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The first night after the shot extreme stifles walk me up, It started at the upper sides of my calves and quickly moved across the body, I would compare it after death rigor mortis, it went away but complete numbness in my right hand and arm stayed for the night. The next morning I got up with stiff legs but I was able to warm up and walk as normal. Right-hand numbness persisted for another 3 days. Now after a 6th it's getting to normal with occasional numbness in my right hand.
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| 45 | 2021-04-12 | flushing |
Light headedness and flush feeling to the face and left arm. Client seen and assessed by EMT and vi...
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Light headedness and flush feeling to the face and left arm. Client seen and assessed by EMT and vital signs are: BP 165/113, HR 98, O2 99. Client denies any other symptom and voiced that his BP is usually high and that there is no need for concern. Client advised to contact his PCP if symptoms worsen or go to ER. Client verbalized understanding and was cleared to go home by EMT once he stated he felt a decrease in sensation.
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| 45 | 2021-04-12 | pain in extremity |
first, 2 days arm soreness, the 4th 5th 6th continued, nausea throwing up, chills, chest and body pa...
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first, 2 days arm soreness, the 4th 5th 6th continued, nausea throwing up, chills, chest and body pain when coughing, headache, light shortness of breath.
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| 45 | 2021-04-13 | feeling hot |
I have been experiencing the subjective sensation internally of heat on the top of my ears and scalp...
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I have been experiencing the subjective sensation internally of heat on the top of my ears and scalp. My ears also feel warm to the touch compared to my fingers. Sometimes it makes me feel like the room is hot when I know it is not. This has been happening on and off for 6 weeks since shortly after my first shot.
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| 45 | 2021-04-13 | tingling, numbness |
Tingling mild numbness in my right cheek started 30 minutes after receiving the shot. Tingling subs...
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Tingling mild numbness in my right cheek started 30 minutes after receiving the shot. Tingling subsided/went away by 8pm that evening.
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| 45 | 2021-04-13 | tingling |
After receiving her vaccine client states she has tingling in both hands and nausea. Vital signs BP...
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After receiving her vaccine client states she has tingling in both hands and nausea. Vital signs BP 100/67, HR 67 O2Sat 96%. Client states she feels better. Client d/c home by EMS.
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| 45 | 2021-04-14 | numbness |
Pt felt SOB, c/o hand/lip numbness Vitals: 1400, HR 82, BP 198/118, O2 99, @1406 HR 80, BP 174/111...
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Pt felt SOB, c/o hand/lip numbness Vitals: 1400, HR 82, BP 198/118, O2 99, @1406 HR 80, BP 174/111, O2 100, @1419 HR 77, BP 166/97, O2 100 Pt discharged to home with others at 1432
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| 45 | 2021-04-15 | cold extremities, pain in extremity |
- In the early morning of 4/14/21 Pt called Kaiser help line complaining of cold hands/ feet, restle...
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- In the early morning of 4/14/21 Pt called Kaiser help line complaining of cold hands/ feet, restlessness, pallor, R arm pain. - Telephone visit 4/14/21 complained of chills, nausea, vomiting, abdominal cramping, diarrhea. Fluids and rest recommended. - 4/15/21 presented to Kaiser with chest pain, shortness of breath, abdominal pain. Diagnosed with late presentation of acute coronary syndrome / anterior ST elevation MI. Echo with low EF < 25%, LV apical thrombus - 4/16/21 heart catheterization showed 100% occlusion of LAD treated with PCI / DES x 2, IABP. Endotracheal intubation for respiratory failure.
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| 45 | 2021-04-15 | tenderness | Swollen lump and itching at injection site. Tender to the touch. |
| 45 | 2021-04-16 | pain in extremity |
Blood clots developed in the 3 arteries in my lower right leg, cutting off all blood flow below my a...
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Blood clots developed in the 3 arteries in my lower right leg, cutting off all blood flow below my ankle. Extreme pain in my calf, my foot immediately lost its color and no pulses could be detected in my ankle or foot. Rushed to ER by ambulance. Vascular surgeon diagnosed it as simultaneous arterial thrombosis in the posterior tibial artery, anterior tibial artery, and fibular artery of the lower right leg. Admitted to the ICU, treatment was heparin drip for 3 days until all 3 clots cleared and all foot pulses were detectable.
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| 45 | 2021-04-17 | feeling hot, tingling |
passed out; fingers were tingling on both hands; very hot and sweating; breathing was labored; very ...
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passed out; fingers were tingling on both hands; very hot and sweating; breathing was labored; very hot and sweating; This is a spontaneous report received from a contactable consumer (patient) . A 45-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) dose 1 via an unspecified route of administration, administered in Arm Left on 27Mar2021 (Batch/Lot Number: EP7533) as single dose (at the age of 45 years old) for covid-19 immunisation. The patient medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication(s) included magnesium citrate taken for an unspecified indication, start and stop date were not reported. It was reported that about five minutes after the shot, the patient passed out in the observation area. When he awoke, his fingers were tingling on both hands, a was very hot and sweating, and his breathing was labored. Events onset date was 27Mar2021. The patient received lactated ringers as treatment. The outcome of the reported events was recovered. Since the vaccination, the patient has not been tested for COVID-19.
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| 45 | 2021-04-17 | pain in extremity |
sore arm; muscle soreness; general fatigue; This is a spontaneous report from a non-contactable cons...
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sore arm; muscle soreness; general fatigue; This is a spontaneous report from a non-contactable consumer. A 45-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 22Mar2021 as single dose for COVID-19 immunization. Medical history included high blood pressure and cholesterol. Prior to vaccination, the patient did not diagnose with COVID-19. No allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. He experienced sore arm and muscle soreness and general fatigue on 22Mar2021. Since the vaccination, the patient has not been tested for COVID-19. No treatments were received. Outcome of the events was recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 45 | 2021-04-18 | weakness, feeling cold |
Around 09.50 at night, I started to feel chills and a feeling of cold for no apparent reason, and I ...
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Around 09.50 at night, I started to feel chills and a feeling of cold for no apparent reason, and I had to go to bed because I could barely stand. Once in bed, I began to feel severe back pain, headache, and a progressive increase in fever to 103.5. I was taking Tylenol during the night and trying to hydrate myself, since I perceived that due to the fever, I was sweating frequently. The next day I also had a fever and a severe headache, but I was able to rest well, and today, Monday, I am already without apparent symptoms, beyond a feeling of moderate weakness.
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| 45 | 2021-04-18 | tremor | metallic taste, hand tremor, slight throat tightness |
| 45 | 2021-04-19 | weakness |
Pt reports he felt weak and diaphoretic shortly after receiving vaccine. Denies dizziness or lighthe...
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Pt reports he felt weak and diaphoretic shortly after receiving vaccine. Denies dizziness or lightheadedness. Given water and crackers and transported to med obs #1 via wheelchair. Pt prefers to sit on side of bed, rather than lying down in stretcher. No s/s of distress noted. Pt reports resolution of symptoms. Registration called to bedside to schedule pt for second dose per his request, prior to d/c to home. VS are as follows: 1300: BP 145/95, HR 85, RR 17, O2 sat 96% on RA. 1305: BP 127/87, HR 79, RR 16, O2 sat 97% on RA; 1310: BP 137/94, HR 77, RR 17, O2 sat 97% on RA.
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| 45 | 2021-04-19 | cold sweat | clammy, feels like passing out, dizzy. Evaluated by EMS-Refusal to transport. |
| 45 | 2021-04-19 | discomfort |
SWOLLEN MOUTH, EVERY 4-6 HOUR LEFT SIDE LUNG DISCOMFORT BELOW THE RIB BUT ABOVE THE STOMACH. ULCER ...
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SWOLLEN MOUTH, EVERY 4-6 HOUR LEFT SIDE LUNG DISCOMFORT BELOW THE RIB BUT ABOVE THE STOMACH. ULCER LIKE PAIN AND DISCOMFORT EVERY 4-6 HOURS, LESS SLEEP LIKE 5 HOURS DAILY.
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| 45 | 2021-04-19 | migraine |
I suffer from Meniere's disease and have had 2 episodes over the past 6 months. Since the vaccine I...
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I suffer from Meniere's disease and have had 2 episodes over the past 6 months. Since the vaccine I've had several small episodes and two big episodes in the span of 2 weeks and ongoing. A big episode will knock me out for hours even up to a day. See symptoms below. Small episodes: Dizziness-feel tipsy Nausea Headaches Vomiting Big episodes: (includes small) Full vertigo, feels like I'm drunk and have trouble walking. Feels like room is spinning Migraines Pressure in my head makes me feel like a bobble head and wobbly This has affected my work. My doctor told me to report this to you. I got the 1st vaccine shot on 04/05/21. I suffer from Meniere's disease and have had 2 episodes over the past 6 months. Since the vaccine I've had several small episodes and two big episodes n the span of 2 weeks and ongoing. . A big episode will knock me out for hours even up to a day. See symptoms below. Small episodes: Dizziness Nausea Headaches Vomiting Big episodes: (includes small) Full vertigo, feels like I'm drunk and have trouble walking. Feels like room is spinning Migraines Pressure in my head makes me feel like a bobble head and wobbly My second does is scheduled for 04/26/21, should I take it?
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| 45 | 2021-04-19 | pain in extremity | Chills no matter how much clothing I had on. Also a strong stomach ache. Also a soar arm. |
| 45 | 2021-04-20 | numbness |
~2230 chest tightness/pain (unlike asthma) that radiated to neck and left arm with left arm numbness...
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~2230 chest tightness/pain (unlike asthma) that radiated to neck and left arm with left arm numbness, anxiety He had taken 325mg of ASA 4x that day d/t right shoulder pain from previous injury
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| 45 | 2021-04-20 | night sweats |
Day after shot, progressively felt sicker and more sore throught the day. Had a slight fever at 4 pm...
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Day after shot, progressively felt sicker and more sore throught the day. Had a slight fever at 4 pm. By 630 pm at a 102 fever. Very high blood sugars that I couldn't manage for the day. Night sweats and fever over night but fever broke by morning. Felt off on the third day. On the fourth day woke up with a locked neck which never happens and felt ill, tired, sore, had a cough and mild vertigo for next 4-5 days.
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| 45 | 2021-04-20 | pain in extremity | Intense nausea, fatigue, right arm pain and rash on both forearms |
| 45 | 2021-04-20 | pain in extremity |
Extreme pain at the injection site and upper arm. The injection site has hard knot and is a little ...
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Extreme pain at the injection site and upper arm. The injection site has hard knot and is a little swollen.
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| 45 | 2021-04-21 | pain in extremity | arm soreness and stiff neck 11 days after vaccination. |
| 45 | 2021-04-23 | hot flush |
Headache. Body aches. Hot/cold/freezing. Boiling eyeballs. Not able to sleep. Perfuse sweating. Dizz...
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Headache. Body aches. Hot/cold/freezing. Boiling eyeballs. Not able to sleep. Perfuse sweating. Dizzy. Nausea. Like bad flu symptoms, like the worst flu I have ever felt.
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| 45 | 2021-04-24 | pain in extremity |
#1 ...extreme fatigue, sleepiness, drowsiness. (several days) #2 mild low grain headache (3 hrs) #3 ...
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#1 ...extreme fatigue, sleepiness, drowsiness. (several days) #2 mild low grain headache (3 hrs) #3 mild nausea (short period) #4 sniffles... runny nose. #5 soreness on right arm I have a general negative disposition to the Pfizer vaccine, overall I felt much better before taking the vaccine then after. There are well defined 'side effects' that are notable. Overall feeling after the vaccine is unwell. (Nothing like the side effects for say the flu virus) The side effects are much more pronounced. The side effect that is/was most notable is fatigue and drowsiness. I've felt unusually fatigued and sleepy over the past few days with the severest fatigue occurring the day after taking the vaccine. (I've felt fatigue like symptoms over the past few days since taking the vaccine on 4/22.)
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| 45 | 2021-04-25 | pain in extremity | Outbreak of 3 cold sores on upper lip. Substantially sore arm. |
| 45 | 2021-04-25 | cold extremities |
No symptoms on day of vaccination. Day 1 following vaccination, tired. Day 2 following vaccination, ...
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No symptoms on day of vaccination. Day 1 following vaccination, tired. Day 2 following vaccination, diffuse rash on face, neck and chest. Day 3 following vaccination, rash worsening and spreading to arms; also cold feet, especially toes. Day 3, met with telehealth physician who prescribed prednisone 40 mg once daily for 5 days and diphenhydramine 50 mg TID.
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| 45 | 2021-04-25 | tremor | Fever; muscular pain; joint pain; fatigue; headache; pain in the eyes, shaking; sweetness; |
| 45 | 2021-04-26 | flushing, numbness |
numbness in the extremities. Dizziness and mild vertigo. Flushing about 5 minutes after vaccination....
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numbness in the extremities. Dizziness and mild vertigo. Flushing about 5 minutes after vaccination. symptoms resolved quickly and on there own . negative orthostatic Vitals- BP: 122/73 - HR:76 - RESP:14 - sp02: 98%
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| 45 | 2021-04-27 | discomfort |
Dull pain in injection shoulder two weeks after injection. Major discomfort. Unable to sleep comfort...
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Dull pain in injection shoulder two weeks after injection. Major discomfort. Unable to sleep comfortably. Advil doesn?t help. Ice has helped some.
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| 45 | 2021-04-27 | limb paralysis | Dizziness, left arm/leg loss of movement. Confirmed stroke |
| 45 | 2021-04-27 | pain in extremity | Splitting headaches, chills, fever, nausea, vomiting, soreness in left arm |
| 45 | 2021-04-28 | cold sweat |
After being seated for monitoring period after 2nd dose, patient was witness to loose consciousness....
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After being seated for monitoring period after 2nd dose, patient was witness to loose consciousness. When nurse arrived to assist patient, patient took a deep, snoring breath and regained consciousness. After being placed on monitor, patient noted to be bradycardic with HR as low as 36. Pulse palpable. O2 sats remained stable. BP noted to be 80 palp. Blood glucose level noted to be 91. Patient coloring noted to be very dusky originally and patient noted to be clammy. Patient oriented when regaining consciousness. O2 applied via nasal canula and HR returned to low 70's. Patient given Gatorade and monitored by EMS. Patient declined transport to hospital and left ambulatory without any lasting symptoms.
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| 45 | 2021-04-28 | migraine, hot flush, pain in extremity |
When I woke up the day after (Day #2) being given the vaccine I was extremely tired exhausted, I had...
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When I woke up the day after (Day #2) being given the vaccine I was extremely tired exhausted, I had intense chills and hot flashes. Never a fever. I felt nauseated. Completely lethargic. Muscle aches all over my body, was hard to move. I couldn't stay awake. My eyes hurt. I had intense migraines. And no appetite. My right arm hurt, but not as bad as many others' reported. I took ibuprofen to help, it didn't. I drank lots of water and gatorade zero for the electrolytes. It didn't help either. On day #3, this was when it got scary. The previous symptoms carried over, minus the nausea and I was able to be mobile (less lethargic). But something new started to happen. I took my dog out for a short walk, a slow pace, I am very athletic, and I had shortness of breath. I was winded from just walking slowly. Then the brain fog started to set in. This I hated the most. I wasn't able to comprehend things. I tried to assemble an item I bought from Amazon and it was extremely hard to follow simple instructions. I wasn't able to see clearly for some reason. And even comprehending emails that I was receiving was troublesome. I kept drinking water, and was able to eat a little. Had two more bottles of Gatorade Zero. On day 3, most of all the symptoms subsided except that I still got winded from movement. On day 4, I was fine.
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| 45 | 2021-04-28 | pain in extremity |
Upon awakening the morning of April 18, the day after the 2nd dose, I had severe muscle pain between...
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Upon awakening the morning of April 18, the day after the 2nd dose, I had severe muscle pain between my left shoulder blade and spine. The pain occasionally went away but always came back. Around April 22 or 23 the pain moved down to the underneath side of my left tricep just above the elbow, but still would occur at the original site on my back. By the 25th or 26th the pain had started occuring as well in my left pectoral muscle right at the breastbone. Now the pain migrates around all 3 areas and can occupy one or all sites simultaneously. The pain has subsided somewhat by the time I saw my primary. He prescribed icing the back 3 times a day and referred me to phys therapy. Phys therapist gave me stretching exercises
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| 45 | 2021-04-29 | seizure | Seizure brought in by adverse reaction to my seizure medication. |
| 45 | 2021-04-30 | seizure |
Patient suffered a seizure and pulmonary edema four days after receiving second Pfizer shot. He was ...
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Patient suffered a seizure and pulmonary edema four days after receiving second Pfizer shot. He was pronounced dead several hours later. Patient had no health issues and was 45 years old.
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| 45 | 2021-04-30 | tremor, tingling, muscle twitching, inability to speak, speech disorder |
stroke/mini stroke; he couldn't move/loss of motor function/movements were off; Loss of motor functi...
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stroke/mini stroke; he couldn't move/loss of motor function/movements were off; Loss of motor function including movement and speech/couldn't speak; head was very tingly; speech was not slurred but more like there was an impediment; he couldn't move his mouth properly, his tongue and the bottom of his jaw wasn't moving like he wanted it to; Caller states he thought he was going to die, his body was shutting down; behavior change; his legs are shaky; eyes feel a little dry; thumbs weren't working right; rule out MS or Parkinson's; rule out MS or Parkinson's; I have had some sort of off feeling in my head, occasionally worse than other days/feels like he has a really tight cap on his head; he was a little dry thought he may be dehydrated; very tired; pounding headache in the back of his head constantly; he was twitching; really off-feeling; digestive issues/digestive problems; eyes were real mucusy/First week mucous in my eyes/could be allergy; eyes were real mucusy/First week mucous in my eyes/could be allergy; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER2613), via an unspecified route of administration, administered in Arm Left on 25Mar2021 as single dose for COVID-19 immunization on an unspecified facility. There were no medical history. No known allergy. The patient had no health issues with any severity, he is pretty athletic, pretty healthy. The patient's concomitant medications were not reported. No COVID-19 prior to vaccination. On 26Mar2021, the patient had digestive issues/digestive problems, eyes were real mucus, first week mucous in my eyes which could be allergy which resolved on 01Apr2021. On 06Apr2021 08:00 the patient reported that he couldn't move/loss of motor function and movements were off but his cognitive functions were fine, loss of motor function including movement and speech/couldn't speak, had some sort of off feeling in my head, occasionally worse than other days/feels like he has a really tight cap on his head, suffered a stroke or mini stroke and was sent to the emergency room. On 06Apr2021 at unspecified time the patent couldn't move his mouth properly, his tongue and the bottom of his jaw wasn't moving like he wanted it to, head was very tingly, speech was not slurred but more like there was an impediment, very tired, pounding headache in the back of his head constantly, he was a little dry thought he may be dehydrated, he was twitching, really off-feeling, and states he thought he was going to die, his body was shutting down. On an unspecified date, the patient had eyes feel a little dry, thumbs weren't working right, his legs are shaky, and noticed behavior change. The patient was hospitalized for 3 days from 06Apr2021 to 09Apr2021 due to thought he was going to die, his body was shutting down, stroke/mini stroke, couldn't move his mouth properly, his tongue and the bottom of his jaw wasn't moving like he wanted it to, couldn't move/loss of motor function/movements were off, head was very tingly, speech was not slurred but more like there was an impediment, loss of motor function including movement and speech/couldn't speak. The patient underwent lab tests and procedures which included IGG antibody test: positive and IGM antibody test: negative both on 19Apr2021, computerised tomogram: showed nothing on 06Apr2021, echocardiogram: unknown result on unspecified date, magnetic resonance imaging brain: showed nothing both on an unspecified date in Apr2021 (not sure if 15Apr2021 or 16Apr2021) and on 07Apr2021, COVID-19 test: negative on 06Apr2021, repeat COVID-19 test: negative on 07Apr2021. Therapeutic measures were taken as a result of stroke/mini stroke, loss of motor function including movement and speech/couldn't speak have had some sort of off feeling in my head, occasionally worse than other days/feels like he has a really tight cap on his head which includes TPA and digestive issues/digestive problems were treated with high fiber diet. The outcome of the event he was going to die, his body was shutting down, stroke/mini stroke, he couldn't move/loss of motor function/movements were off, head was very tingly, speech was not slurred but more like there was an impediment, loss of motor function including movement and speech/couldn't speak, have had some sort of off feeling in my head, occasionally worse than other days/feels like he has a really tight cap on his head, very tired, pounding headache in the back of his head constantly was not recovered, for the events digestive issues/digestive problems, eyes were real mucusy/first week mucous in my eyes/could be allergy was recovered on 01Apr2021, while for the rest of the events was unknown. Caller states he has an appointment with a neurologist and he's trying to get it moved up. Caller states his doctor wants to do a lumbar puncture to rule out MS or Parkinson's that sort of thing. Caller states but at this point they are trying to rule things out. Caller states he doesn't have a family history of really either them. Caller states there was no diagnosis. Caller states the doctor said he was pretty sure its a stroke, mini stroke, but his general practitioner doesn't think its a mini stroke. Caller states the effects are so long going and they will improve and fall back and then the doctor also said at the fact that has been cognitively aware the whole time, so there's been no official diagnosis yet.
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| 45 | 2021-05-04 | weakness |
14 days after the vaccine I am feeling a bit better but still unusually tired. At first I was weak, ...
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14 days after the vaccine I am feeling a bit better but still unusually tired. At first I was weak, wobbly and tired, every day got a bit better, but I'm still feeling it as of today; 14 days after the vaccine I am feeling a bit better but still unusually tired. At first I was weak, wobbly and tired, every day got a bit better, but I'm still feeling it as of today; 7 days after my first Pfizer Covid vaccine I developed severe fatigue and moderate headache,14 days after the vaccine I am feeling a bit better but still unusually tired; 7 days after my first Pfizer Covid vaccine I developed severe fatigue and moderate headache; This is a spontaneous report from a contactable consumer (Patient). A 45-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number was unknown), dose 1 via an unspecified route of administration, in left arm (shoulder) on 16Jan2021 09:15 (at 45-years age) as single dose for covid-19 immunisation. Medical history was and concomitant medications were not reported. Patient was not allergic to medications, food, or other products. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 23Jan2021 06:00 7 days after first Pfizer Covid vaccine patient developed severe fatigue and moderate headache. 14 days after the vaccine he was feeling a bit better but still unusually tired. At first, he was weak, wobbly and tired, every day got a bit better, but he was still feeling it as of today. On 24Jan2021 patient underwent laboratory test that include post vaccination COVID-19 nasal swab test which results negative. The patient did not receive any treatment for the events. The event outcome was reported as resolving. Information on the lot/batch number has been requested. Follow-up (15-Apr-2021): This follow-up is being submitted to notify that the batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
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| 45 | 2021-05-07 | muscle spasms, cold sweat |
nearly fainted twice; I've been having weird pains in several spots inside my muscles all over the p...
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nearly fainted twice; I've been having weird pains in several spots inside my muscles all over the place in my legs, feet, arms, neck, chest, face and even my left hand ring finger tip. It's pain that is in spots, it feels; I've been having weird pains in several spots inside my muscles all over the place in my legs, feet, arms, neck, chest, face and even my left hand ring finger tip. It's pain that is in spots, it feels; pains in chest; catching my breath; very cold and clammy; This is a spontaneous report from a contactable consumer (the patient). A 45-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EW0169), via an unspecified route of administration, on 14Apr2021 at 11:30 (at the age of 45-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included cardiac disorder from an unknown date and unknown if ongoing, irregular heart beat and depression from an unknown date and unknown if ongoing. Concomitant medication included metoprolol (METOPROLOL) taken for an unspecified indication, start and stop date were not reported. The patient did not have any other vaccines within four weeks prior to the vaccination. The patient stated that when he first got the shot he actually nearly fainted twice and had to lay on the floor for a while. It was very scary, he thought he was going to die. He got very cold and clammy and had pains in chest and had a hard time catching his breath. They checked his vital signs a couple times and said they looked good. But he still felt sick and they said if he did not feel better soon they may have to call for an ambulance for him. Eventually he felt better enough to where he was able to get up off the floor and on handicap cart to drive out of there. Also, he's been having weird pains in several spots inside his muscles all over the place in his legs, feet, arms, neck, chest, face and even his left hand ring finger tip. It's pain that is in spots, it feels like mini-charley-horses that lasts anywhere from 20 something to 30 something seconds. Now it's mostly continuous pains in his thigh muscles between his legs. And a pain in one spot in his left arm bicep. This has been happening for days." The patient experienced "nearly fainted twice" on 15Apr2021 with outcome of not recovered, chest pain, got very cold and clammy and had a hard time catching his breath on 15Apr2021 with outcome of not recovered. He also reported that he has been having weird pains in several spots inside his muscles all over the place in his legs, feet, arms, neck, chest, face and even his left hand ring finger tip. it's pain that is in spots, it feels starting on 15Apr2021 with outcome of not recovered. The patient underwent lab tests and procedures which included unspecified investigation: myalgias on an unspecified date . Therapeutic measures (unspecified) were taken as a result of the events.
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| 45 | 2021-05-11 | bell's palsy |
Bells Palsy; This is a spontaneous report from a contactable consumer. A 45-year-old male patient re...
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Bells Palsy; This is a spontaneous report from a contactable consumer. A 45-year-old male patient received second dose of BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Right on 19Apr2021 at 14:30 (Batch/Lot Number: EW0161) as SINGLE DOSE for covid-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination and the patient has not been tested for Covid-19 since the vaccination. Medical history included Anxiety, depression and known allergies: Tree nuts. Concomitant medication included duloxetine (DULOXETINE), mirtazapine (MIRTAZAPINE), lamotrigine (LAMICTAL) and gabapentin (GABAPENTIN) all taken for unspecified indications, start and stop dates were not reported. The patient experienced bells palsy on 24Apr2021 at 19:00. Therapeutic measures were taken as a result of bell's palsy which included Prednisone and Valyacyclovir. The patient received first dose of BNT162B2 on 29Mar2021 (lot ER8730) at 15:30 administered to right arm. Outcome of the event was recovering. Follow up attempts needed. Further information is expected
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| 45 | 2021-05-14 | bell's palsy |
Diagnosed with Bells Palsy; This is a spontaneous report from a contactable consumer (patient). A ...
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Diagnosed with Bells Palsy; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 13Apr2021 15:00 (Lot Number: ER8737) as single dose for covid-19 immunisation. Medical history included ongoing high blood pressure. There were no known allergies. Concomitant medications included omeprazole; tizanidine; meloxicam and metoprolol all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient was diagnosed with bells palsy on 26Apr2021 08:00 with outcome of recovering. The event resulted in Doctor or other healthcare professional office/clinic visit.
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| 45 | 2021-05-19 | pain in extremity |
pain in his leg that felt like a clot; pain in his leg; This is a spontaneous report from a contacta...
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pain in his leg that felt like a clot; pain in his leg; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the right arm on Mar2021 at 11:15 (at the age of 45-years-old) as a single dose for COVID-19 immunization. Medical history included ongoing venous insufficiency since 2019. Concomitant medications were none. The patient did not receive any other vaccinations within 4 weeks of the vaccine. The patient stated that he received his first dose on 30Mar2021 or 31Mar2021. On an unspecified date, the next day after the first vaccination, the patient experienced pain in his leg that felt like a clot for the first week and a half to two weeks. Then, the patient got a little bit better, even though he had almost gone to the emergency room, but he got better after a couple weeks. The clinical outcome of "pain in his leg that felt like a clot " was resolved on Apr2021. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021507016 Same patient/drug, different dose/event
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| 45 | 2021-05-25 | muscle spasms |
From hospital discharge summary: "45 y.o. right-hand-dominant male who presents with few hours of i...
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From hospital discharge summary: "45 y.o. right-hand-dominant male who presents with few hours of improving left arm heaviness/left hand cramping in the setting of getting his second Pfizer COVID-19 vaccination in his right arm 3 days ago and 3 weeks of mildly increased exercise/intermittent fasting. The patient reports getting his first Pfizer COVID-19 vaccination on April 7, 2021. Reports some mild symptoms afterwards. Around that same time, the patient reports having a checkup with his primary care doctor that was notable for a cholesterol elevation to 200. This prompted him to try and lose weight including intermittent fasting and increase in exercise, especially for exercises and cardio. The patient reports approximately 20 pound weight loss over the past 3 weeks. 3 days ago, the patient reports getting his second Pfizer COVID-19 vaccination in his right arm. Reports fever (maximum 103 Fahrenheit) and mild headache the subsequent 2 days after the vaccine. Last night, the patient went to sleep on his left side at around 8 PM. He woke up at 4 AM with significant left arm heaviness and left hand cramping. He tried to massage his hand with some slight improvement of the symptoms but otherwise the symptoms persisted. Hence, this morning, he called his PCP, who told him to come into the ER for further evaluation. Here, the patient reports improving left arm heaviness/left hand cramping. He also does report family history of heart attack and an uncle at a similar age and massive heart attack of his grandfather in their 60s. He denies fever, anorexia, unexpected weight change, headache, blurry vision, sinus pressure, cough, hemoptysis, orthopnea, PND, SOB, DOE, chest pain, pleurisy, changes in taste/smell, N/V/D, abdominal pain, flank pain, urinary sxs, genital sxs, black stools, incontinence, absence of flatus, calf pain, leg swelling, numbness/tingling, streaking redness/rash/skin changes, easy bruising. Also, deny history of HTN, DM, smoking, prior MI, prior PCI, prior CABG, prior TIA/CVA, or history of PAD. Further, denies recent trauma/fall, history of cancer, blood thinner use, recent drug use, recent travel, sick contacts, family history of connective tissue disease/congenital aortic anomaly, or family history of similar sxs. --- Hospital Course by Problem # Troponinemia (Likely myopericarditis) The patient has a family history notable for MI and CABG in relatives aged 50-70 on his mother's side. The patient notes that most of these family members were heavy smokers and drinkers, which he is not (never-smoker, rare EtOH, never illicit drugs). His symptoms are notable for L arm heaviness/cramping that began around 8pm on 4/30/21 at 9/10 severity and subsequently was 3-4/10 severity on presentation to ED and is 0-1/10 severity at time of admission to the floor; he has no associated numbness, weakness, coolness, or pallor. His symptoms are non-exertional. He denies CP, SOB, lightheadedness, nausea, jaw pain, abdominal pain, fatigue. He noes that he recently got the second COVID shot in the R arm, and had a post-vaccine course notable for Tmax 103 ~3d ago and 101 as recently as yesterday. His EKG was notable for ST-elevation in II/III/aVF and his troponins were elevated 305 -- > 298 -- > 328. Of note, his CRP was elevated at 69. The patients symptoms and findings could certainly be compatible with atypical ACS and, given the low risk of bleeding associated with heparin, he was treated conservatively upon admission with heparin infusion, metoprolol tartrate 6.25mg q6h, atorvastatin 80mg (he received ASA 325mg in the ED). However, given his recent covid vaccination and elevated CRP and reported fevers, this could also be compatible with myocarditis or other inflammatory etiology. TTE on 5/3 demonstrated preserved EF 55% with no WMA. Given reassuring TTE, a cMRI was ordered to assess for myocarditis vs scar tissue from recent ischemic event. Cardiac MRI on 5/5 was notable for finding consistent with myopericarditis (see below). Aspirin and atorvastatin was stopped on discharge. Patient was discharged with metoprolol 25 mg daily."
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| 45 | 2021-05-25 | nerve pain |
Significant increase in neuropathic pain lasting over 45 days. Breathing difficulties, daily nausea...
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Significant increase in neuropathic pain lasting over 45 days. Breathing difficulties, daily nausea episodes, upper right abdominal pain, muscle weakness, increased pain to all areas below T6, inability to breath without pain. Fatigue. Lasted acutely for over 30 days. Symptoms including breathing difficulty, nausea, and increased peripheral nerve pain continue to linger.
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| 45 | 2021-05-25 | pain in extremity | Sore arm, Fever, fatigue, headache, treated with Advil/Tylenol, ok by next morning. |
| 45 | 2021-05-25 | pain in extremity |
Sore Arm; This is a spontaneous report from a contactable consumer. (patient) A 45-year-old male pat...
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Sore Arm; This is a spontaneous report from a contactable consumer. (patient) A 45-year-old male patient received bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE), dose 2 via an unspecified route of administration in the left arm on 19Feb2021 11:15 A.M (Batch/Lot Number: En6200) as 2ND DOSE, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was not diagnosed with Covid-19 prior to vaccination. The patient has no known allergies. The patient received 1st dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE) at vaccination age of 45-year-old on 29Jan2021 (lot number: En5318) at 11:00 AM for covid-19 immunisation. The patient did not receive other vaccine in four weeks. On 19Feb2021 04:00 PM, the patient had a sore arm. No treatment was received for the adverse event. The patient has not been covid tested post vaccination. The outcome of the event was recovered on an unspecified date in 2021. No follow-up attempts are possible. No further information is expected.
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| 45 | 2021-05-25 | seizure, cold extremities |
A little more than 5 minutes after receiving shot had a seizure. Told me his wife he didn't feel rig...
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A little more than 5 minutes after receiving shot had a seizure. Told me his wife he didn't feel right and hands were very sweaty cold his eyes rolled back in head. Lost his color loss control of bodily functions( urine). Throwing up hard. EMT were called vitals were alright. Once we were home vomiting subsided and he slept hard.
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| 45 | 2021-05-26 | numbness, speech disorder, weakness, tingling |
cannot talk properly; his body and mind are responding slow; It affected him and he didn't know a ca...
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cannot talk properly; his body and mind are responding slow; It affected him and he didn't know a car was coming and didn't even see them; Not able to make good decision/made the wrong decision; weak when he walks and knees are bending; left side very slow and weak, unable to use left side; weak; could not stand up or be on his feet/ left side weak an unable to stand or walk; cannot type on the keyboard; fell on the floor; numbness on his left hand/numbness and tingling in hand; tingling in hand/numbness and tingling in hand; This is a spontaneous report from a contactable consumer (Patient, self-reported) via medical information team. A 45-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ER729; Expiration Date: 31Jul2021), dose 2 via an unspecified route of administration, administered in Hand Left (shoulder) on 10Apr2021 12:00, as 2ND DOSE, 0.3 ML SINGLE; for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine includes dose 1 (Batch/Lot Number: EP75334, Expiration Date: 31Jul2021), via an unspecified route of administration, administered in Hand Left (shoulder) on 20Mar2021 02:30PM, as 1ST DOSE, SINGLE. It was reported that patient received the second dose of the Pfizer Covid-19 vaccine on 10Apr2021 and he started experiencing numbness on his left hand and next morning he could no feel anything on the left side of his body, it was so weak that he could no lift his hand, walk on stand on his feet. He went to the ER, they made some tests, but primary care doctor did not provide a diagnosis. He started feeling better but today he could not stand up or be on his feet, he cannot talk properly, cannot type on a keyboard and the left side of his body is very slow and weak. Reportedly, the primary care provider was not able to provide him with any diagnosis. He was feeling better, but today, he noticed that he was not able to stand up on his feet again. He cannot talk properly due to weakness. He cannot type on the keyboard. The left side is very slow and very weak. It has been several weeks and he is not feeling better. Stated that he is 46 and was 46 when he experienced these events. Last week, patient went to the neurologist and no one had helped him. The only thing was about the side effects and were not telling him how that can be fixed. Numbness in hand has been more than 2 weeks. He doesn't feel numbness now but is very weak. The left side of his body has less strength. The numbness was minutes after the shot and the tingling was immediately after. The numbness and tingling lasted 30 to 40 minutes after the shot. The emergency doctor gave him some medicine but he does not remember what medicine. They also gave him fluids and then he got some strength. Woke up the next day and was unable to stand. He tried to go to the restroom and was so weak, he fell on the floor. They did all the tests and could not find anything. He is still not feeling normal. His right hand is fine. The left side, where they did the shot had less strength. He can't even move his finger properly and can't type on the keyboard, from the left hand side. if there are any cases like this and how that person got better and what was the root cause. So many weeks, this has been affecting his day to day life. He can not work. He is a software programmer. He needs to use his hands. He can't use his hands. Is feeling like his body and mind are responding slow. When he drives, he is not able to make good decisions. One time he really made the wrong decision. It affected him and he didn't know a car was coming and didn't even see them. States that he spoke to medical information, they could not provide any medical advice. Everyone is making this hard. They could not find another person with similar symptoms. Patient did not receive other vaccine in four weeks of vaccination. On an unspecified date, the patient experienced cannot talk properly, on 10Apr2021 12:05, numbness on his left hand/numbness and tingling in hand, 12:01 tingling in hand/numbness and tingling in hand, on 11Apr2021 weak, could not stand up or be on his feet/ left side weak an unable to stand or walk (was reported as worsened), fell on the floor, cannot type on the keyboard, weak when he walks and knees are bending, left side very slow and weak, unable to use left side, on an unspecified date his body and mind are responding slow, it affected him and he didn't know a car was coming and didn't even see them, not able to make good decision/made the wrong decision. Patient went emergency room on 11Apr2021 they made some tests, but primary care doctor did not provide a diagnosis. Patient was sent home to recover at home. wife was with him and brought him home. They gave him medicines and fluids. He was able to walk and stand up and somehow was recovering well. The patient underwent lab tests and procedures which included blood test: didn't find anything, nothing significant, electrocardiogram: didn't find anything, nothing significant, laboratory test: didn't find anything, nothing significant on an unspecified date. Therapeutic measures were taken as a result of left side very slow and weak, unable to use left side (asthenia). Outcome of the events numbness on his left hand/numbness and tingling in hand and tingling in hand/numbness and tingling in hand was recovered on 10Apr2021 12:45; left side very slow and weak, unable to use left side was not recovered and other events outcome was unknown. Follow-up attempts are needed. Further information is expected.
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| 45 | 2021-05-27 | unresponsive to stimuli, seizure |
Approximately 5 minutes after administering the vaccine, he was waiting in his car with a friend, He...
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Approximately 5 minutes after administering the vaccine, he was waiting in his car with a friend, He became unresponsive and appeared to have lost consciousness. Upon arrival to the vehicle he looked to be having a seizure. Did not respond to verbal commands but did respond to sternal rub. EMS called. BP 118/58 and pulse 60. He was diaphoretic and pale. EMS arrived and during their interview he had another more intense and longer seizure. Transported to the Emergency Room.
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| 45 | 2021-05-30 | weakness |
Bowel discomfort and stuffed right ear, partial hearing loss, vertigo, nausea, shingle like rash on ...
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Bowel discomfort and stuffed right ear, partial hearing loss, vertigo, nausea, shingle like rash on right side of the body. Treated with antibiotic and beclomethasone , seems to help with vertigo. vertigo came back one week later after finishing the antibiotics round. now on 30 days round of doxycycline, no vertigo , very little dizziness and nausea. 2 weeks back started a high dose of vitamin C that it seems to help with the dizziness and nausea. Right ear still stuffed and feeling weakness from time to time.
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| 45 | 2021-05-31 | pain in extremity |
On April 7, I received the first Pfizer vaccine, on April 9 my left knee started to hurt, on April 1...
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On April 7, I received the first Pfizer vaccine, on April 9 my left knee started to hurt, on April 10 I had to go to an urgent care because my left knee hurt and I was limping, on April 11 In April I went to the emergency room because I had a very strong pain in both legs, I could not walk and a severe headache, I also had a fever. On Monday the 11th they operated on my left knee because there was a lot of inflammation, that same day the second knee became inflamed, I was hospitalized from April 11 to 17 with a lot of pain in both legs. On April 21 I continued with a lot of pain and swelling in both legs and even in the ankles there was swelling. A rheumatologist doctor, because of the laboratory tests she conducted, did come to the conclusion that it was reactive arthritis caused by the Pfizer vaccine. Today June 1, 2021, I still have pain in both knees and ankles, especially the right one, both knees and the right ankle are a little swollen, until May 24 I walked with a walker and I did it with too much pain.
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| 45 | 2021-06-01 | weakness | dizziness, nausea, weakness, fatigue, cough, headache |
| 45 | 2021-06-01 | pain in extremity, numbness |
Shortness of breath when physically active. Chest pains, pain / numbness in arms. Elevated Blood Pre...
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Shortness of breath when physically active. Chest pains, pain / numbness in arms. Elevated Blood Pressure, sweating, light headedness, dizziness, nasuea.
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| 45 | 2021-06-01 | pain in extremity |
Pt called call center reporting left arm pain after he got Ist dose covid vaccine started since 04/2...
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Pt called call center reporting left arm pain after he got Ist dose covid vaccine started since 04/28 not getting better. Denies left arm swelling,redness or loss of sensation. Pt stated he got swollen roof of mouth at vaccination site after he got first dose covid vaccine,MD evaluated him at site and took bendaryl as per onsite MD recommendation wiith relief. Still slight swelling of palate there but much better than before, pt speech clear,denies sob or any emergency sx. MD appt scheduled for patient and ED precautions provided to patient
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| 45 | 2021-06-03 | pain in extremity, weakness |
Arm soreness; Low grade fever; Headache; Body fatigue; Weakness; Dizziness; Chills; This is a sponta...
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Arm soreness; Low grade fever; Headache; Body fatigue; Weakness; Dizziness; Chills; This is a spontaneous report from a non-contactable physician, the patient. A 45-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 17Mar2021 at 15:00 (at the age of 45-years-old), as a single dose for COVID-19 immunisation. The patients medical history was not reported. The patient did not receive any concomitant medications within two weeks prior to the second dose of vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 23Feb2021 at 14:45 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 18Mar2021 at 05:00, the patient experienced weakness, dizziness, arm soreness, low grade fever, headache, body fatigue and chills. The patient did not receive any treatment for the events. The clinical outcome of the events weakness, dizziness, pain in arm, low grade fever, headache, fatigue and chills were recovering. Information about lot/batch number cannot be obtained. No further information is expected.
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| 45 | 2021-06-03 | pain in extremity |
Sore arm; Fever; body aches; chills; This is a spontaneous report from a contactable consumer or non...
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Sore arm; Fever; body aches; chills; This is a spontaneous report from a contactable consumer or non-health care professional (patient). A 45-year-old male patient started to receive first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EN6203) via an unspecified route of administration and administered in Left arm on 05Mar2021 at 09:00 am as single dose for COVID-19 immunization. The patient experienced COVID-19 prior to vaccination and not tested post vaccination. The patient didn't receive any other vaccine in four weeks. The patient medical history and concomitant medications were not reported. On 06Mar2021, at 03:00 am the patient experienced Sore Arm, Fever, body aches and chills. The patient did not receive any treatment for events. The outcome of events was not resolved. No follow-up attempts are possible. No further information is expected.
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| 45 | 2021-06-03 | pain in extremity |
muscle pain; joint pain; headache; fever; injection site swelling; nausea; diarrhea; vomiting; arm p...
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muscle pain; joint pain; headache; fever; injection site swelling; nausea; diarrhea; vomiting; arm pain; This is a spontaneous report from a contactable consumer reported for himself. A 45-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 19May2021 (at age of 45 years old) 09:00AM (Lot Number: EW0179) as 1st dose, single for covid-19 immunisation. Medical history included covid-19, No known allergies. The patient's concomitant medications received within 2 weeks of vaccination were none. The patient experienced muscle pain, joint pain, headache, fever, injection site swelling, nausea, diarrhea, vomiting and arm pain, all on 19May2021 11:00 PM, no treatment received for events, and patient was not recovered from events. Adverse events result in Congenital anomaly or birth defect and Seriousness criteria reported as Congenital anomaly/birth defect (pending clarification). Prior to vaccination, the patient was diagnosed with COVID-19, Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No follow-up attempts possible. No further information expected.
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| 45 | 2021-06-07 | coordination abnormal, speech disorder |
1 day after receiving vaccine I experienced "brain fog". Approximately 10 days afterwards (around 2...
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1 day after receiving vaccine I experienced "brain fog". Approximately 10 days afterwards (around 2/25), I experienced symptoms of a minor stroke - I experienced lack of coordination in typing and later that evening experienced difficulty with speaking and comprehension, but only for a few minutes. A few days later, that weekend, I had some issues playing songs on the piano I had played before, making a lot of mistakes. About another 2 weeks afterwards, on 3/9/2021, I experienced more symptoms of stroke. For most of the day I had issues with typing, and later that evening I had some coordination issues with closing a soda bottle. On the morning of 3/10/2021, I continued to experience issues with typing and also had difficulty speaking and understanding my wife. At this point I went to the emergency room and was found/diagnosed to have experienced multiple TIA strokes.
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| 45 | 2021-06-08 | pain in extremity |
mild headache; Sore arm 11 hours post-vaccine; more tired than normal that evening; This is a sponta...
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mild headache; Sore arm 11 hours post-vaccine; more tired than normal that evening; This is a spontaneous report from a contactable consumer. A 45-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EN 6199) via an unspecified route of administration administered in right arm on 09Mar2021 09:45 (at 45 years old) as single dose for COVID-19 immunization. There were no other vaccinations within 4 weeks prior to the first dose of BNT162B2. Medical history included high blood pressure, acid reflux, fatty liver, and overweight; all from unspecified date and unknown if ongoing. Concomitant medications included unspecified blood pressure and acid reflux medicines. The patient did not have COVID prior vaccination and no COVID tests done post vaccination. The patient experienced sore arm 11 hours post-vaccine and more tired than normal that evening on 09Mar2021. The patient also experienced mild headache the next morning on 10Mar2021. All were non-serious. No treatment was given due to the events. Outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
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| 45 | 2021-06-09 | numbness |
Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Numbness (sp...
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Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Numbness (specify: facial area, extremities)-Severe, Additional Details: numbness on left side from neck to toes. did not go away for days
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| 45 | 2021-06-10 | cold sweat |
I almost got fainted or black out; My blood pressure and heart rate dropped to 76/55/42 respectively...
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I almost got fainted or black out; My blood pressure and heart rate dropped to 76/55/42 respectively; My blood pressure and heart rate dropped to 76/55/42 respectively; Sweaty; Clammy; This is a spontaneous report from a contactable consumer. This 45-year-old male consumer (patient) received the first dose of bnt162b2 (BNT162B2), via an unspecified route of administration administered in arm right on 27May2021 12:26 (Batch/Lot Number: EW0180) as single dose for covid-19 immunisation. There was no medical history or concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient received first Pfizer dose in his right arm at 12:26 PM on 27May2021. even minutes after vaccination, at 12:33 PM, he almost got fainted or black out. His blood pressure and heart rate dropped to 76/55/42 respectively. The patient was sweaty and clammy for about 3 minutes. At 12:40 PM, his blood pressure and heart rate elevated to 103/69/65. At 1:05PM, his blood pressure and heart rate came back to normal 120/84/67. The patient drove home afterwards without further reaction. He was a heathy male with no underline health condition. The patient have been testing for COVID-19 once a week since 07May2021 and all test results came back negatives (on 28May2021). The events result Doctor or other healthcare professional office/clinic visit, Life threatening illness (immediate risk of death from the event). The outcome of blood pressure and heart rate dropped was recovered on 27May2021 1:05PM, of other events was recovered in May2021. No treatment was received for the events.
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| 46 | 2021-01-03 | tingling, numbness |
He stated he was fine for 20 minutes after the administration, but noticed driving home that the lef...
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He stated he was fine for 20 minutes after the administration, but noticed driving home that the left side of his face felt funny/tingly. He says it progressed that evening to numbness and states his spouse noticed slight swelling to his face. He also complained of pain to his teeth and gums. He voiced concerns about bell's palsy, but stated he didn't notice any asymmetry or paralysis in his face and his symptoms have resolved entirely as of today 1/4. He was never seen or evaluated while he was having symptoms, unfortunately, and was able to continue working. Denied chest pain or difficulty breathing, no rash. He reports self-medicating with prednisone on sat/sun with improvement and as mentioned, is now asymptomatic.
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| 46 | 2021-01-04 | weakness |
No immediate reaction within 15 minutes of injection. Increasing injection site pain throughout the ...
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No immediate reaction within 15 minutes of injection. Increasing injection site pain throughout the day with mild chills and nausea starting around 7:00 pm (Approx 11 hrs after injection). Chills steadily intensified, with fever beginning, became severe over the next 2-3 hours, and persisted throughout the night. Along with the fever/chills & nausea, there was also moderate muscle/joint pain (mainly neck and back), moderate to severe fatigue and weakness, weird freaky dreams, restlessness, and moderate headache. Symptoms started to relent around 6:00 am the morning after injection, however fatigue/weakness, nausea, and mild fever/chills have persisted throughout the day with minimal improvement.
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| 46 | 2021-01-04 | burning sensation, weakness |
Severe allergic reaction; BP of 170/104; felt like his whole body was on fire; chest tightness; HR e...
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Severe allergic reaction; BP of 170/104; felt like his whole body was on fire; chest tightness; HR elevated at 110bpm; Severe allergic reaction with symptoms that include/ rash all over his body including his throat, chest, and inner legs.; Right side of neck was swollen and sore; Right side of neck was swollen and sore; his neck was stiff to turn; he feels "really weak and tired"; he feels "really weak and tired"; This is a spontaneous report from a contactable other healthcare professional. A 46-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date unknown) via an unspecified route of administration, on 29Dec2020, at a single dose, for COVID-19. The patient's medical history and concomitant medications were not reported. Patient is a 46y/o male certified nursing assistant (CNA). He received his first dose of Pfizer-Biontech Covid19 vaccine, yesterday 29Dec2020. On an unspecified date in Dec2020, patient experienced severe allergic reaction with symptoms that include: felt like his whole body was on fire, chest tightness, BP of 170/104, HR elevated at 110 bpm, rash all over his body including his throat, chest, and inner legs. Right side of neck was swollen and sore. Both sides are swollen, today, and his neck was stiff to turn, he feels "really weak and tired". Patient was taken by ambulance to the emergency room. Patient then asked if he should get the second dose of the vaccine. Outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of severe allergic reaction with multiple symptoms cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 46 | 2021-01-07 | feeling cold | Chills, body aches, head aches,fever and felt dizzy |
| 46 | 2021-01-07 | tingling |
Following administration of COVID-19 vaccine, patient experienced "tingling in throat and lower legs...
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Following administration of COVID-19 vaccine, patient experienced "tingling in throat and lower legs" plus dizziness. After monitoring for 30 minutes, patient reported symptoms started to resolve. Upon follow-up, patient reported that tingling in lower legs had resolved after 3 days.
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| 46 | 2021-01-08 | cold sweat |
Headache, SkinRash & Rash Narrative: Had to go to the ER, started with a rash all over his body an...
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Headache, SkinRash & Rash Narrative: Had to go to the ER, started with a rash all over his body and itchiness, was given Prednisone and Benadryl, and today feels like he has a headache. Also feels clammy. Meds given in ER helped the rash some, less reddened today.
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| 46 | 2021-01-08 | tingling |
c/o tingling in both hands, light headed, profuse sweating and color pale. 120/68, 83, 28, 98%O2 sat...
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c/o tingling in both hands, light headed, profuse sweating and color pale. 120/68, 83, 28, 98%O2 sat. T 97.7 Narrative: c/o tingling to both hands, light headedness, profuse sweating, and color pale. 120/68, 83, 28, 98%O2 sat.; 122/62, 84, 24, 98% O2sat.; 119/60, 82, 20, 97% O2sat. ; at discharge 125/88, 78, 18, 98% O2 sat.. 09500: Recovered and "feeling better."
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| 46 | 2021-01-08 | tingling |
Patient received 2nd dose of Pfizer covid vaccine. Began to complain of dizziness and tingling in ex...
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Patient received 2nd dose of Pfizer covid vaccine. Began to complain of dizziness and tingling in extremities. 1234- 166/95 hr 72 98% 1239- 146/106; 1242- 180/103 1247- 160/98 1317- 168/96 1325- 142/97 1255- Called Dr. Patient given 25mg benadryl PO per MD orders. Patient transported to ED by wheelchair
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| 46 | 2021-01-09 | cold sweat |
Headache, full body aches, fatigue, cold sweats/chills, increased urine output and frequency. Treate...
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Headache, full body aches, fatigue, cold sweats/chills, increased urine output and frequency. Treated with rest, acetaminophen for pain, fluid replenishment.
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| 46 | 2021-01-10 | cold sweat, pain in extremity |
Saturday all day my arm hurt. Sunday I woke up with no arm pain. Then after eating lunch I had diarr...
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Saturday all day my arm hurt. Sunday I woke up with no arm pain. Then after eating lunch I had diarrhea consistently and increased. Woke up in the middle of the night with more diarrhea and cold sweats. Temp 93.4. Sugar 112 in the middle of the night. I feel completely like trash, feel sick all over. Stomach hurts and lots of gas and diarrhea consistently.
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| 46 | 2021-01-10 | feeling hot | HEAVY WARMTH FEELING IN EXTREAMITIES |
| 46 | 2021-01-11 | facial pain, facial paralysis |
patient developed acute onset of right-sided facial palsy and pain; patient developed acute onset of...
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patient developed acute onset of right-sided facial palsy and pain; patient developed acute onset of right-sided facial palsy and pain; Brain MRI done showing T2 hyperintensity in the brainstem and basal ganglia, suspicious for inflammation; This is a spontaneous report from a contactable physician. A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), on 18Dec2020 at SINGLE DOSE for COVID-19 immunization. Medical history included psoriasis. No COVID prior vaccination. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine.No known allergies. Concomitant medications (received within 2 weeks of vaccination) included fluoxetine. days following vaccination,on 23Dec2020,the patient developed acute onset of right-sided facial palsy and pain. Brain MRI done showing T2 hyperintensity in the brainstem and basal ganglia, suspicious for inflammation. Work-up is ongoing. AE Resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage].It was unknown if the event was treated. The event was assessed as serious for Disabling/Incapacitating. The patient had been tested for COVID post vaccination (covid test result-Negative). The outcome of the events werenot recovered Information about lot/batch number has been requested.; Sender's Comments: A possible causal relationship between acute onset of right-sided facial palsy and pain with MRI findings suspicious for brain inflammation and BNT162B2 cannot be completely ruled out considering the temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 46 | 2021-01-11 | facial paralysis, bell's palsy |
Sun 10pm change in taste. Taste continued all day Tuesday. Had COVID test done. It was negative. Tha...
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Sun 10pm change in taste. Taste continued all day Tuesday. Had COVID test done. It was negative. That evening his eye started blinking.... Bells Palsey. Difficulty with face movement. Today still persisting. Now taking a steroid. He is a MD.
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| 46 | 2021-01-11 | cold extremities | Cold extremity below injection site |
| 46 | 2021-01-12 | facial pain, facial paralysis |
Within 5 days of vaccination, he developed severe right-sided facial pain, and about two days later ...
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Within 5 days of vaccination, he developed severe right-sided facial pain, and about two days later developed complete right-sided facial paralysis. In the following days he also developed balance problems and nausea/vomiting. His facial pain has begun to improve with high-dose prednisone.
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| 46 | 2021-01-14 | pain in extremity |
feeling "not quite right"; nausea; headache; arm was sore/ it felt like someone shot him in the arm;...
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feeling "not quite right"; nausea; headache; arm was sore/ it felt like someone shot him in the arm; This is a spontaneous report from a contactable consumer. A 46-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EL0140), via an unspecified route of administration on 24Dec2020 10:00 at SINGLE DOSE at left arm for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. On 31Dec2020, the patient experienced headache, "lungs felt uber clean and clear," and nausea. The patient stated about a week afterward he started feeling "not quite right" He stated his arm was sore for about 12 hours after the shot, but this has resolved. He has already seen his PCP, lungs are clear, and Covid test was negative. He said that a week ago, he started to feel not quite right. He said that his lungs felt uber clean, but stated that he had a headache and nausea every now and then. He was wondering if it is related to the vaccination. He said that he went to the doctor and his O2 sat was 99% and she did not even think he needed a Covid test, but the rapid test was Covid negative. He stated that on the website that it says that up to 7 days after vaccination 77% of people reported fever, chills, headache and other symptoms. He said that he did not know that you could experience side effects a week after getting a vaccine. He said that his eases his mind a little bit. He wanted to know if it could be because of the vaccine? He stated that sometimes he feels fine and other times he feels strange. He stated that sometime he just feels different. He said that he received the vaccine on 24Dec2020. Caller said that sometimes he is perfectly fine and then he will get the headache or nausea for a few moments and then it would go away. Caller said that at the doctor's office his blood pressure was 118/78 and his O2 sat was 99% He stated that he does work around Covid patients and takes all precautions when he is around them. He said that exactly 12 hours later after receiving the vaccine at 2200 24Dec2020, he said that it felt like someone shot him in the arm. 2-3 hours after he got up on 25Dec2020 it was gone. Caller said that he rarely gets sick and has not had the flu vaccine. The outcome of the events nausea, and headache was not recovered, and arm was sore was recovered on 25Dec2020, while unknown for the event feeling abnormal.
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| 46 | 2021-01-14 | tremor |
woke up in the middle of the night; shivering; shaking; feverish, general malaise; muscle aches and ...
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woke up in the middle of the night; shivering; shaking; feverish, general malaise; muscle aches and pains; headache. Lasted about 36 hours. Patient took ibuprofen; acetaminophen.
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| 46 | 2021-01-15 | feeling of insects crawling on skin |
Low grade headache/dizziness/cobwebs still 10 days after vaccine - always there but sometimes barely...
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Low grade headache/dizziness/cobwebs still 10 days after vaccine - always there but sometimes barely feel, sometimes stonger
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| 46 | 2021-01-20 | weakness |
fever; chills; fatigue; weakness; pain in the arm (injection site)/sore arm; joint pain; Headache; T...
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fever; chills; fatigue; weakness; pain in the arm (injection site)/sore arm; joint pain; Headache; This is a spontaneous report from a contactable other HCP. This 46-Year-old male Other HCP (patient) reported that he received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) at 1 DF single dose at right upper arm for covid-19 immunisation on 11Jan2021 around 10 AM. Relevant history included ongoing asthma, environmental and food allergies (ongoing). The patient was also allergic to a few medications, both had his entire life. Relevant concomitant drugs were unknown. The subject previously received the first dose BNT162B2 (Batch/lot number: EK4176, Lot number: EJ1685) at the right upper arm on 21Dec2020 for covid-19 immunisation. The patient was tested for COVID Virus before his vaccination either on 07Jan2021 or 08Jan2021. The patient experienced fever last night (11Jan2021), this symptom was gone but he described it as if fever went and came back but it seemed to be gone, he had also experiencing waking up with chills, fatigue, weakness, pain in the arm (injection site) and joint pain since the evening/night of 11Jan2021. He went and saw his primary care doctor. He had been using Tylenol and Antihistamines. He took Tylenol for joint pain. The patient stated it was not bad to start. Experienced fever, headache, fatigue, weakness, joint pain, waking up with chills, and a sore arm, which was to be expected. In general he was just really fatigued. Fever: Had come and gone. It was hopefully gone for good. He had a low grade fever last night, but he checked his temperature an hour ago and it was 98.6 Fahrenheit on 14Jan2021. The outcome of fever was recovered on 13Jan2021, the outcome of headache was recovering, the outcome of event pain in the arm (injection site)/sore arm was unknown. The outcome of other events was not recovered. on the 3rd day. He did a test for the virus and it came back negative. Information about lot/batch number has been requested.
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| 46 | 2021-01-20 | bell's palsy |
Pfizer-BioNTech COVID- 19 Vaccine EUA Received communication that patient experienced a Bell's Palsy...
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Pfizer-BioNTech COVID- 19 Vaccine EUA Received communication that patient experienced a Bell's Palsy symptoms on 1/16/2021. Patient received vaccine dose #1 on December 18, 2020 and dose #2 on January 8, 2021.
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| 46 | 2021-01-22 | facial paralysis, bell's palsy |
Left side of face started drooping on Thursday afternoon. Was diagnosed with Bells Palsy on Thursday...
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Left side of face started drooping on Thursday afternoon. Was diagnosed with Bells Palsy on Thursday evening.
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| 46 | 2021-01-23 | weakness |
The next morning after the vaccine I began feeling light-headed and weak. Over the next few hours s...
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The next morning after the vaccine I began feeling light-headed and weak. Over the next few hours symptoms worsened to include fever of 102.3, chills, body-aches and extreme fatigue. I was coughing more as well. Heart rate elevated to 110 bpm. These symptoms lasted about 12 hours. By the next morning, approx 24hrs after symptoms started, I was back to normal.
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| 46 | 2021-01-24 | migraine |
Sunday, Jan 24th 2:22 am - woke to violent, uncontrollable chills/shivers - lasted for 8 minutes bef...
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Sunday, Jan 24th 2:22 am - woke to violent, uncontrollable chills/shivers - lasted for 8 minutes before stopping. Severe migraine-level headache. 6:30 am - thoracic muscle pain/soreness, occasional chills continued, axillary temp 100.4 F. 17:35 pm - repeat episode of violent chills/shivering - lasted for 5 minutes, severe headache continued, axillary temp 101.8 F. Monday, Jan 25th 3:30 - woke with continued severe headache and mild chills. Axillary temp 100 F.
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| 46 | 2021-01-26 | burning sensation |
Began on the 21st of December, sores on the tip of the tongue and progressed to canker like sores on...
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Began on the 21st of December, sores on the tip of the tongue and progressed to canker like sores on the inside of the bottom and top lips , burning sensation that covered the facial area. Doctor instructed to keep taking Valtrex and prescribed a Z pack , I was already taking the Valtrex with little to worsening effect BUT after administering the Z pack condition quickly deminished and went completely away within 2 days.
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| 46 | 2021-01-27 | difficulty speaking |
subject developed hives/itchy bullae over trunk and extremities. over the next few days, despite usi...
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subject developed hives/itchy bullae over trunk and extremities. over the next few days, despite using diphenhydramine, also had swelling of lips and sensation that his throat was closing. Voice was slightly hoarse. Was seen in clinic and ER. was given steroids.
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| 46 | 2021-01-28 | tenderness |
Difficult to determine if this event was related to vaccination. 46 y.o. male with a pertinent inte...
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Difficult to determine if this event was related to vaccination. 46 y.o. male with a pertinent interval and past history of HTN, sponge kidney, ckd, gerd and HLD. Presents to ED with worsening redness and tenderness of his right upper mid thigh. Patient states that he got the Pfizer vaccination yesterday second shot evening and then developed some subjective fevers sweats and chills. Also had myalgias this all lasted approximately 2 hours but he was able to get to bed and fall asleep. Woke up this morning feeling better but still with some chills but noticed some tenderness and redness in his right upper mid thigh. This got progressively worse. Continues to have chills but improving. ED work-up including CBC unremarkable, CMP with mild hyponatremia and hypokalemia of 134 and 3.4 respectively. ED drew blood cultures and then started vancomycin. Vitals normal and stable in ED. Admitted to hospital. Provider notes on 2nd day of admission as follows. Cellulitis and abscess of the right medial thigh likely secondary to a skin tag tear which introduced infection. Patient currently is on broad-spectrum antibiotics in the form of doxycycline and vancomycin. Unfortunately, the patient has been eating just ate lunch and also has been getting Lovenox. He is not going to tolerate a bedside incision and drainage. We will plan on proceeding to the operating room tomorrow for quick I&D and cultures. Procedures been explained. The wound will need to be packed afterwards and ultimately healed in. Patient seems understand plan and we will proceed accordingly
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| 46 | 2021-02-01 | tremor, feeling cold |
Approximately 10 hours after receiving my second COVID shot and right before I went to bed at 10pm I...
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Approximately 10 hours after receiving my second COVID shot and right before I went to bed at 10pm I started getting chills. My symptoms worsened as the night went on, I was shaking and could not get warm. I also had a very bad headache and I had trouble lifting myself up. At about 3am I started sweating and feeling feverish. I got out of bed to take Tylenol and drink water, and had trouble walking and I was breathing heavy. At 6am I decided to take a hot bath with Epsom salts to help with my aches and headache. When I got out of the bath I felt very dizzy and fatigued and need assistance from my wife to get back in bed. At about 9am I started feeling better. I sat myself up and ate apples and salty tortilla chips and drank lots of water. By 1pm I was able to walk without difficulty and I felt better with only a mild headache.
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| 46 | 2021-02-03 | feeling cold, seizure |
I have never had a seizure in my life before or since, but that morning I had five partial focal sei...
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I have never had a seizure in my life before or since, but that morning I had five partial focal seizures in y right arm, over the course of six minutes. As I was on the phone (to report the first one to my caregiver) when the second hit, I inadvertently punched myself rapidly and repeatedly in the right side of my head, with the phone handset functioning as an impromptu bludgeon, leaving bruises reminiscent of the victim of a fist fight. Also at the time I had a strong headache, cold chills, a 102 degree Fahrenheit fever and body aches. None of which persisted beyond noon.
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| 46 | 2021-02-03 | cold extremities |
Fever, Chills, Fatigue, Body aches, cold hands / feet even with the heater blasting. Duration of eve...
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Fever, Chills, Fatigue, Body aches, cold hands / feet even with the heater blasting. Duration of events: ~2 days.
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| 46 | 2021-02-03 | tremor | Elevated BP 176/108 , shakiness, didn?t ?feel right?, several episodes of vomiting. |
| 46 | 2021-02-04 | tenderness |
Reported that he was under dosed. Noted injector did not give full dose. Reported had slight stiff n...
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Reported that he was under dosed. Noted injector did not give full dose. Reported had slight stiff neck over L side of neck x 1 minute within 15 minutes and subsided. Overnight had L side of neck tenderness and subsided the day after.
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| 46 | 2021-02-07 | weakness, feeling hot |
tightness on the chest; chest was hurting and felt like it has been compressed; congested; body ache...
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tightness on the chest; chest was hurting and felt like it has been compressed; congested; body aches/ his body is still aching/ body was aching/ achy; headaches; fever/ he has a temperature at 100; tired; felt weak; feeling kind of hot and achy; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number: EL9261, expiry date unknown) via an unspecified route of administration on 20Jan2021 at a single dose on the left arm for COVID-19 immunization. The patient had no medical history and no known allergies. There were no concomitant medications. The patient did not receive medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. The patient received the first dose of BNT162B2 (lot number: EL1284, expiry date unknown) on 29Dec2020, 11:00AM at a single dose on the left arm for COVID-19 immunization. The patient reported he is probably 160 pounds, 5ft 6 inches; he received the second dose of the COVID-19 vaccine on 20Jan2021, while being due for it on 19Jan2021. He explained having body aches, headaches, fever, tired, and felt weak the following morning (21Jan2021, 04:30 AM) and therefore went to the ER. He had blood works and an X-ray done on 21Jan2021 (results unknown) and they said he had no COVID. Today, 22Jan2021, he has a temperature at 100, his body is still aching, the headaches are there along with a tightness on the chest that concerns him. He also described it as his chest was hurting and felt like it has been compressed. Patient asked what to do. He then mentioned that the nearby urgent care had refused to take him because the vaccine is still 'under investigation' and the ER is far away. Patient also reported that he was feeling kind of hot and achy, body was aching on 21Jan2021.Today, 22Jan2021, he was still the same. He got a fever, was congested, and his body is aching. Patient did not received treatment for the events. Outcome of the events 'body aches/ his body is still aching/ body was aching/ achy,' headaches, 'fever/ he has a temperature at 100,' tired, felt weak, 'feeling kind of hot and achy,' and congested was not recovered. Outcome of the other events was unknown. The events body aches/ his body is still aching/ body was aching/ achy,' headaches, 'fever/ he has a temperature at 100,' tired, and felt weak required Emergency room visit and were reported as medically significant.
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| 46 | 2021-02-07 | numbness |
At 1700 01/10/2021, he began to feel numbness in his left lip, like he was given a numbing shot at t...
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At 1700 01/10/2021, he began to feel numbness in his left lip, like he was given a numbing shot at the dentist. Over the next hour, it traveled superiorly up to his left cheek and to the inferior ear. He had a steroid and antihistamine sent in to the pharmacy and took this once he got home about 1930. Shortly thereafter, he started developing tongue numbness. He woke up in the middle of the night to use the restroom and reports he nearly fell into the bathroom wall due to the intensity of vertigo he was experiencing. The vertigo worsened throughout the day and he is very unsteady on his feet, requiring assistance and support from his wife to ambulate. He is unable to drive and reports exacerbation of dizziness when moving his head side to side. His wife reports he had a fever throughout the night 01/10/2021-01/11/2021. He feels the left eye is dryer and a bit weaker than usual and he has had to administer drops to help keep it moist.
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| 46 | 2021-02-08 | feeling cold, tremor, pain in extremity |
The first dose of Pfizer vaccine was on 1/17/2021. I did not feel anything except a severe pain over...
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The first dose of Pfizer vaccine was on 1/17/2021. I did not feel anything except a severe pain over my left arm only. But the second dose of this vaccine (on 2/7/2021) was different. In addition to the severe pain on my left arm, I had (and still) a severe headache, pains all over my body and bones, high fever (102), dizziness, shaking, fatigue, cold at all times, and a little bit taste loss (as of right now, 24 hours after the vaccine). It looks like a hard flu symptoms exactly.
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| 46 | 2021-02-09 | numbness, discomfort |
Approx. 1-2 minutes after vaccine patient reported numb left arm and gradual numbing/heavy feeling o...
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Approx. 1-2 minutes after vaccine patient reported numb left arm and gradual numbing/heavy feeling of entire left side. ( face, leg, arm) I was made aware about 15 minutes post vaccine ( 1;30pm). NO SOB, itching, rash. BP 136/102. I I suggested getting medical attention. Nurse at facility continued to observe patient for total 30-40 minutes. Patient said feeling better. AT 2;15pm and 2;45 pm I checked on patient both times he was felling "better" than the last time I checked on him. Numbing was subsiding. Both times I urged him get medical attention. He did call his PCP> He would not go to ER, considered urgent care. ***patient told me before his 2nd dose that he had a numb arm post 1st dose, he did not report this to clinic staff day of 1st clinic** I plan to follow up with patient in 24 hours.
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| 46 | 2021-02-09 | numbness, pain in extremity | nausea coughing sneezing sore and numb arm |
| 46 | 2021-02-11 | tingling, numbness |
12/15 vaccination 1/1 4:30 started having tingling and numbness in face, L side. Felt 'off'. My le...
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12/15 vaccination 1/1 4:30 started having tingling and numbness in face, L side. Felt 'off'. My left arm started to tingle and numb. Didn't last very long. Would come and go. Laid down. Ate some dinner; queasy. 1/2 Still felt 'off' 1/3 Symptoms occurred again with the numbness; face down to arm. HR was high for resting; 130's. BP 200/100. ED - CTA head/neck EKG, blood panel Symptoms resolved in ED; vitals normal 1/7 Neurology. Normal exam. MRI of brain; normal. Referral to cardiologist. Echocardiogram; normal Heart Monitor - waiting on results COVID - negative *DR/MGR of vaccine clinic
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| 46 | 2021-02-12 | feeling cold, tremor |
At 10:30pm (received vaccine shot #2 at 8:18am), i stood up and immediately felt chilled to the bone...
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At 10:30pm (received vaccine shot #2 at 8:18am), i stood up and immediately felt chilled to the bones and started shaking/shivering uncontrollably for 5min. Took temp, no fever. No other issues
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| 46 | 2021-02-13 | cold extremities |
On December 17, 2020, my husband, received his first BioNTech BNT162b2 COVID-19 vaccination. On Thur...
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On December 17, 2020, my husband, received his first BioNTech BNT162b2 COVID-19 vaccination. On Thursday January 7, 2021, he received this second COVID-19 vaccination. The following three days after his second vaccination, he felt fine. The fourth day, on Sunday January 10, my husband felt extremely fatigued. On Monday the 11th and Tuesday the 12th, he worked a full shift but complained of extreme fatigue and extreme chills to the point that his teeth were chattering while on the phone with me. He decided to work through it. When he got home on Monday night, he started vomiting. On Wednesday January 13, he woke up and had swollen eyes. Once again, he felt extremely fatigued, even after a full nights rest. He had the day off but had an early meeting. After his meeting, he was still tired so he went back to sleep. I left to get lunch, and drop off our kids, and upon my return, I found him on the walk in closet floor, face up, having passed away. He felt as cold as ice. The rapid test done after they called the paramedics resulted in a negative COVID-19 test for him.
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| 46 | 2021-02-15 | night sweats, hot flush |
Lingering headache for 6 days. Hot flashes/night sweats and on-going chills. Tiny mouth sores. No...
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Lingering headache for 6 days. Hot flashes/night sweats and on-going chills. Tiny mouth sores. No appetite. No libido. All symptoms have lasted for 6 days.
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| 46 | 2021-02-15 | pain in extremity | Chest pain, shortness of breath, LEFT arm pain |
| 46 | 2021-02-15 | sciatica |
Got First Pfizer Covid vaccine on 06JAN2021. About 4 days after that I started noticing allergy symp...
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Got First Pfizer Covid vaccine on 06JAN2021. About 4 days after that I started noticing allergy symptoms and mild intermittent wheezing. Then on about the 5th day after, my lower back pain increased, causing significant sciatic pain worse than ever before. On 22JAN21 I ended up going to urgent care for increased breathing problems, and also had to have pain management appointment within days as sciatic pain was debilitating and also significantly interfered with my sleep. After steroid injection (In spine)on FEB 3rd for sciatica/back pain, and steroids/inhaler treatment for the breathing stuff, I would say I was pretty good to go . I didn't think too much of these unusual events for me both in timing and severity. On 12FEB2021, I got my second pfizer covid dose. I 14FEB I started noticing allergy symptoms again, and slight shortness of breath, used inhaler I had from before to help as breathing in seemed to not give me full breaths. Then, on 15FEB2021, in the evening out of nowhere while walking, my lower back/sciatica pain came back in full force, as if my leg were a lighting rod like before. So it almost seems as if the covid vaccine triggered an inflammatory reaction in my body. I am not certain, but because the series of events seem the same and in timing after my first covid vaccine, I figured I would at least report it.
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| 46 | 2021-02-16 | pain in extremity | LEFT ARM PAIN, OVER ALL MUSCLE WEAKNESS AND PAIN, & FATIGUE. |
| 46 | 2021-02-17 | numbness |
1/10/2021-Approximatley 34 hours after vaccination developed left facial numbness followed by severe...
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1/10/2021-Approximatley 34 hours after vaccination developed left facial numbness followed by severe dysequilibrium 5 hours later. 1/11/2021-left facial numbness and dysequilbrium significantly worse along with severe rotary nystagmus in the left eye. Had appointment with primary care and then ENT , who started me on prednisone 30 mg and antivert. ENT refered me to Neurology. Neurology ordered MRI/MRA that night and increased my prednisone to 60mg/day for 5 days followed by a taper over next five days. Currently, Symptoms of dysequilibrium and numbness have not subsided, on a second course of prednisone 60 mg/day for 3 days followed by taper. MD , Neurologist, provided Diagnosis of vaccine induced polyneuropathy affecting cranial nerves 5 and 8. Since the onset on January 10, Cannot work(physician/anesthesiologist) , drive, or perform minor tasks due to the severity of the symptoms. Symptoms during 1/10/21-1/17-21, bed-ridden, slept 18-20 hours/day, could not walk without assistance-would fall to the left, could not read, nystagmus of left eye, had to keep eyes closed due to severe vertigo/dysequilibrium, nausea. 1/18/21-1/24/21 slight improvement in disequilibrium/able to walk, no change in facial numbness severity , started on 100 mg gabapentin at night, and low dose valium 1.25 mg to 2.5 mg to help with dysequilibrium 1/25/21-1/29/21 50% improvement in facial numbness, began vestibular PT, slow improvement in dysequilibrium and ability to walk and read 1/30/21 Symptoms worsened again, facial numbness returned, dysequilibrium returned to its original severity, difficulty reading/focusing 2/1/21 Followed up with Dr, started another prednisone 60mg/day for 3 days, followed by taper over the next 5 days 2/4/21 Left Facial numbness not improved, dysequilibrium still severe, having difficulty focusing and reading
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| 46 | 2021-02-23 | discomfort, pain in extremity |
"I had an uncomfortable night and bad dreams, left arm soreness more painful than flu soreness. 1/4...
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"I had an uncomfortable night and bad dreams, left arm soreness more painful than flu soreness. 1/4/21 5am fever 100.5, and took Tylenol at 5am." Reported feeling better now at 10:30 am
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| 46 | 2021-02-23 | discomfort |
1. Minor headache 2. Moderate pain in left underarm. Minor swelling of lymph node in the same area. ...
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1. Minor headache 2. Moderate pain in left underarm. Minor swelling of lymph node in the same area. I feel discomfort when trying to place my arm against my body. I have to keep arm extended to avoid discomfort.
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| 46 | 2021-02-25 | facial pain |
started with slight pain in left cheek and then had swelling with no pain. started approximately 3 h...
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started with slight pain in left cheek and then had swelling with no pain. started approximately 3 hours after injection.
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| 46 | 2021-02-27 | feeling cold |
Pale, SOB, cold/chills, nausea, emesis, feels like I am drunk the patient stated. EMS evaluated. Ref...
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Pale, SOB, cold/chills, nausea, emesis, feels like I am drunk the patient stated. EMS evaluated. Refused transport.
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| 46 | 2021-02-28 | bell's palsy, facial paralysis |
On 2/22/2021, started to feel numbing sensation in mouth. On 2/26/2021, left side of face started to...
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On 2/22/2021, started to feel numbing sensation in mouth. On 2/26/2021, left side of face started to become paralyzed. On 2/28/2021, left side of face became totally paralyzed and went to ER because worried it was a sign of a stroke.
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| 46 | 2021-02-28 | tenderness |
I woke up on 1/9/2021 with my lower left leg swollen and red and DR said it could be a superficial b...
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I woke up on 1/9/2021 with my lower left leg swollen and red and DR said it could be a superficial blood clot. January 9 - ER - Diagnosed cellulitis - round of Ceflex for a week - things got worse. Since January 9, I've had two other separate ER visits and three rounds of CEFLEX. Was referred to Dermatology - Arrhythmia Nodusem - so now I'm off Ceflex and on a steroid regimen now. I just started it today. It hurts to even touch my skin and it hurts to walk.I'm in a lot of pain. I have no open wounds so no reason for this to happen.
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| 46 | 2021-03-02 | tingling |
Rash on neck, tingling, throat swelling. BP 148/86 (pulse 75), O2 sat 96%. Benadryl 50 mg IM x 1. Re...
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Rash on neck, tingling, throat swelling. BP 148/86 (pulse 75), O2 sat 96%. Benadryl 50 mg IM x 1. Resolved. BP 137/83 (pulse 80).
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| 46 | 2021-03-03 | numbness | lightheaded, numbness in fingers. Evaluated by EMS-Cleared |
| 46 | 2021-03-04 | feeling hot, tingling |
11:42am Patient complaint of feeling "tingling and warm" throughout body. RN present and took patie...
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11:42am Patient complaint of feeling "tingling and warm" throughout body. RN present and took patient to treatment area. Vital signs BP 142/91, HR 68, RR 18, O2 sat 98% on room air. Patient reports NKA, no past medical history, and takes vitamins at home. Patient observed and noted to be diaphoretic. Post vital signs patient states feeling better. Vital signs recheck BP 138/84, HR 66, RR 18, O2 sat 97% on room air. Education on sign/symptoms to monitor and adverse reactions provided by RN. Patient escorted to car accompanied by patients wife and RN at 12:10pm.
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| 46 | 2021-03-04 | grand mal seizure |
Approximately 3 minutes post-vaccination, the patient suffered a witnessed tonic-clonic seizure, whi...
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Approximately 3 minutes post-vaccination, the patient suffered a witnessed tonic-clonic seizure, which lasted less than a minute.
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| 46 | 2021-03-05 | flushing |
Immediate metallic taste, flushing, sweating, itchiness. Patient progressed to itching in throat an...
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Immediate metallic taste, flushing, sweating, itchiness. Patient progressed to itching in throat and mouth, mild SOB, tachycardia, nausea, and rash over chest, abdomen, upper arms, and back over the next 30-60 minutes. Treatment: Benadryl 50 mg PO, Zofran 4 mg PO, Loratidine 10 mg PO, ranitidine 150 mg PO. Repeat doses of Benadryl, Zofran, and Loratidine given later that day. Patient stated improved symptoms within a few hours. The facial redness and rash on chest persisted until the next morning.
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| 46 | 2021-03-10 | sciatica |
Felt mild sciatica pain Thu morning following 1st vaccine shot that Monday. Through the day (I was j...
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Felt mild sciatica pain Thu morning following 1st vaccine shot that Monday. Through the day (I was just working at home like every other day) Sciatica began to get worse deteriorating to probably the worst pain I've ever experienced. As I mentioned, my Sciatica has been well controlled for 10+ years. I would have occasional mild sciatica pain following hard falls wakeboarding or snowboarding, but haven't done either in weeks nor had any hard falls.
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| 46 | 2021-03-12 | pain in extremity |
Starting about 5-6 hours after the shot I developed severe bloating, cramping and gassy-ness, litera...
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Starting about 5-6 hours after the shot I developed severe bloating, cramping and gassy-ness, literally constant burping. My stomach has been in constant pain. I?ve also had a slight fever and a very sore arm. Tylenol and rest has worked for the fever and arm, and I've had some addition body aches. Not sure how much is due to being in bed for an extended period. Also on Friday (about 24 hrs after getting the shot I was pretty fatigued. I just woke up from 13 hours of sleeping. But the stomach cramps/pains was severe and prompted me to try to find a way to report it, especially since it doesn't seem to be too common. It's been really bad.
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| 46 | 2021-03-16 | muscle spasms |
Headache within an hour of the shot, left work. Muscle spasms in my upper back and neck within 4 hou...
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Headache within an hour of the shot, left work. Muscle spasms in my upper back and neck within 4 hours. Major spasm that prevented me from turning my head or laying down at around 6-8 hours. Upper back, neck, and muscle pain in my head and jaw continue today (3/17/21) but symptoms are slowly decreasing in severity.
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| 46 | 2021-03-17 | feeling hot |
pt had adverse rxn after his covid vac. he told me he felt hot, and his heart was racing. had him pu...
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pt had adverse rxn after his covid vac. he told me he felt hot, and his heart was racing. had him put his feet up, and take off his coat. we took bp @1pm=156/98, 1:08=150/96, 1:16 158/109, 1:30 139/92, 142Pm 134/91. We gave him benadryl 15 mls at 1:05pm.I gave him 3 benadryl 25mg for tonight if needed same with 3 ibuprofen 400 mg tablets. I called him at 2:20 pm to see if he got home okay. he did and was feeling better. he takes diabetic medication but doesn't know the names of the medications. he had eaten breakfast before his vaccine. dx syncope.
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| 46 | 2021-03-18 | numbness, tingling |
Numb/ tingling tongue, lips, fingers, & toes. Lasted 3, 4, & 5 March- subsided. Reoccured 16 Mar- on...
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Numb/ tingling tongue, lips, fingers, & toes. Lasted 3, 4, & 5 March- subsided. Reoccured 16 Mar- ongoing.
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| 46 | 2021-03-18 | pain in extremity |
Had fatigue and myalgias and low-grade fever, so stayed in bed most of the next day. Developed calf ...
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Had fatigue and myalgias and low-grade fever, so stayed in bed most of the next day. Developed calf pain 2 daysafter that. Was diagnosed with DVT via Doppler ultrasound on Monday, March 8, 2021.
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| 46 | 2021-03-19 | unresponsive to stimuli, seizure like phenomena |
After receiving first dose of pfizer covid vaccine, patient alerted EMS he didn't fell well. When EM...
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After receiving first dose of pfizer covid vaccine, patient alerted EMS he didn't fell well. When EMS responded to the patient the patient went unresponsive slumped over in his chair with seizure like activity. Patient was being moved when he regained consciousness. Patient was moved to EMS area. Patient was pale, lightheaded and nauseous. Blood pressure was taken as well as oxygen and heart rate. Blood sugar was checked and an IV was started. Patient was stable and transported.
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| 46 | 2021-03-20 | tremor |
Chills and Shakes started at time indicated, 2 hours later vomiting. Vomiting only lasted 20 minut...
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Chills and Shakes started at time indicated, 2 hours later vomiting. Vomiting only lasted 20 minutes. Second night, extreme sweating. Sunday still have some sweating and nausea but feel 90% better than Friday night.
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| 46 | 2021-03-22 | flushing | Chills, BP drop, and flush after Covid-19 vaccine |
| 46 | 2021-03-22 | pain in extremity |
Within hours of second dose(3/10/2021) in the right arm on 3/11/2021 I started feeling pain on the ...
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Within hours of second dose(3/10/2021) in the right arm on 3/11/2021 I started feeling pain on the underside of my left arm. As the days have gone on it?s gotten a little worse. Left under arm pain, armpit area, left chest (pectoral) pain. Just lingering pain. Very sensitive to the touch. I also developed a rash on the left side of my spine between the shoulder blades. It showed up this past weekend or the end of last week. It?s more of a painful rash than itchy. It?s very uncomfortable to lean against or lay on. This is all 13 days after the second shot. I have just been taking ibuprofen for the pain. Going to see my doctor today.
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| 46 | 2021-03-22 | pain in extremity |
Lost consciousness; fell face first onto floor; Arm pain; Chills shivering; This is a spontaneous re...
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Lost consciousness; fell face first onto floor; Arm pain; Chills shivering; This is a spontaneous report from a contactable other health professional (patient). A 46-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN6202), via an unspecified route of administration, administered in right arm on 05Mar2021 08:45 as single dose for COVID-19 immunization at a hospital. The patient has no medical history. Concomitant medications were not reported. Patient has no known allergies. The patient previously received the first dose of bnt162b2 (lot number: EL9264) on 12Feb2021 14:30 (2:30 pm) for COVID-19 immunization. The patient did not received other vaccines in four weeks. No COVID-19 test post vaccination was done. On 06Mar2021 at 13:45 (1:45 pm), the patient lost consciousness and fell face first onto floor. The patient also experienced arm pain and chills shivering. No treatment was received. The event required doctor's office visit. The outcome of the events was recovering.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 46 | 2021-03-23 | bell's palsy | Bell's palsy predniSONE 20MG vaiACYclovir HCL 1GM Artifitial Tears Erythomycin |
| 46 | 2021-03-23 | numbness, facial paralysis, weakness, tingling |
facial paralysis; dizziness; weakness; palpitations; tingling; extremities numbness; panic; anxiety;...
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facial paralysis; dizziness; weakness; palpitations; tingling; extremities numbness; panic; anxiety; chills; This is a spontaneous report from a contactable consumer(patient) reported for himself. A 46-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 06Mar2021 12:00 at single dose for covid-19 immunisation. Medical history included left kidney missing. Patient had allergies to Ambroxol, levofloxacino, cefalosporina, hidrocortizona. The patient's concomitant medications were not reported. First symptom took place 5 minutes after receiving the vaccine, it started with a severe dizziness followed by body weakness, quite accelerated and uncontrolled palpitations, tingling and extremities numbness, mild right-sided facial paralysis, panic feeling and anxiety. Finally, severe chills. Full recovery after 40 minutes with a mild lightheadedness for a few hours. Vital signs kept stable at all times according to paramedics' diagnosis. Patient received treatment for these events. Outcome of events was recovered. Information on the lot/batch number has been requested.
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| 46 | 2021-03-23 | pain in extremity |
Sudden and significant lower back pain in lubar region and localized without radiation to the legs. ...
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Sudden and significant lower back pain in lubar region and localized without radiation to the legs. Pain persisted 7/10 for first 12 hours from onset, gradually lowering to level of 2/10 over 48 hours and then 1/10 after 72 hours. Onset of pain occurred without physical stress to the region (was quietly sitting in a chair). Pain similar to when I herniated L5-S1 years ago (requiring hospital transport). Pain was controlled to tolerable levels by immobilization (lie on floor with knees elevated, application of heat, and ibuprofen. I did not associate this with the vaccine initially, but after consulting with my doctor, he recommended I report, as he stated there were some earlier reports about back pain with the similar Moderna vaccine, and there isn't a physical explanation otherwise as to why the sudden pain.
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| 46 | 2021-03-24 | one side paralysis |
left pontine stroke patient had right sided weakness of upper and lower extremity 3 days after vacc...
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left pontine stroke patient had right sided weakness of upper and lower extremity 3 days after vaccination and presented to the emergency department on day 6 when he was found to have a stroke on MRI
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| 46 | 2021-03-25 | numbness | After a couple hours my face and head went numb. |
| 46 | 2021-03-28 | pain in extremity |
Left arm lymph nodes are swollen and painful. My entire arm hurts down to my fingers. Diarrhea, body...
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Left arm lymph nodes are swollen and painful. My entire arm hurts down to my fingers. Diarrhea, body pain and fatigue.
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| 46 | 2021-03-30 | electric shock sensation |
On or about 0845 am, RN administered Covid vaccine (2nd one for patient). Attempted administration w...
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On or about 0845 am, RN administered Covid vaccine (2nd one for patient). Attempted administration with syringe (a Haiou, 1ml, 23g, 1'', Lot 20JC2, Exp: 10-17-25) resulted in needle going into patient's arm, but the 2 piece retractable distal needle and hub separated from the proximal tube part of the syringe resulting in COVID vaccine dose being lost. None of the 1st dose entered patient's arm. With needle and distal hub still fully immersed in patient's arm, RN removed it and held pressure on bleeding. RN informed patient that needle failed, to which pt stated he was "shocked," and felt an "electric" sensation when needle was inserted. Patient tolerated well. Bleeding abated. RN administered a 2nd dose of vaccine to the patient with no problems on the same LUE, more medial by about 2 inches than the first attempt. Bandage applied to both sites due to scant bleeding. Patient tolerated well, but showed no emotion. Pt complied with all instructions, and RN thanked patient for coming in.
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| 46 | 2021-03-30 | pain in extremity |
Here are my side effects: 1. Low grade Fever 2. Arm so sore that you dont want to move it 3. Body A...
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Here are my side effects: 1. Low grade Fever 2. Arm so sore that you dont want to move it 3. Body Aches 4. Fatigue 5. Headache 6. Metallic Taste in my mouth. Nothing tasted good yesterday. 7. Nasal Drip with Nausea
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| 46 | 2021-03-31 | facial pain | Pain in the 2 sides of the face (under ears) close to the temporal bone |
| 46 | 2021-04-02 | flushing |
Patient developed flushing and rash on his neck. Improved with benadryl. Was monitored for several h...
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Patient developed flushing and rash on his neck. Improved with benadryl. Was monitored for several hours, remained stable, discharged home.
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| 46 | 2021-04-02 | tremor, weakness |
Body has been weak and shaky since I got the vaccine. I have had 2 episodes where I am short of brea...
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Body has been weak and shaky since I got the vaccine. I have had 2 episodes where I am short of breath and my blood pressure has gone up. The doctor has put me on anxiety medication but I still feel no difference. I have not been able to work for the past 3 weeks.
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| 46 | 2021-04-03 | migraine | Appointment with family doctor next week |
| 46 | 2021-04-06 | muscle spasms, pain in extremity |
Sore arm; Muscle cramps all over the body; Sugar was very high; Dehydrated; This is a spontaneous re...
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Sore arm; Muscle cramps all over the body; Sugar was very high; Dehydrated; This is a spontaneous report from a contactable consumer (patient's mother). A 46-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on 27Feb2021, at a single dose, for COVID-19 immunization. The patient's medical history included heart attack (at the age of 39) and had couple of stents (and the things done) later after that, and Lyme disease (past this Summer). The patient was taking several concomitant medications (unspecified). The patient's mother was calling for her son (patient) as he works out on the road, but he has had a heart attack at 39 years old and has had some other problems. The patient got his first Pfizer shot and about 2 to 3 days later while he was working, he first just had the sore arm on 03Mar2021. The patient worked in fiber glass repair on pools and it was very warm, and he started having muscle cramps all over the body on 03Mar2021. The patient ended up in the hospital on 03Mar2021 and his sugar was very high, and he was dehydrated. As treatment taken for the events, they gave him fluids through an IV and they gave him metformin medication 500 mg. The patient underwent laboratory tests and procedures (his doctor did the laboratory work), and they did laboratory work at the hospital where he went. It was clarified that they just did blood work on 03Mar2021, but the patient's mother didn't know what it was. The patient was just held for observation and was out the next day (04Mar2021). That was only the first shot, so the patient was really afraid to get the second shot one. The patient's mother told him she will try to find out something about it. patient's mother looked up the side effects and she did not see that as a side effect. At the time of reporting, the patient still had cramps once in a while. The patient had not recovered from "Muscle cramps all over the body". The outcome of the other events was unknown. Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
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| 46 | 2021-04-06 | pain in extremity |
Patient received COVID immunization #1 on 3/17/2021, then on 4/1/2021 he started having right calf p...
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Patient received COVID immunization #1 on 3/17/2021, then on 4/1/2021 he started having right calf pain and swelling. Got worse over the following 3 days so he presented to Urgent care. DVT was identified in UC on bedside ultrasound, started on Eliquis that day.
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| 46 | 2021-04-07 | flushing, unresponsive to stimuli |
Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hyperventil...
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Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hyperventilation-Medium, Systemic: Hypotension-Medium
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| 46 | 2021-04-07 | flushing, unresponsive to stimuli |
Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension...
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Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium
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| 46 | 2021-04-07 | numbness |
Patient reported numbness of the right side of face and right arm weakness 2 hours after receiving v...
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Patient reported numbness of the right side of face and right arm weakness 2 hours after receiving vaccine. Patient didn't take any medication for this occurrence. Symptoms went away after 45 minutes and then returned again on 4/8/2021. Pharmacist on duty recommended patient see a doctor on 4/8/2021
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| 46 | 2021-04-07 | numbness |
numbness in arm and shoulder, radiates down to fingers. pain in whole arm, not just localized to inj...
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numbness in arm and shoulder, radiates down to fingers. pain in whole arm, not just localized to injection site. injection site is worse though. have tried ice and tylonol
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| 46 | 2021-04-07 | pain in extremity |
arm pain; malaise; This is a spontaneous report from a contactable consumer. A 46-year-old male pati...
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arm pain; malaise; This is a spontaneous report from a contactable consumer. A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates were not provided) via an unspecified route of administration, on 11Feb2021, as single dose for COVID-19 immunisation, at Workplace clinic. Patient's medical history and concomitant medications were not reported. Patient did not receive other vaccine in four weeks of vaccination. Patient did not receive Other medications in two weeks of vaccination. On 12Feb2021, the patient experienced arm pain and malaise. No treatment was received for the events. Patient was not diagnosed with COVID prior vaccination. Patient has not been tested for COVID post vaccination. Outcome of the events was reported as not recovered. Information on Lot/Batch number has been requested.
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| 46 | 2021-04-08 | flushing, unresponsive to stimuli |
Site: Pain at Injection Site-Medium, Systemic: Cardiac Disorder (diagnosed by MD)-Severe, Systemic: ...
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Site: Pain at Injection Site-Medium, Systemic: Cardiac Disorder (diagnosed by MD)-Severe, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Tachycardia-Medium, Additional Details: PT HAD FLUSHING AT 9 PM HEADACHE AND PASSED OUT FRACTURING HIS MANDIBLE IN PROCESS. PT HAD ATRIAL FIBRILLATION PT IS IN STABLE CONDITION ON DILTIAZEM HAD NO HX OF HEART DISORDERS PRIOR TO VACCINE
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| 46 | 2021-04-08 | flushing | Flushed and Tachycardic |
| 46 | 2021-04-08 | tingling |
patient admits to vagal response and passing out in past. few mins after vaccine became diaphoretic ...
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patient admits to vagal response and passing out in past. few mins after vaccine became diaphoretic and near syncopal. arrived to obs and placed in tredelenberg, bp 119/80 hr 58 rr 18 sats 98% on ra. offered snack and water, refused snack. few mins later, diaphoresis resolved. stretcher sat up, bp 123/78 hr 50 rr 18 sats 98% on ra; states baseline is bradycardic around 50's. sat up to side of bed with feet dangling, bp 116/81 hr 52, then 112/80 hr 58, then standing bp 104/70 hr 63, patient started to feel dizzy and needed to lie back down, once laying down bp returned to 123/81 hr 50. 5 mins later, sitting bp 118/81 hr 53, standing 111/75 hr 58, few mins of standing had bp 90/63 hr 57, tingling in fingers and dizziness, causing patient to need to lay back down. few mins later lying bp 109/69 hr 59 sitting bp 113/70, 114/79, 121/86. standing bp checks 121/87, 114/82, and stabilized with final bp at 117/83. no further s/s of issues or orthostatic hotn. escorted with spouse, who was driving, to exit with no issues.
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| 46 | 2021-04-10 | feeling cold, seizure |
After sitting in waiting room at 10:00, at 10:03 a.m. began to feel strange with a sort of coldness ...
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After sitting in waiting room at 10:00, at 10:03 a.m. began to feel strange with a sort of coldness and dizziness. Woke up on the floor with nurses around. Was told by nurses, I was convulsing and was placed on the floor by nurse. After several minutes paramedics arrived and checked all vitals and blood pressure.
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| 46 | 2021-04-11 | weakness, pain in extremity |
The day of the vaccine patient started feeling tired, and weak with arm pain . As the days went by ...
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The day of the vaccine patient started feeling tired, and weak with arm pain . As the days went by the patient started deteriorating and was feeling more tired and and weak and abdominal pain 4 days later patient decided to go to urgent care (March 4,2021) Patient was declined because he had Covid symptoms such as chills and fever. Patient instead got Covid tested, results came back negative. Abdominal pain that patient had was getting worse and fever and chills had not improved. On Monday March 8,2021 patient was admitted into hospital and underwent 2 surgeries. He also had 6-8 inches of his colon cut and was left with and Ostomy bag and will be needing a 3rd surgery in June. patient was released from the hospital Wednesday 24th, 2021
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| 46 | 2021-04-11 | pain in extremity | Sore Arm and sore neck muscles starting at 1 o?clock am |
| 46 | 2021-04-11 | tenderness |
11:55 p.m. day of vaccine woke up with severe chills, muscle aches heavy breathing. Under my left ar...
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11:55 p.m. day of vaccine woke up with severe chills, muscle aches heavy breathing. Under my left arm there is swelling and tender to the touch at that location. 22 hours after vaccination chills subsided, however fatigue, achiness, headaches, chills and swelling under left arm still remain. 38 hours after vaccination headache still persists, chills still come and go, swelling under left arm visible along with headaches
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| 46 | 2021-04-12 | flushing, feeling hot |
Patient began experiencing feeling hot and flushed approximately 10 minutes after injection. He fel...
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Patient began experiencing feeling hot and flushed approximately 10 minutes after injection. He felt it was similar to his anxiety attacks he had in past. He had multiple "waves" where he said he would feel anxious, his heart rate would increase. His vital signs remained stable. At 09:26 am, he had a tightness in chest and states he normally gets that with his anxiety. Site captain consulted and continued to monitor patient and vitals. At )9; 33 a.m. he had chest pressure, and tightness. Described the pressure was 'different' than his usual. EMS was called and recommended follow up at hospital since his father died of heart attack at age 38, and he has had no follow up with heart since he was in high school. Patient refused EMS transport but his wife said she would drive him to be evaluated. EMS loaded patient into private vehicle.
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| 46 | 2021-04-13 | weakness |
Symptoms: lethargic, exhausted, tired, sleepy, low energy, short of breath while talking, short of b...
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Symptoms: lethargic, exhausted, tired, sleepy, low energy, short of breath while talking, short of breath even with minimal physical activity , it's been 7 days since vaccine, unable to finish 8 hr shift at work
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| 46 | 2021-04-14 | pain in extremity | Fever, aches, general malaise |
| 46 | 2021-04-14 | tingling |
Site: Pain at Injection Site-Severe, Systemic: Joint Pain-Severe, Error: Shoulder Joint Injury (prol...
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Site: Pain at Injection Site-Severe, Systemic: Joint Pain-Severe, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.), Additional Details: Patient called to let the pharmacy knows that he has been feeling a lot of pain especially at the shoulder area since his shot on 4/5. He has been taking ibuprofen 800mg and it did not help with thre pain. He has a hard time putting his arm against the balcony at home. He reported that his symptoms are not getting better. I advise the patient to seek medical help from his primary doctor to assess his shoulder pain.
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| 46 | 2021-04-14 | unresponsive to stimuli, weakness |
Systemic: Body Aches Generalized-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhau...
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Systemic: Body Aches Generalized-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: difficulty walking had to call 911-Severe, Systemic: Nausea-Severe, Systemic: Weakness-Severe, Additional Details: per Nurse, pt developed severe vertigo and pt had developed weakness and lead to difficulty walking
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| 46 | 2021-04-15 | feeling hot |
hot, sweaty, room swirling. 1610 pulse 49, p ox 96%. No issues breathing. He was grey, felt faint, r...
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hot, sweaty, room swirling. 1610 pulse 49, p ox 96%. No issues breathing. He was grey, felt faint, room swirling; stated felt like would pass out. Leaning back in chair. Rapid response called; BP 98/60. 1615 Treatment/intervention : given epi 0.3 mg in R thigh. BP 100/70; feeling better; pulse up to 64, p ox 96%. Still grey, sweating. Able to drink water. 1630 Pulse 68; p ox 93-94%, with mask off 96%. Patient reports past history of reaction to flu vaccine; no allergies noted. Agreeable to be monitored in ED; got in wheelchair without dizziness; still grey.
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| 46 | 2021-04-15 | tingling |
Facial/mouth tingling of left mandibular area that started approximately 10 minutes after injection....
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Facial/mouth tingling of left mandibular area that started approximately 10 minutes after injection. Client given Benadryl 50mg po x1 approximately 5 minutes after symptoms began. Client reported increased in facial/mouth tingling and complained of nausea. No vomiting. Client continued to report increasing symptoms of facial/mouth tingling which resulted in transport to the local ER. No notable external edema observed in facial area or otherwise.
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| 46 | 2021-04-16 | muscle spasms, numbness, tingling |
A 46 y.o. male who presents today with numbness in both legs, difficulty concentrating and forgetful...
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A 46 y.o. male who presents today with numbness in both legs, difficulty concentrating and forgetfulness, and cough with chest tightness. Covid symptomatic in November. Received Covid Pfizer vaccine on 4.13.21 at 1pm. Felt fine headed into the vaccine. He completed the observation period and felt chest tightness after about 5 minutes similar to Covid in November. He felt slightly better and went to work. At work his cough and chest tightness worsened. Very tired, unable to eat with no appetite. Extreme fatigue Wednesday sleeping most of the day. Cough and chest tightness and feeling he cannot catch breath like being submerged in a pool. On 4.15.21 his feet became numb and tingling bilaterally. He felt more confusion, forgetting what he was doing, left frozen food in the sink and unable to recall why. He is also having headache posteriorly 7-8/10 which began on 4.14.21. He reports headache is not common, now 3-4/10 and feels very similar to Covid in November. Does have some mild neck stiffness associated. Chest tightness almost identical to Covid in November. Reports numbness and tingling in the feet has been ascending in nature. He felt unsteady on his feet yesterday morning. He is having tingling and cramping in the bilateral calf muscles today. His cough continues with no phlegm. Comes in coughing spells with chest tightness. He also noted cough is worse with exertion. Fever 99.8 yesterday. No diarrhea. No loss of smell or taste. In ED noted to have right LE weakness. Wife reports that he seemed unsteady while walking Kept for observation. difficulty concentrating - back to baseline 4/17/21 at 3:26 pm assessment SOB: CTA thorax 4/16/21 unremarkable CT angiogram thorax Symptoms began approximately 5 minutes after his Pfizer. Reports that his cough and shortness of breath now seems to be improving. Continues to have some mild chest tightness, intermittent cough. Robitussin significantly helped. Extensive workup including CT angiogram of the thorax reveals no evidence for pulmonary embolism or infiltrate. COVID-19 PCR testing is negative x2, severe respiratory isolation has been discontinued. Patient has a negative D-dimer, LDH, ferritin, CRP. Cardiac troponin has been negative x2. Patient does have some wheeze, after cough, suggesting some bronchospasm. Will trial albuterol inhaler q.i.d.. Patient does report a history of what sounds like an environmental triggers asthma like event in the past, though reports that he has undergone evaluation for asthma and was told that he does not carry a diagnosis of asthma. Patient is currently on room air. I have reviewed the reported adverse reactions from the Pfizer vaccine and coughing shortness of breath are not listed. Continue supportive care, with Tessalon and Robitussin, IS
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| 46 | 2021-04-16 | pain in extremity, tingling |
Pfizer shot administered on 03/30 at vaccination center. Day 1 sore left Arm, Day 2 sore left Arm. D...
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Pfizer shot administered on 03/30 at vaccination center. Day 1 sore left Arm, Day 2 sore left Arm. Day 2 on 04/13 weeks after 1st shot headaches, joint and muscle pain. Sore throat and Covid Rapid Antigen Abbot Testing ministered on 04/16 . Results negative. Constantly joint tingling and some leg muscles felling sores.
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| 46 | 2021-04-16 | pain in extremity |
Woke up on the second day with pain In right shoulder and right wrist and right hand areas. I origi...
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Woke up on the second day with pain In right shoulder and right wrist and right hand areas. I originally thought I slept on the shoulder wrong. The pain in the right wrist lasted for about 5 days. It has lessened through today but can still be achy. Shoulder pain persists. It is acute pain if I raise the shoulder while keeping elbow and hand parallel to the ground above shoulder height. I read today these symptoms could result from vaccination and the timing fits.
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| 46 | 2021-04-16 | tingling, burning sensation |
On 4/14/21 in afternoon I started to feel tingling in my feet and hands. The tingling in my feet pro...
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On 4/14/21 in afternoon I started to feel tingling in my feet and hands. The tingling in my feet progressed to intermittent burning and pain. Pain kept me awake Thursday and Friday nights. It appears to have started in just the tips of my toes and now I am having sensation up to my calves. I went to ER on Saturday morning where lumbar CT ruled out nerve impingement and lab tests for Lyme disease are still pending.
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| 46 | 2021-04-18 | weakness |
On March 25, 8 days after the vaccine shot in my left arm, I began experiencing intense pain on the ...
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On March 25, 8 days after the vaccine shot in my left arm, I began experiencing intense pain on the left side of my neck and head. By March 28 the pain had become so excruciating I went to an Urgent Care facility and they sent me to the Emergency Room. While in the ER I had blood tests and a CT scan which all came back negative. I was given Oxycodone-Acetaminophen for the pain and prescribed Cephalexin in case there was some type of infection. They also ruled out Shingles. I continued to have pain and contacted my Primary Care Physicians Office and spoke with one of the Physician Assistants two times the next week. She prescribed Baclofen 10 mg and took me off the Cephalexin and put me on Amoxycillin because we thought the problem might have been an ear infection. The next week I spoke with my Primary Care Physician, and he believed I was suffering from Trigeminal Neuralgia, so he put me on Carbamazepine 200 mg twice a day. That same week, on April 9, I was finally able to meet with the Physician Assistant at the Neurologists office and she also believed I was suffering from Trigeminal Neuralgia. I continued to take the Carbamazepine daily and the Baclofen and Oxycodone-Acetaminophen as needed. On Monday April 12 I informed the nurses at the Neurologist office that I was experiencing several symptoms/side effects that included dizziness, weakness, difficulty swallowing and a pounding heartbeat. The nurses talked with the PA and the PA took me off the Carbamazepine and put me on Oxcarbazepine 150 mg twice a day and she prescribed Methylprednisolone 4 mg. On Thursday April 15 I began to have intense prolonged pain behind my left ear down to the neck and in the Trigeminal nerves in the forehead and top of the head on the left side. I was in so much pain I slept for less than 2 hours. The next morning, I vomited and went to the Emergency Room again. At the ER they treated my pain with a headache IV cocktail that included Ibuprofen, Benadryl, an anti-nausea medication, Fentanyl, and a steroid. Within an hour my pain level dropped from a 9 to a 3 and I was released. The ER prescribed Gabapentin 300 mg (3 times a day) which I started the evening of April 16. I have had less constant pain since leaving the ER and starting the Gabapentin, but I continue to have pain in the Trigeminal nerve areas and neck with some flare ups that reach a 7 out of 10 in pain. I am scheduled for an MRI on April 23 and a visit with the Neurologist on May 10.
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| 46 | 2021-04-18 | pain in extremity |
Patient received #2 of Pfizer COVID vaccine on 2/12/2021, reports that 2-2.5 weeks later he had bila...
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Patient received #2 of Pfizer COVID vaccine on 2/12/2021, reports that 2-2.5 weeks later he had bilateral leg pain + swelling. He was seen in hospital ER on 3/8/2021 and diagnosed with non occlusive dvt in distal fem vein of Right lower extremity
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| 46 | 2021-04-19 | weakness | fever, body aches, lack of energy |
| 46 | 2021-04-19 | bell's palsy | Bell's Palsy |
| 46 | 2021-04-19 | flushing |
"Administered - 12:02 Adverse event started - 12:05 Patient had flushing/sweating, lightheadedness. ...
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"Administered - 12:02 Adverse event started - 12:05 Patient had flushing/sweating, lightheadedness. Worked night shift per patient. BP 90/48 (57) -- > 101/65 (73), HR 71 -- >73, RR 16 -- > 16, O2 99% -- > 100%. Provided VSS, water, crackers. Patient stable, released from vaccination site."
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| 46 | 2021-04-19 | pain in extremity |
Developed left arm pain and swelling after 1st vaccine in left shoulder. Persisted longer than previ...
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Developed left arm pain and swelling after 1st vaccine in left shoulder. Persisted longer than previous reactions. Found to have blood clot in left brachial vein on 4/15/21 on ultrasound after evaluation by me
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| 46 | 2021-04-19 | tingling, numbness, pain in extremity |
Diarrhea came two days after for four days. Sore arm. Head felt numb-ish, tingly on right side and s...
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Diarrhea came two days after for four days. Sore arm. Head felt numb-ish, tingly on right side and sore shoulder/arm. Then, small bumps on head and headache. Then, five days or later large bumps formed on head. Top of head, then moved to right side of head, lymph nodes and right side of neck swelling. Very severe head ache 7 days later. Emergency call to doctor and doctor visit. Bumps moving and forming in different areas side of vaccine. Face swelling. Throat swelling...all on right side.
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| 46 | 2021-04-20 | inability to speak |
Pt recieved 2nd dose of pfizer vaccine on 4/14. on 4/15 pt had fever up to 103. Pt has had ongoing ...
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Pt recieved 2nd dose of pfizer vaccine on 4/14. on 4/15 pt had fever up to 103. Pt has had ongoing fevers since. On 4/20 pt became confused and displayed s/s of stroke. Brought to hospital by EMS and evaluated for stroke like sx. Pt was treated for stroke- given TPA and placed in ICU. CT showed show evolving subacute infarct. Pt has word difficulty, confusion, diaphoresis. Currently still in ICU.
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| 46 | 2021-04-20 | tingling, numbness |
Shingles -- onset began with headache on 3/19, blister outbreak on 3/20, nerve tingling and numbness...
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Shingles -- onset began with headache on 3/19, blister outbreak on 3/20, nerve tingling and numbness on 3/23. Diagnosed per Dr. on 3/23 with shingles and prescribed VALACYCLOVIR HCL (1GM) and PREDNISONE (30MG) for symptoms.
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| 46 | 2021-04-20 | tingling |
THE PATIENT STARTED TO HAVE BLURRY VISION AT ABOUT 10 MINUTES AFTER VACCINE, THEN TONGUE IN ONE SPOT...
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THE PATIENT STARTED TO HAVE BLURRY VISION AT ABOUT 10 MINUTES AFTER VACCINE, THEN TONGUE IN ONE SPOT ON FRONT TINGLING, STARTED TO GET TINGLING ARM. BP TAKEN AND AT 151/111 AT 10:45 AM. CALLED 911, SQUAD TOOK PATIENT AT AMBULANCE AND LEFT PROPERTY
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| 46 | 2021-04-21 | weakness |
Pt was nervous before getting shot. After receiving shot he was in a monitor area. He raised hand ...
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Pt was nervous before getting shot. After receiving shot he was in a monitor area. He raised hand and stated he felt weak. He was pale and diaphoretic. Helped him to ground and allowed to rest. Felt better. Pt evaluated by paramedics. VS @ 1107 HR 68, OxSat 99%, BP 96/47. @1115 Sit in chair. BP 104/56, HR 70, OxSat 100%. @ 11:45 Pt ambulated w/o difficulty. Taking bus home. Told to call nurse when he arrives home.
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| 46 | 2021-04-21 | tenderness |
In my left armpit I experienced soreness and swelling. I first experienced this on Sunday, April 19,...
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In my left armpit I experienced soreness and swelling. I first experienced this on Sunday, April 19, 2021 around 8am. As of April 22, 2021 I still have the swelling. My lymph node in my left armpit is still tender to the touch.
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| 46 | 2021-04-22 | pain in extremity |
After two hours of putting the first dose, I experienced headache, pain in the joints of the feet an...
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After two hours of putting the first dose, I experienced headache, pain in the joints of the feet and hands, abdominal pain in the lower part of the back. A little fever at night and nausea. I took acetaminophen for the fever and the pain subsided quite a bit in my symptoms.
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| 46 | 2021-04-22 | tremor | Body aches, joint pain, shaking, chills, cough, fatigue, shortness of breath on exertion |
| 46 | 2021-04-23 | burning sensation, weakness, feeling of body temperature change |
Pt became nauseated, c/o burning hot/cold, diaphoretic, head spinning, feeling weak. PB 170/100 lef...
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Pt became nauseated, c/o burning hot/cold, diaphoretic, head spinning, feeling weak. PB 170/100 left arm. Pt still symptomatic and was taken to Emergency Department.
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| 46 | 2021-04-24 | numbness |
Loss of hearing in left ear; tinnitus/echoing; numbness around area of left ear; This is a spontaneo...
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Loss of hearing in left ear; tinnitus/echoing; numbness around area of left ear; This is a spontaneous report from a contactable health care professional (patient). A 46-year-old male patient received the second dose BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: El3248), via an unspecified route of administration, administered in the left arm on 18Jan2021 as a single dose for COVID-19 immunization. Medical history included Hashimoto's disease, high cholesterol and is prediabetic all from an unknown date and unknown if ongoing. The patient has no known allergies. The patient did not have COVID prior to vaccintion and has not been tested for COVID post vaccination. Concomitant medications included empagliflozin (JARDIANCE); levothyroxine (manufacturer unknown); metoprolol (manufacturer unknown); rosuvastatin (manufacturer unknown) and fish oil (OMEGA 3 [FISH OIL]), all taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of bnt162b2 (lot number: Es1685) on 28Dec2020 at 12:00 PM via intramuscular route on the right arm for COVID-19 immunization. The patient experienced loss of hearing in left ear, tinnitus/echoing and numbness around area of left ear all on 22Mar2021 at 12:00. The ENT prescribed prednisone 10mg as treatment for the events. The outcome of the events was not recovered.; Sender's Comments: Based on the information currently available, a causal association between the reported events and BNT162B2 cannot be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and investigators, as appropriate.
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| 46 | 2021-04-26 | flushing |
Client reported receiving Pfizer COVID 19 vaccine on 4/22/2021 in right arm. On 4/23/2021 starting h...
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Client reported receiving Pfizer COVID 19 vaccine on 4/22/2021 in right arm. On 4/23/2021 starting having body aches, dizziness, headache and filling flushed. On 4/24/2021 lip swelling started and now both lips, sides of mouth with clear blisters. Per Client, allergic to shellfish and no other known past medical history. Per Client has taken Benadryl and Ibuprofen, but symptoms are still presenting. PHN recommended that Client follow up with PCP, be seen at urgent care, ER and to call 911 with any respiratory concern or medical emergency. Client verbalized understanding information provided by PHN and plans to follow up and seek medical attention.
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| 46 | 2021-04-26 | pain in extremity | Itching and discharge from right eye Pain in left calf (next day) |
| 46 | 2021-04-26 | pain in extremity |
Pain began this morning in groin on left leg. It now feels like I have severe (or at least what I as...
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Pain began this morning in groin on left leg. It now feels like I have severe (or at least what I assume it feels like) arthritis in my left hip. Hard to walk.
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| 46 | 2021-04-27 | feeling jittery |
After both shots. About 1-2 minutes after I started feeling nauseous, shaky, dizzy and then my heart...
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After both shots. About 1-2 minutes after I started feeling nauseous, shaky, dizzy and then my heart pounding out of my check for 30-40 seconds. My heart settled down and I was shaky and jittery the rest of the day.
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| 46 | 2021-04-27 | one side paralysis |
I started to have weakness on my left side around 9 hours after receiving the vaccine. I went to the...
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I started to have weakness on my left side around 9 hours after receiving the vaccine. I went to the hospital and was told I had a stroke in the right side of my brain from a clot in my brain, which they took the clot out using a catheter through my leg. I am currently undergoing rehabilitation at a rehab hospital.
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| 46 | 2021-04-27 | numbness |
Patient received his second COVID shot and waited the 15 minutes with no issues. He went out to his...
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Patient received his second COVID shot and waited the 15 minutes with no issues. He went out to his car and was about to drive off when he informed his wife that the side of his face felt a little numb. He had no other symptoms. His wife suggested he come back inside and ask what to do. Based on his symptoms, I asked him to have a seat for another 15 minutes to see how he felt. He was completely coherent. After checking on him again, he reported no change in symptoms. A few minutes later, around 12;45 pm, his wife said they would contact his doctor from the car. He left and I tried calling him around 4pm to ask how he was doing. I had informed him to contact his doctor, go to the ER if his symptoms worsened or stayed the same after a little while.
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| 46 | 2021-04-27 | migraine, tremor |
I received my second Pfizer COVID vaccine shot at 11:00 am. The first 12 hours after everything was...
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I received my second Pfizer COVID vaccine shot at 11:00 am. The first 12 hours after everything was normal and fine. I ate dinner and got ready for bed. But then, starting 12 hours after my shot, starting at 11:00 pm, I began to have severe chills and total body shakes. I was curled up into a ball under blanket, both freezing cold and profusely sweating. My breathing was very fast and I couldn't slow it down. My stomach was very upset and I was unable to eat anything. At 3:30 am, I got a severe Migraine which lasted until 6:00 am. I continued to feel very ill the whole rest of the day. Finally, around 9:00 am some 34 hours after syptoms began, they left me.
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| 46 | 2021-04-28 | weakness |
Patient received first dose of Pfizer vaccine and started to feel dizzy, weak, nauseous, and have sl...
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Patient received first dose of Pfizer vaccine and started to feel dizzy, weak, nauseous, and have slight chills about 5 minutes after receiving vaccine. Patient's symptoms were on and off. Blood pressure was taken and fluctuating. Paramedics were called per patient's request. Patient did not leave with paramedics and signed waiver. BP 1: 90/60 Pulse 1:104 BP 2: 124/86 Pulse 2:74 BP 3: 114/74 Pulse 3: 61 BP 4: 109/75 Pulse 4: 84
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| 46 | 2021-04-28 | bell's palsy, face paralysis | Right side of face muscle nerve weakening. Got diagnosed with Bell?s Pallsey |
| 46 | 2021-04-28 | discomfort, pain in extremity |
46 year old male with history of depression, polio, HTN/HLD, chronic lung disease 2/2 remote PNA, a...
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46 year old male with history of depression, polio, HTN/HLD, chronic lung disease 2/2 remote PNA, and cirrhosis suspected 2/2 schistosomiasis, who presents with 1wk of dyspnea, w/ waxing waning subjective fevers. Per ED Note: Endorses chronic fatigue until 4/16 when he received first dose of Covid vaccine (Pfizer). Since then, pt reports persistent dyspnea, worsening fatigue. Reports 2 days of left-sided chest pain w/ periumbilical abd pain and enlarging abdomen. Pt believes these are 2/2 covid vaccination. Chest pain is described as constant generalized discomfort under left breast that worsens with pressure. Also worse with deep inspiration. No radiation or migration since onset. Pt describes abdominal pain as periumbilical tightness, "pain". Describes subjective, unmeasured fevers that "come and go" over last week. When asked to repeat the story of what happened on arrival to the unit, wife speaks for the patient since he is slightly dyspnic. States this morning, went to small clinic, husband had a headache and slight fever. Clinic said to come in to the big hospital. Fever and pain in legs and head, started a few days after he got the covid vaccine. The fever came and went. Didn't measure the fever. Also has some problems with Abdominal pain - doesn't know how to describe it. Feels like stomach ache. Stomach pain is getting better. Has since gone away since arriving to the hospital. He denies any cough, denies chills, denies nausea or vomiting. States he took some medications at home for constipation because he felt like he couldn't go. From the conversation it appears he does not take lactulose for HE, more for constipation. ED workup included an Xray, CT C/A/P with multifocal lung lesions suspicious for multifocal pneumonia. Lactate of 16. Na of 124. Noted to be anemic and thrombocytopenic. UA cloudy, pyuric, w/protien >100. Chest and abdominal pain resolved by the time pt was examined on the floor. Still tachypnic and tachycardic. Stated most bothersome was feeling anxious. Has anxiety at a baseline. Not complaining of any pain at the moment. Cannot describe chest pain in more detail, put his hand over the right side of his chest and presses on it but does not say if it hurt more when he would press on it, does not say it was reproducible. Not painful when he touches or presses on it now. Per chart, patient recently re-established care after long-time from follow up during pandemic. At visits last month c/o gingival bleeding, fatiguem & found to have Hgb drop from 13 in 2018-> 9.7 on 3/2/21. Referred for EGD but cancelled due to anxiety. I am the Infectious Diseases attending asked to see him for septic shock. He developed septic shock and respiratory failure requiring mechanical ventilation and 3 vasopressors. He has evidence of DAH, DIC, acute renal failure, progressive liver failure and he has Klebsiella pneumoniae bacteremia.
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| 46 | 2021-04-28 | pain in extremity |
Regular pain feeling; Headache; Muscle pain; Calf feels tight, stiff, it feels like dead weight; Cal...
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Regular pain feeling; Headache; Muscle pain; Calf feels tight, stiff, it feels like dead weight; Calf feels tight, stiff, it feels like dead weight; Pain running up the right arm up to the shoulder/Calf pain; He asked if someone can tell him if it is a blood clot in the back of his calf; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm (shoulder) on 12Mar2021 10:07 (Lot Number: EN6202) as single dose for covid-19 immunization. There were no medical history and concomitant medications. The patient has no prior vaccinations within 4 weeks. The patient was not sick at time of vaccination. The patient reported that on 12Mar2021, he has been feeling the regular pain feeling, a headache, muscle pain before, it comes and goes. However, he said that the last few days (2021), there had been, by his calf muscle in the back there, they've been tightening, like stiffening up on him when he's sleeping. His calf feels tight, stiff, it feels like dead weight. It wakes him up at times. He also reported pain running up the right arm up to the shoulder on unknown date in 2021. He was just curious in terms of what that might be. He asked if someone can tell him if it is a blood clot in the back of his calf. The headache went away after 2-3 days. He also reported that his eyes also hurt a little bit and was the same time frame as the headache (onset date reported as 12Apr2021: after the second dose, pending clarification). He stated that those things were just mild, nothing major. He did not take anything for these. He confirmed he no longer had muscle pain. He just has pain behind the calf and right arm up to his shoulder. His calf pain, started to feel tight, started within the last 2- 3 weeks (2021). The arm pain in right arm up to shoulder started maybe within 2 days. The patient received the second dose on 02Apr2021. Outcome of the events muscle pain and headache was recovered in Mar2021, events pain running up the right arm up to the shoulder/Calf pain was not recovered, and outcome of other events was unknown.
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| 46 | 2021-04-29 | migraine | Fever, chills, migraine |
| 46 | 2021-04-29 | unresponsive to stimuli, feeling hot |
I experienced mild fatigue and chills about 12 hours after the shot. No treatment necessary. I wok...
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I experienced mild fatigue and chills about 12 hours after the shot. No treatment necessary. I woke up at approx. 1:30 am feeling very warm. I got out of bed. While in the bathroom, I began to feel very lightheaded and passed out while I was washing my hands. My wife heard me crash to the floor. I returned to consciousness but passed out again while trying to stand, unresponsive to my wife. I returned to consciousness after about 1 minute. I stayed sitting for several minutes while my wife brought me some water. I felt thirsty and it's possible I was dehydrated, but I had been drinking fluids (water) the day before as normal. Due to the two fainting spells and a possible head injury, I went to the Emergency Room for treatment at approx. 2 am.
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| 46 | 2021-04-30 | pain in extremity |
Low grade Fever; Arm so sore that you dont want to move it; Body Aches; Fatigue; Headache; Metallic ...
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Low grade Fever; Arm so sore that you dont want to move it; Body Aches; Fatigue; Headache; Metallic Taste in my mouth; Nasal Drip; Nasal Drip with Nausea; This is a spontaneous report received from a contactable consumer (patient). A 46-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number ER8727) via an unspecified route of administration in the right arm on 30Mar2021 at 08:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included sarcoidosis from an unknown date and unknown if ongoing. Prior to vaccination the patient was not diagnosed with COVID-19 and had not received any other vaccines in the 4-weeks prior to the COVID vaccine. Concomitant medications included atorvastatin, pantoprazole, fluticasone propionate (FLONASE), and cetirizine hydrochloride (ZYRTEC) all from unknown dates for unknown indications. The patient previously received morphine on an unknown date for an unknown indication and experienced drug allergy, and the first dose of BNT162B2 (lot number EN6208) on 09Mar2021 at 13:15 (at the age of 45-years-old) for COVID-19 immunisation. On 30Mar2021 at 08:45 the patient experienced low grade fever, arm so sore that you don't want to move it, body aches, fatigue, headache, metallic taste in their mouth, further reported as nothing tasted good yesterday (as of 31Mar2021), and nasal drip with nausea. No treatment was provided for the events. The outcomes of low-grade fever, arm so sore that you don't want to move it, body aches, fatigue, headache, metallic taste in their mouth, and nasal drip with nausea were not recovered. It was also reported the patient had not been tested for COVID since vaccination. No follow-up attempts are needed. No further information is expected.
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| 46 | 2021-04-30 | pain in extremity |
calf feels tight, stiff, it feels like dead weight/started within the last 2- 3 weeks; calf feels ti...
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calf feels tight, stiff, it feels like dead weight/started within the last 2- 3 weeks; calf feels tight,; pain running up the right arm up to the shoulder; pain running up the right arm up to the shoulder/his calf pain, started to feel tight, started within the last 2- 3 weeks; He asks if someone can tell him if it is a blood clot in the back of his calf; his eyes also hurt a little bit; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose at the age of 46-years-old via an unspecified route of administration, administered in arm left on 02Apr2021 (Batch/Lot Number: ER8734) as single dose for covid-19 immunisation. There was no medical history reported. There were no concomitant medications. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 12Mar2021 (lot number: EN6202) at the age of 46-years-old for covid-19 immunisation and experienced If it is a blood clot in the back of his calf, Regular pain feeling, Headache, Muscle pain, Calf feels tight, stiff, it feels like dead weight, Pain running up the right arm up to the shoulder and Calf pain, started to feel tight. The patient reported that he has been feeling the regular pain feeling, a headache, muscle pain before, it comes and goes on 12Mar2021. However, he says that the last few days there had been, by his calf muscle in the back there, they've been tightening, like stiffening up on him when he's sleeping on an unspecified date. It wakes him up at times. He also reports pain running up the right arm up to the shoulder on an unspecified date. He says he is just curious in terms of what that might be. He asks if someone can tell him if it is a blood clot in the back of his calf on an unspecified date. The headache went away after 2-3 days. He says his eyes also hurt a little bit on 12Apr2021 and was the same time frame as the headache. He says those things were just mild, nothing major. He did not take anything for it. He confirmed he no longer has muscle pain. He just has pain behind the calf and right arm up to his shoulder. He says his calf pain, started to feel tight, started within the last 2- 3 weeks. The arm pain in right arm up to shoulder started maybe within the last 2 days. The outcome of the events was unknown. Follow-up attempts completed. No further information expected.
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| 46 | 2021-04-30 | tingling, numbness |
Numbness and Paresthesia bilateral feet and shins; Numbness and Paresthesia bilateral feet and shins...
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Numbness and Paresthesia bilateral feet and shins; Numbness and Paresthesia bilateral feet and shins; right lower extremity weakness; cough; shortness of breath; chest tightness; confusion; This is a spontaneous report from a contactable physician reporting for a patient. A 46-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Arm Right on 13Apr2021 13:00 (Batch/Lot Number: EW0162) as SINGLE DOSE for covid-19 immunisation at 46 years old. Medical history included DJD cervical spine and Raynaud's Phenomenon from an unknown date. Concomitant medications included amlodipine taken for an unspecified indication, start and stop date were not reported. The patient experienced numbness and paresthesia bilateral feet and shins; right lower extremity weakness, cough, shortness of breath, chest tightness, confusion on 13Apr2021 13:15. Treatment included albuterol. The patient was hospitalized for the events on an unspecified date for 2 days. The patient underwent lab tests and procedures which included sars-cov-2 antibody test (Nasal Swab): negative on 16Apr2021 and 17Apr2021, and blood test (SARS-CoV-2 antibody test) negative on 16Apr2021.Outcome of the events was recovered with sequelae (Recovered with lasting effects) on an unspecified date in 2021.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment. Based on the available information and the temporal association of BNT162B2 administration to the events, a possible contribution of the drug to the events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 46 | 2021-05-01 | muscle spasms, pain in extremity |
Patient presented to the emergency department on 4/10 with a complaint of left leg pain. Patient re...
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Patient presented to the emergency department on 4/10 with a complaint of left leg pain. Patient reports onset of symptoms on Wednesday (4/7). He states that initially it just felt like a cramp in his calf. He states that over the past couple days, the pain has gotten significantly worse. He states the pain is now sharp and severe in nature. He states that he is having due to the severity of the pain. He states the pain is now moving up into his medial thigh. Patient states that around noon on 4/10, he began having chest pain and shortness of breath. Patient describes a tightness across his chest and states that he cannot breathe associated with this. Patient does have a history of asthma and states that he has had a couple of episodes like this in the past. Patient also reports a history of diabetes, hypertension. Patient does report a family history of coronary artery disease as well as a family history of blood clots. He received his Pfizer Covid vaccine 2nd dose on 4/9/2021 (Lot # ER8729) and 1st dose (Lot # EN6204) given on 3/12/2021 at an outside facility He does report arm soreness but is otherwise doing well. No recent travel. No recent immobilization. Upon evaluation in the ED, he was noted to have positive US for DVT in the LLE. Follow up CTA Chest was positive for bilateral lobar and segmental PE with right heart strain. CVM was consulted for possible PE intervention evaluation. Patient started on therapeutic Lovenox, but discharged home on 4/11 with Eliquis. . The next day 4/12/21 he returned to ED for SOB/Wheezing and LLE pain. On 4/15/21 he underwent EKOS, IVCF and iliac stent placement per Vascular surgery and subsequently sent home on Eliquis 4/16/21. Pt returned to the ER again 4/21/21 for recurrent SOB. CTA chest with no significant change in clot burden, no associated hypoxia.
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| 46 | 2021-05-01 | muscle spasms |
Red rash, tongue swelling, nausea, vomiting, diarrhea, muscle cramps, dizziness, fever, chills. Too...
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Red rash, tongue swelling, nausea, vomiting, diarrhea, muscle cramps, dizziness, fever, chills. Took Benadryl tablets about an hour after receiving the vaccine. Took Tylenol for the fever. Took some nausea medication during the night about 6 hours after receiving the vaccine to stop the vomiting.
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| 46 | 2021-05-02 | tingling |
transverse myelitis - potentially related to immunosuppression from Humira, the herpes simplex virus...
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transverse myelitis - potentially related to immunosuppression from Humira, the herpes simplex virus or the vaccine (or combination of all 3). Sx included areflexia, bilateral paresthesia (legs and feet), double vision, cord damage from cervical region to conus of the cord. Also developed urinary retention.
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| 46 | 2021-05-03 | speech disorder |
I had a Stroke; Blood clot travelled to my brain; effected left side of my body; ability to speak; T...
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I had a Stroke; Blood clot travelled to my brain; effected left side of my body; ability to speak; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: ER 8729), via an unspecified route of administration in left arm on 10Apr2021 (at the age of 46-years-old) as single dose for covid-19 immunisation. The vaccination facility type was a pharmacy/drug store. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. The patient did not have covid prior vaccination. The patient had no other vaccine in four weeks and no other medications in two weeks. The patient had a stroke. Blood clot travelled to his brain and effected left side of his body and ability to speak on 15Apr2021 at 17:30. The events resulted to emergency room/department or urgent care, hospitalization for 3 days, life threatening illness (immediate risk of death from the event), disability or permanent damage. The patient received unspecified treatments for the event. Covid test post vaccination on 15Apr2021 with result of negative. The outcome of the events was recovering.
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| 46 | 2021-05-04 | night sweats |
This is a spontaneous report from a contactable consumer (patient's fiance). A 46-year-old male pati...
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This is a spontaneous report from a contactable consumer (patient's fiance). A 46-year-old male patient received the first dose bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 18Apr2021 11:20 (Lot Number: EW0162) (received at the age of 46-years-old) as SINGLE DOSE for COVID-19 immunisation. Medical history included right knee pain. Concomitant medications were not reported. The patient received the Pfizer 1st shot 18Apr2021 11:20 am. On 19Apr2021, at midnight, he had low grade fever then swelling right leg. On the day of the report, 20Apr2021, he had swelling to both legs. The patient had taken ibuprofen as treatment beside propping legs up. The reporter wanted more information on the swelling and if it's related to taking ibuprofen. It was further reported that the patient experienced severe swelling from the knees down to the calves on both legs on 19Apr2021. He also experienced night sweats, fever, lightheadedness and dizziness on 19Apr2021. They want to know if there are any reports regarding the swelling side effects and if it is from the vaccine. The first dose of the vaccine was given 2 days ago (18Apr2021) and the second dose is due on 09May2021. The patient got his first shot on 18Apr2021 about 11:20am. After about 15 hours he developed swelling in one leg, she later clarified this to be his right leg, and now reports that both of his legs are swollen at the time of report (20Apr2021). She noted that patient told her his legs are not painful. She doesn't know if it's a blood clot or if they needed to go to the hospital. She also wanted to know if there is information about this as a side effects or if other people are having this too. She then reported that the patient started experiencing a fever, profuse sweating, and was spacey about 12 hours after the vaccine, a little after midnight 19Apr2021. She doesn't know if the dehydration made it worse. His fever was low-grade 99.8 degrees and lasted 4 and a half to 5 hours and has now resolved. When asked if patient received any treatment for fever, caller said it was so recent, and that was listed as a common side effect that goes away. Reported the patient drank fluids and she kept an eye on him. Leg swelling was about 15 hours after the vaccine, early morning 19Apr2021. She noted that the swelling in the right leg got bigger and didn't go down, but the left leg did. But today the left was more swollen and more prominent today. She further clarified that the patient takes ibuprofen for pre-existing right knee pain. Caller also reported that the patient propped his legs to alleviate the swelling, it has improved some but the swelling did not go away. The adverse events did not require a visit to the physician office or emergency room. Outcome of the event fever was resolved on 19Apr2021 (lasted 4 and a half to 5 hours); outcome of the event "severe swelling from the knees down to the calves on both legs" was not resolved; outcome of the remaining events was unknown.
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| 46 | 2021-05-10 | bell's palsy |
classic right sided Bell's palsy with right sided weakness; This is a spontaneous report from a cont...
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classic right sided Bell's palsy with right sided weakness; This is a spontaneous report from a contactable Physician reporting for a patient (reporter's son.) A 46-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 intramuscular, administered in the left arm on 04Apr2021 14:45 (Lot Number: ER8732) as a single dose (at the age of 46-years-old) for COVID-19 immunisation. Medical history included ongoing gout (controlled), and Bell's palsy from an unknown date (patient had Bell's palsy 13 years before). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included allopurinol (300 mg) at 300 mg from an unknown date for gout. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 12Apr2021 the patient experienced Bell's palsy. The patient started symptoms on 12Apr2021 and progressed to facial paralysis on 23Apr2021 which was finally diagnosed as Bell's Palsy. The Bell's Palsy is stable and has not improved much yet. Clinical course is as follows: on Monday, 12Apr2021 one and a half weeks after the vaccine the patient's symptoms began, he had minimal symptoms on 10Apr2021 and on 23Apr2021 he had facial paralysis and on that day he started treatment. On Friday (date not specified) the patient had facial weakness. The reporter considered the event non-serious. The reporter would like to know the post-marketing incidence of Bell's palsy and the reporter was trying to decide whether the patient (reporter's son) gets second dose of Pfizer Covid BioNTech Vaccine or forgoes it. Therapeutic measures were taken as a result Bell's palsy included treatment with high-dose prednisone and valicyclovir (VALTREX). The clinical outcome of the Bell's palsy was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The reporter stated that this (Bell's palsy) may be a random event or a related event. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on chronological connection to the vaccine a causal relationship between event Bell's Palsy and BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 46 | 2021-05-10 | unresponsive to stimuli, flushing, seizure |
Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension...
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Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Systemic: Seizure-Medium
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| 46 | 2021-05-13 | pain in extremity |
Red rash and itching on left arm went away after two days then 2 days later came back bigger and red...
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Red rash and itching on left arm went away after two days then 2 days later came back bigger and redder than before and lasted about 4 days. Has cleared up since. 1st day was very painful also.
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| 46 | 2021-05-14 | bell's palsy |
Diagnosed with Bells Palsy; This is a spontaneous report from a contactable consumer (patient). A 46...
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Diagnosed with Bells Palsy; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in arm right on 23Apr2021 18:00 (at the age of 46-year-old) (Lot Number: EW0170) as single dose for covid-19 immunisation. The patient's medical history was not reported. Concomitant medications was none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient was diagnosed with bells palsy on 04May2021 08:00. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of diagnosed with bells palsy, medication steroid and antiviral were used. Event outcome was not recovered.
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| 46 | 2021-05-14 | discomfort |
mental dullness; Severe fatigue; muscle aches; body heaviness; This is a spontaneous report received...
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mental dullness; Severe fatigue; muscle aches; body heaviness; This is a spontaneous report received from a contactable consumer reported for himself and a other healthcare professional. A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: EW0170) at left arm on 26Apr2021 13:00 at single dose for COVID-19 immunization in Hospital. Medical history and Concomitant medications were none. No Known Allergies. the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. the patient did not receive within 2 weeks of vaccination. It was reported nothing that made him feel in danger. Severe fatigue, mental dullness, body heaviness, muscle aches, all on 27Apr2021, 06:00 AM. Received shot at 1pm. Bicycle ride that late afternoon. No side effects until next morning. Major effects lasted until about 2pm the next day. All was back to normal the following morning after a normal night's sleep. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has note been tested for COVID-19. No treatment received for the events. Outcome of the events was recovered on 28Apr2021. Batch/Lot number has been obtained. further information has been requested.
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| 46 | 2021-05-21 | muscle spasms |
Almost fainting 3 minutes/Almost fainted/Really close to blacking out; Almost passed out; Nauseated/...
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Almost fainting 3 minutes/Almost fainted/Really close to blacking out; Almost passed out; Nauseated/Swirling strong nausea through the body up to the chest; Rapid heart rate; Hyperventilation; Labored breathing; 5-10 minutes before able to uncramp his hands; Waves of the feelings came throughout the day; This is spontaneous report received from a contactable consumer (patient). A 46-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: ER8733), via an unspecified route of administration, administered in Arm Left on 15Apr2021 11:00 as single dose for covid-19 immunization. Medical history included sensitivities to ephedrine from an unknown date and unknown if ongoing. The patient had no concomitant medications. The patient experienced almost fainting 3 minutes/almost fainted/really close to blacking out, nauseated/swirling strong nausea through the body up to the chest, rapid heart rate, hyperventilation, labored breathing, 5-10 minutes before able to uncramp his hands, waves of the feelings came throughout the day, almost passed out/ really close to blacking out; all on 15Apr2021. The events were not required a visit to emergency room, nor physician office. Caller is a 47 years old patient who received the 1st dose of the Pfizer Covid vaccine on 15Apr2021. He complained of feeling nauseated, and rapid heart rate, with hyperventilation, and almost fainting 3 minutes after the 1st dose of the Pfizer Covid vaccine. This lasted approximately 15 minutes. 3 minutes after receiving a vaccine. He started to complaint about feeling nauseated. He started rapid heart rate which caused him to have hyperventilation and almost fainted. The episode last for 15 minutes and he just want to go and report it. Consumer confirmed it was the Pfizer Covid19 vaccine. The consumer wasn't still experiencing the side effects. They lasted to 5pm. I got my shot at 11am. The event was no longer persisting but he was wanting to understand the effect of the second shot, the consumer wasn't took any treatment for adverse event. Caller states that he is calling about the Covid Vaccine. Says with the first round of the vaccine he had an adverse event. He is looking to Pfizer and his doctor for some feedback to understand whether or not he should get the second dose. Says that about three minutes after the vaccine he felt a swirling, strong nausea throughout his body up to his chest. He had labored breathing and a really fast uncontrolled heart rate for about 5 minutes. States he was hyperventilating and almost passed out. He had to sit on the ground of the parking garage where he had gotten his vaccine. About 5-10 minutes later he was finally able to uncramp his hands. States that before the vaccine he was calm and not at all in an elevated state. States he is wondering about the second dose being stronger. He almost blacked out after the first dose. States it was close to the limit of what he could tolerate. States he needs further details. He was reading about clinical trials and some doctors. States that he did not have all the symptoms of anaphylaxis that they described. Says his symptoms lasted about 5 minutes or so. About 10-15 minutes later he was recovered. Says waves of these feelings came over him throughout the day. Says they decreased each time and ended that evening around 1700. Caller says he did not go to the Emergency Room when it happened. The nurses at the vaccination site attended him. At the end of the call the caller mentions that he has a sensitivities to ephedrine. States he does not take any Sudafed or Dayquil or anything like that. States he didn't know if that was relevant to mention or if anything like that is in the vaccine to make him have the response that he did. History of all previous immunizations with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. No prior Vaccinations (within 4 weeks). No family medical history relevant to events. No Relevant Tests. The outcome of events was resolved on 15Apr2021.
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| 46 | 2021-05-23 | numbness |
Facial numbness on and off for 10 days. Hands and Feet numbness approximately 9 days after injection...
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Facial numbness on and off for 10 days. Hands and Feet numbness approximately 9 days after injection. Chest pressure, including pressure into my back directly behind the heart and my left shoulder 9 days after injection. Went to the Emergency Room and had 3 EKGs, a chest x-ray, and blood work. Chest, Back, and Shoulder pressure continues on and off to this day - over one month since the injection.
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| 46 | 2021-05-24 | weakness | Shortness of breath, heavy weight on my chest, feeling weak, needed to sit or lay down. |
| 46 | 2021-05-24 | pain in extremity |
PT GOT THE VACCINE ELSEWHERE: PT ALSO STATES, THIS IS HIS 2ND DOSE OF pziefer HE STATES HE HAD PAIN ...
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PT GOT THE VACCINE ELSEWHERE: PT ALSO STATES, THIS IS HIS 2ND DOSE OF pziefer HE STATES HE HAD PAIN ON BOTH LEGS AFTER A COUPLE OF HOURS OF THE VACCINE TODAY HE COMES IN WITH BOTH FEET SWOLLEN AND PAIN
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| 46 | 2021-05-28 | weakness |
Full Fibromyalgia flare up. Extreme Pain over 10 on 1-10 scale. Incapacitated. I feel this should ...
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Full Fibromyalgia flare up. Extreme Pain over 10 on 1-10 scale. Incapacitated. I feel this should have be told. Especially for other people with the condition.
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| 46 | 2021-05-28 | pain in extremity |
I only slept 1 hour; My arm, head and back hurt.; My arm, head and back hurt.; My arm, head and back...
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I only slept 1 hour; My arm, head and back hurt.; My arm, head and back hurt.; My arm, head and back hurt.; Dry mouth; coughing; random thoughts; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration, administered on the left arm on 15May2021 12:00 as 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 15May2021 12:15, the patient only slept 1 hour, his arm, head and back hurt. Dry mouth, coughing, random thoughts. He felt like he was dying over here. Events were considered serious, disability. No treatment was received for the events. The facility where the vaccine was administered was in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications the patient received within 2 weeks of vaccination. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. Outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 46 | 2021-05-30 | pain in extremity, feeling cold | Dizziness....tired....soar arm......chills.......low grade fever |
| 46 | 2021-05-31 | migraine | Headaches, Migraines, Chills |
| 46 | 2021-05-31 | pain in extremity |
everything hurts; Ache; her husband said this morning he had a bad headache; her husband said his sk...
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everything hurts; Ache; her husband said this morning he had a bad headache; her husband said his skin was feeling tight this morning; injection site pain after receiving the COVID-19 Vaccine yesterday; Her husband developed an itchy, red, rash on his abdomen & shins about 2 hours after receiving his 2nd COVID-19 Vaccine. She said the rash is red, raised bumps. was reported as worsened; he has a charley horse-type pain in his left arm; he has a charley horse-type pain in his left arm; her husband said he got itchy immediately after receiving his COVID-19 Vaccine yesterday; Her husband developed an itchy, red, rash on his abdomen & shins about 2 hours after receiving his 2nd COVID-19 Vaccine. She said the rash is red, raised bumps; Her husband developed an itchy, red, rash on his abdomen & shins about 2 hours after receiving his 2nd COVID-19 Vaccine. She said the rash is red, raised bumps; her husband had red, raised hives on both sides of his abdomen, and both his shins; She said her husband said his skin burned really bad; her husband said he got itchy immediately after receiving his COVID-19 Vaccine yesterday was reported as worsened; This is a spontaneous report from a contactable consumer. This consumer reported for a 46-years-old male patient (husband) received Second dose (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Lot Number: EN5318) on 12Jan2021 at 1:00PM (at the age of 46 years) on unspecified route in the left arm as a 2nd dose, single for COVID-19 Immunization. Medical history included ongoing Psoriasis, her husband doesn't have any allergies, except for Penicillin. Concomitant medications were not reported. The patient previously took her first dose on 12Jan2021 between 1:00-2:00PM (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Lot Number: EL3302) on unspecified route in the left arm as a 1st dose, single for COVID-19 Immunization and also experienced Injection site pain, got itchy immediately, a week after her husband received his first COVID-19 Vaccine dose, he said he felt so bad, her husband said he felt run down a week after he received his first COVID-19 Vaccine dose, Rash. On 02Feb2021 patient experienced her husband said he got itchy immediately after receiving his COVID-19 Vaccine yesterday was reported as worsened, Her husband developed an itchy, red, rash on his abdomen & shins about 2 hours after receiving his 2nd COVID-19 Vaccine. She said the rash is red, raised bumps, her husband had red, raised hives on both sides of his abdomen, and both his shins, he has a charley horse-type pain in his left arm, her husband said his skin was feeling tight this morning, on 03Feb2021 her husband said this morning he had a bad headache, everything hurts, Ache, her husband said his skin was feeling tight this morning. On Feb2021 she said her husband said his skin burned really bad. Reported her husband had the same experience after he received his first COVID-19 Vaccine dose on 12Jan2021, clarifying her husband said he got itchy immediately after receiving the COVID-19 Vaccine. She said her husband has had psoriasis for a long time. She said her husband has had psoriasis outbreaks before, but not in that area of his body. She said her husband usually has a psoriasis outbreak at his waist where his belt buckle is located, as well as, his elbows, and knees. And her husband didn't think anything of his itchiness and rash after he received his first dose of the COVID-19 Vaccine because he has a history of psoriasis. She said the rash he developed after his first COVID-19 Vaccine dose went away. Reported her husband used (Name) soap and Calamine lotion for the hives and rash on his abdomen and both his shins. She said the rash went away after 2-1/2 weeks. She clarified her husband bathed with Ivory soap, Clean Body Wash (Lot Number: 90845395GC, Expiration Date: Unknown) and applied Calamine lotion to his rash. She said he used the Calamine Plus Itch Relief pink-colored Calamine lotion (Lot Number: A49014, Expiration Date: 2023) only one day and then switched to the clear Calamine lotion with Pramoxine HCL 1% and Zinc Acetate 0.1% (Lot Number: A60023, Expiration Date: Sep2024), so he wouldn't stain his work clothes. Reported her husband told her when the itchiness and rash came back after he received his second COVID-19 Vaccine yesterday that he thinks he is allergic to the COVID-19 Vaccine and also her husband's rash is on both sides of his left and right upper abdomen, between his ribs and hips, and on both his left and right shins. Reported a week after her husband received his first COVID-19 Vaccine dose, he said he felt so bad, and felt run down. She said he was told at that time what to expect after receiving the COVID-19 Vaccine, and after a couple days he was OK. Reported today her husband said he can't move, and that everything hurts, and that he is achy. She said her husband's breathing is OK, so he is not having an anaphylactic reaction. She said her husband said his left arm was so painful with the first COVID-19 Vaccine dose, that he said couldn't put on his shirt. Reported her husband told her he doesn't want to go to the doctor. She said she told him he needs to see the doctor so he can have an allergy panel done. her husband has the bad rash at his waist, so his pant's are touching his waist, and it is uncomfortable. She said her husband said his skin is itching and burning at the same time. She said it wasn't until after receiving his second COVID-19 Vaccine dose that he made the connection with the itchiness and rash he had after receiving his first COVID-19 Vaccine dose. Reported they changed the filter for their showerhead in the bathroom to make sure it wasn't their public water causing the itchiness and rash and looked online for the Pfizer COVID-19 Vaccine ingredients and were confident in taking the COVID-19 Vaccine. She said the CDC had listed that a person can have hives and reactions like the itching and rash. The clinical outcome of the events her husband said this morning he had a bad headache, injection site pain after receiving the COVID-19 Vaccine yesterday, he has a charley horse-type pain in his left arm, her husband said his skin was feeling tight this morning, her husband said he got itchy immediately after receiving his COVID-19 Vaccine yesterday was reported as worsened, Her husband developed an itchy, red, rash on his abdomen & shins about 2 hours after receiving his 2nd COVID-19 Vaccine. She said the rash is red, raised bumps. was reported as worsened, She said her husband said his skin burned really bad were unknown. However, the outcome of the rest all events were not recovered.
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| 46 | 2021-06-01 | muscle spasms, numbness, tingling, tremor |
Spasms in hands and feet/spasms in his feet was a weird sensation like little explosions going off, ...
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Spasms in hands and feet/spasms in his feet was a weird sensation like little explosions going off, like a nerve issue, around feet, toes, and ankles; Both hands went numb; Both hands went numb and were tingling quite a bit and the next day when he woke up it was worse; He is having the tremors around ankles and feet; It is very uncomfortable and has not been able to sleep well because of it.; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EW0183), via intramuscular route administered in left arm (left shoulder as reported) on 17May2021 (age 46-year-old at time of vaccination) (in noon as reported) as single dose for preventative/COVID-19 immunisation. Medical history included had an allergy to penicillin and that was when he was a child, he thinks he had a rash. He does not know if he was still allergic. Prior Vaccinations (within 4 weeks) were none. Concomitant medications were none. It was reported that the evening after getting the first shot on 17May2021, both hands went numb and were tingling quite a bit and the next day when he woke up it was worse. On the third day after getting the shot he started getting and was still have spasms in hands and feet on 20May2021. The spasms in feet was a weird sensation like little explosions going off, like a nerve issue, around feet, toes, and ankles, stated it was also in his hands but not quite as much in hands. He still has numbness and tingling in hands and fingers. It was worrisome since he was an artist and paints. It is hard to paint with numbness and tingling. The numbness and tingling has stayed the same but there are periods of it getting intense from time to time, it has not subsided. He was hoping it would only last 2 or 3 days. As he was talking, he was having the tremors around ankles and feet in 2021. It was very uncomfortable and had not been able to sleep well because of it in 2021. The spasms are still the same, if anything they have worsened. No treatment received for events. The outcome of events tremor and insomnia was unknown and for remaining events was not recovered. Follow up needed, further information has been requested.
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| 46 | 2021-06-02 | weakness |
Initial discomfort subsided within 24hr (Sx pain, fever and fatigue). Tx was ibuprofen 800 and hydra...
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Initial discomfort subsided within 24hr (Sx pain, fever and fatigue). Tx was ibuprofen 800 and hydration. Lingering side effects, 1. I am an avid jogger/runner (5k and 10k and 13.1 miles). Since the vaccine was taken, I have not been able to run at the previous rate. Cannot complete a single mile without having to stop and massage legs muscles and stretch the joints. The week prior to the second dose I was running 4 miles every other day and a long distance run weekly. Also have not been able to complete my normal weight training routine. Arm, chest and back muscles shot in pain doing a previous dominate routine. example, from doing a 100 repetitions with 25pounds dumber, I cannot do 20 repetitions with 15 pounds dumber without having to stop in pain. To be able to run, take pain killers and rub muscles with pain relieving creams before a run. 2. Fatigue, without changing diet or sleep habits, raising from the bed is hard. Feel weak and struggle to get out of bed. Not mental health issues, just physical weakness.
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| 46 | 2021-06-03 | night sweats |
Night sweats; chills; Tired; This is a spontaneous report from a contactable consumer (Patient). A 4...
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Night sweats; chills; Tired; This is a spontaneous report from a contactable consumer (Patient). A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Brand: Pfizer), dose 1 via an unspecified route of administration, administered in Left Arm on 03Mar2021 12:45 PM (Batch/Lot Number: EN6205, Lot unknown: False) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included High blood pressure, High heart beat rate. Facility type vaccine: Other, Facility type vaccine other: Vaccination Center. Known allergies: No, Other medical history: High blood pressure, high heart beat rate. There were no concomitant medications. If other vaccine in four weeks: No. The patient experienced night sweats (non-serious) on 05Mar2021 02:00 am, chills (non-serious) on 05Mar2021 02:00 am, tired (non-serious) on 05Mar2021 02:00 am. Adverse event: Night sweats and chills 36 hours after taking the vaccine. Tired up to 48 hours after taking the vaccine. Adverse event country: US. If patient recovered: Recovered. If treatment ae: No. If covid prior vaccination: No. If covid tested post vaccination: No. Explicit consent: Yes. For all events, outcome was recovered on an unspecified date in 2021. No follow-up attempts are possible. No further information is expected.
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| 46 | 2021-06-03 | tingling | stiff joints, jaw pain, arms tingling, |
| 46 | 2021-06-04 | tingling |
facial tingling on the right side of face, largely cheek bone to jaw bone and only to right side of ...
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facial tingling on the right side of face, largely cheek bone to jaw bone and only to right side of face and to this day still with this sensation; This is a spontaneous report received from a contactable consumer (patient him-self). A 46-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection and Lot Number: ER8729) via an unspecified route of administration in Arm Left on 13Apr2021 (at the age of 46-year-old) as single dose for COVID-19 immunization. The patient medical history was reported as none. The patient's concomitant medications were not reported. It was reported as patient received his only dose on 13Apr2021 and about an hour after dose started facial tingling on the right side of face, largely cheek bone to jawbone and only to right side of face and to this day still with this sensation. Patient stated that some days pretty mild and some pretty severe. Not numbness but he has a feeling and has sensation and it hasn't left but states it is on his right side. He says some days are mild and other days more pronounced and it moves around face. Sometimes in cheek bone and other is jaw and always on the right side. Patient visited physician office. Lab data includes on 04May2021 he had tests and he was told that he didn't have any allergies. On 26May2021 he had MRI and he pretty much ruled out anything neurological. On an unspecified date he went through some tests a cause hasn't been identified as to why he is having symptoms. Outcome of event was not recovered.
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| 46 | 2021-06-06 | numbness, muscle twitching, tingling | tingling hands, went numb, nerve twitches hands and feet, |
| 46 | 2021-06-07 | facial paralysis, bell's palsy | Bell?s Palsy, right side of face is paralyzed, severe pain around and behind right ear. |
| 46 | 2021-06-07 | pain in extremity |
He started having chest pain and shortness of breath. Arm was sore and felt lightheaded. Blood press...
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He started having chest pain and shortness of breath. Arm was sore and felt lightheaded. Blood pressure increased. So he went to the hospital. They did chest x-rays and lab work. Monitored for about four hours for blood pressure. Gave him an IV.
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| 46 | 2021-06-08 | feeling hot |
Passed out; Warm sensation; Sweating; This is a spontaneous report from a contactable consumer, the ...
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Passed out; Warm sensation; Sweating; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old male patient received first dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on 01Apr2021 (at the age of 46-year-old) as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. Patient's medical history and concomitant medications were not reported. On 01Apr2021 (10 mins after receiving the vaccine), the patient passed out, had warm sensation and sweating. Patient was later transported to medical centre. Outcome of the events was unknown. Information on the lot/batch number has been requested.
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| 46 | 2021-06-08 | pain in extremity |
blood clot in his leg; swelling in his leg; sore arm; his muscle aches; didn't dilute it and he's re...
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blood clot in his leg; swelling in his leg; sore arm; his muscle aches; didn't dilute it and he's received 6 times over the amount; didn't dilute it and he's received 6 times over the amount; Diarrhea; real tired; his blood pressure was real high; breathing problems; This is a spontaneous report received via a Pfizer-sponsored program. A contactable consumer reported that a 46-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported) via an unspecified route of administration on 20Apr2021 (at the age of 46-year-old) as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 20Apr2021, patient experienced diarrhea, was real tired and his blood pressure was real high. It was also reported that the vaccine wasn't diluted and the patient received 6 times over the amount on 20Apr2021. On an unspecified date, patient had sore arm and his muscles ached. On Apr2021, patient had breathing problems and was treated with breathing treatments three times a day and was put on steriods and inhalers. On May2021, patient had a lab work that confirmed that he had a blood clot in his leg, which has worsened because he has some swelling in his leg, the same leg that they found the blood clot in. The patient was hospitalized for the event blood clot in his leg and was given blood thinners. The patient underwent lab tests and procedures which included CAT scan of head and lungs both with unknown results on May2021. Outcome of the events blood clot in his leg, swelling in his leg and breathing problems was not recovered while outcome of all other events was unknown. Information on the lot/batch number has been requested.
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| 46 | 2021-06-09 | weakness |
fever; chills; vomiting; weakness; headache; cough; trace- pleural effusion; who received the entire...
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fever; chills; vomiting; weakness; headache; cough; trace- pleural effusion; who received the entire vial of the undiluted Pfizer COVID vaccine; received the entire vial of the undiluted Pfizer COVID vaccine/The entire vial was administered all 6 doses in the right deltoid; This is a spontaneous report from a contactable nurse and a physician. The nurse reported similar events for two patients. This is one of the two reports. Only this case is serious. A 46-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 46 years old, administered in right deltoid on 12May2021 (Lot Number: EW0168; Expiration Date: Aug2021) at single dose for COVID-19 immunization. Medical history included ongoing CRD on hemodialysis since 25Sep2017, ongoing Polycystic kidney, ongoing HTN, ongoing Brain aneurysm, ongoing GERD, ongoing Seizure disorder; Fever, nausea, vomiting, sepsis, Secondary hyperparathyroidism. Family history included Polycystic kidney disease- brother/father/uncles. Concomitant medications included ongoing allopurinol, ongoing paracetamol (TYLENOL), ongoing amlodipine, ongoing cholecalciferol, hydralazine, metoprolol, vitamins nos (MVI), phenytoin. Historical Vaccine included first dose of BNT162B2 on 21Apr2021 (Lot number ER8736, Expiration date Jul2021) at the age of 46 years old, administered in right deltoid for COVID-19 immunization. The nurse reported a medication error for two patients who received the entire vial of the undiluted Pfizer COVID vaccine on 12May2021. The entire vial was administered all 6 doses in the right deltoid. The reporter did not provide specific signs and symptoms. They were in their care after the vaccine was given for an hour and was sent home. They were instructed for any signs and symptoms to report to ER immediately. The patient also experienced fever/chills, vomiting, weakness, headache and cough, all on 12May2021 which were caused emergency room visit and hospitalization from 13May2021 to 15May2021 with treatment unknown. Lab data included CXR on 13May2021 with result: trace- pleural effusion. The outcome of the events were unknown. Follow-up (25May2021): new information received from a contactable physician included: new reporter-physician added, medical history and concomitant medications added, lab data added, vaccination on 12May2021 is updated as second dose and Historical Vaccine with first dose of BNT162B2 added, new events "fever/chills, vomiting, weakness, headache and cough, trace- pleural effusion" added and case upgrade to serious. No follow-up attempts are needed. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event and the suspect drug cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate. ,Linked Report(s) : US-PFIZER INC-2021540031 Same reporter/product, similar events, different patient
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| 47 | 2021-01-03 | numbness | NUMBNESS TO BOTH ARMS AND LEGS |
| 47 | 2021-01-04 | numbness, facial pain |
Developed right sided facial numbness; numbness of right side of anterior tongue; numbness progresse...
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Developed right sided facial numbness; numbness of right side of anterior tongue; numbness progressed to some facial pain as well; This is a spontaneous report from a contactable Other Health Professional (patient). A 47-year-old male received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EJ1685, intramuscular in the right arm, first dose given on 23Dec2020 12:30 at a single dose for COVID vaccination. Medical history included asthma, seasonal allergic rhinitis and Bell's Palsy affecting that side of the face. Concomitant medication included loratadine, pseudoephedrine sulfate (CLARITIN-D) and montelukast sodium (SINGULAIR). The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. He was not diagnosed with COVID-19 prior to and post vaccination. The patient previously took and had allergies to Keflex, Vicodin and Motrin. It was reported that the patient developed right-sided facial numbness and numbness of right side of anterior tongue. These occurred within 10- 15 minutes of vaccine administration on 23Dec2020 at 12:45 PM. It was mentioned that the patient has history of Bell's Palsy that was affecting that side of the face. The patient had numbness progressed to some facial pain as well. Symptoms lasted for 6 days and slowly abated with prednisone treatment which was given at 20 mg BID (twice a day) x 5 days. The events were reported as non-serious. The outcome of the events patient developed right-sided facial numbness and numbness of right side of anterior tongue and numbness progressed to some facial pain as well was recovering.
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| 47 | 2021-01-06 | tingling |
Monday morning I woke up with itchy red hives in several parts of my body, Tuesday morning since the...
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Monday morning I woke up with itchy red hives in several parts of my body, Tuesday morning since the symptoms were not any better (legs, torso) I decided to go to the walk in clinic at work and they suggested me to take some OTC Benadryl and it did work the same day and the rest of the day. The next day around lunch time the hives came back again I had a very red and tingling area around my neck and in my head. I returned to the walk in clinic and they gave me shot of Benadryl and prednisone and another drug I do not remember.
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| 47 | 2021-01-06 | throat numbness |
Numbness noted in tongue and back of mouth/throat starting morning after injection. No other associa...
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Numbness noted in tongue and back of mouth/throat starting morning after injection. No other associated symptoms noted
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| 47 | 2021-01-07 | pain in extremity |
sore arm, swelling/"knot" at injection stie; this has resolved. But still experiencing pain/limited ...
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sore arm, swelling/"knot" at injection stie; this has resolved. But still experiencing pain/limited range of motion 3 weeks post vaccine Narrative: pain and limited ROM of arm; she is seeking care through her pcp; xray of her arm has been ordered by her pcp
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| 47 | 2021-01-08 | seizure, cold sweat |
Dizziness, Seizures, Syncope, Bradycardia, cold, clammy Narrative: 10 mins after administration, Emp...
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Dizziness, Seizures, Syncope, Bradycardia, cold, clammy Narrative: 10 mins after administration, Employee began expressing lightheadedness, Employee assessed, employee was cold and clammy. Employee then began to have a seizure which last approx 30 sec. Vital signs assessed BP 110/80 HR 87 then dropped to 50 which is unusual for employee. o2 sat 94% on room. Employee regained consciousness and was able to state name, time and place. Reported no previous history of seizures. Employee handed off to ER staff for further eval.
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| 47 | 2021-01-10 | muscle spasms |
fever >100 , body aches/whole body muscle spasms, chills, nausea (no vomiting), headaches, physical ...
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fever >100 , body aches/whole body muscle spasms, chills, nausea (no vomiting), headaches, physical exhaustion, all symptoms resolved approx 1.5 days of vaccine administered, symptoms began approx 12 after vaccine received.
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| 47 | 2021-01-10 | pain in extremity |
1. Onset roughly 12 hours after injection lasting until approximately 32 hours after injection: feve...
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1. Onset roughly 12 hours after injection lasting until approximately 32 hours after injection: fever, chills, body aches, nausea, sore left arm. Treated with 600 mg Ibuprofen every four hours. Fever would break and then come back. 2. Onset roughly 51 hours after injection lasting until approximately 55 hours after injection: fever, chills. Treated with 600 mg Ibuprofen. No symptoms since.
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| 47 | 2021-01-11 | pain in extremity |
Very minor light headedness the day after injection; typical sore arm; This is a spontaneous report ...
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Very minor light headedness the day after injection; typical sore arm; This is a spontaneous report from a contactable other HCP (patient). A 47-year-old male patient received the first dose of BNT162B2 (Lot number: EL1284), via an unspecified route of administration on Jan2021 09:30 at single dose in the left arm for COVID-19 immunization. Medical history included high BP and Pre-diabetic, both from unknown dates. The patient's concomitant medications were not reported. The patient previously took codeine and experienced allergies. The patient experienced very minor light headedness the day after injection on Jan2021. It lasted throughout the day. Also reported typical sore arm on Jan2021. Neither of which required any medical attention. The patient did not receive any treatment for the events. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovered on an unspecified date. No follow-up attempts are possible. No further information is expected.
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| 47 | 2021-01-12 | numbness, bell's palsy |
Reported facial and lip numbness x 3 days following covid vaccination (Bells Palsy) . By 5pm it had ...
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Reported facial and lip numbness x 3 days following covid vaccination (Bells Palsy) . By 5pm it had creep to the face, right cheek was not responding fully. Described the numbness like having a Novocain at the dentist. Symptoms lasted 3 days
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| 47 | 2021-01-14 | cold sweat |
Pulse dropped to 30. Low pressure too. Brachycardia. Lost consciousness. Did not seem to be Vasovag...
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Pulse dropped to 30. Low pressure too. Brachycardia. Lost consciousness. Did not seem to be Vasovagal. Saline IV. Blurred vision. Very. Strange. Girl friend said I seemed catatonic for about 5-10 seconds. Cold sweat. Dizziness. Immediate Symptoms lasted about an hour. Injection site very sore 10 hours later. Body pains.
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| 47 | 2021-01-14 | muscle spasms |
2 days after vaccine, left neck spasms and pain. Now developed sternoclavicular synovitis on the lef...
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2 days after vaccine, left neck spasms and pain. Now developed sternoclavicular synovitis on the left side
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| 47 | 2021-01-14 | muscle twitching, flushing, pain in extremity |
1/13/21 0740 Received second dose of COVID-19 vaccine, which was scheduled for that morning. Did not...
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1/13/21 0740 Received second dose of COVID-19 vaccine, which was scheduled for that morning. Did not experience anaphylaxis or other symptoms of vaccine injury. I took 1gram of Tylenol PO when I got back to my motel by 0830. By 0924 I noted that my left deltoid (injection site) and arm were very sore/achy. I fell asleep until 1740. I noted that I was experiencing more body aches at this time (joint and muscle, especially in my bilateral shoulders, lower back, knees and pelvis). Calf muscles were quite sore. I made pasta with red sauce and made a pot of blueberry tea, ate and went back to bed. 2327 I woke again with weird fever dreams and my right bicep was intermittently twitching. I think I was starting to run a low grade fever at this time (my ears felt hot, and my stomach was queasy but was not nauseous), no diaphoresis, shortness of breath or airway constriction. I remained awake until 0200, 1/14/21. By 0400 I was experiencing mild chills, face was flushed, headache on the right, with pressure behind my right eye, parietal and occipital areas of my skull. The pain extended into the right muscles of my neck (trapezius, levator scapulae and sternocleidomastoid muscles). Bilateral upper arm muscles and joints were 5:10 pain. I was also experiencing mild photophobia, but not migraine related, and a mild non-productive cough and pressure behind my facial and ethmoid sinuses with scant viscous secretions at the back of my throat. 0433 I forced myself to get out of bed and head to the bathroom. My temp was 101. I took a very hot shower and am back in bed. Experiencing a lot of malaise and lethargy. 1/15/21 0830 temp is currently 99.1, headache is present, 3:10. Joint aches have mostly subsided. Injection site is warm and tender, but no erythema is present.
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| 47 | 2021-01-14 | seizure |
Day of the vaccination, patient went home and developed a bilateral nosebleed and had a seizure. Pat...
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Day of the vaccination, patient went home and developed a bilateral nosebleed and had a seizure. Patient continues to feel poorly as of 1/15/2021 but has returned part time to work.
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| 47 | 2021-01-18 | tingling | New Sporadic Tingling sensation to the upper spine. |
| 47 | 2021-01-20 | pain in extremity |
Tennis ball size swelling of lymph notes in Right armpit. Discovered 36 hours after shot. Only oth...
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Tennis ball size swelling of lymph notes in Right armpit. Discovered 36 hours after shot. Only other symptom is pain in right arm that required OTC ibuprofen.
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| 47 | 2021-01-20 | pain in extremity |
nausea; vomiting; Mild headache; arm was hurting/Left arm soreness; This is a spontaneous report fro...
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nausea; vomiting; Mild headache; arm was hurting/Left arm soreness; This is a spontaneous report from a contactable physician reporting for himself. A 47-years-old male patient received the second dose of bnt162b2 (BNT162B2; Lot # EJ1686) vaccine , intramuscular in the left deltoid on 07Jan2021 11:00 at single dose for Covid-19 immunisation . The patient medical history was not reported. There were no concomitant medications. Previously on 17Dec2020 the patient received the first dose of BNT162B2 vaccine. The patient experienced nausea and vomiting on 10Jan2021 23:59 with outcome of recovered , mild headache on 07Jan2021 20:30 with outcome of recovered , arm was hurting/left arm soreness on 07Jan2021 20:30 with outcome of recovered. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: negative on 20Nov2020. Nausea and vomiting were considered Important Medical Events.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the events nausea and vomiting cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 47 | 2021-01-21 | pain in extremity |
About 4 am the night after the vaccination, I developed significant left arm pain. Hurt; throbbed ...
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About 4 am the night after the vaccination, I developed significant left arm pain. Hurt; throbbed and didn't want to use it. Went to work but about 7:00 am- I noticed my right arm began to work as well - almost in the the same severity. Spell- lose consciousness alost- had bad headache; - it abated and it happened again - almost lost consciousness. It left. And it happened again a third time and went to a stretcher - nurse took my BP 220/110 - blood pressure - very high for me and laid on the stretcher and had nurses hook me up ot monitors; No change on cardiogram and my oxygen saturation level never altered and never dropped; My BL remained elevated - significantly. 180/90 before I went home. Continued to check my BP when I went home - queasy; nauseated - upset stomach and then fever the following day - remained for 4-5 days. Fever was one day and got 100.5 and then was gone after that day. BP continued to check regularly through next few days - it did improve a bit but was still elevated - 180/150 (systolic) and 110/95 (Diastolic) - Slowly got back to normal by day 7 after vaccination. Went to work the 30th the day before New Year's Eve, finally and had dizziness never got quite as severe - 50% but left arm pain very very painful - almost numb; right arm hurt some, too. Blood 190/110 .Oxygen Saturation remained good. Arm pain very bad - ordered EKG - was normal Admitted my self to ER - Had a full work up - repeated EKG - negative; two sets of troponins - negative; chest x-ray - nothing - BMP - elevation in my creatine which I've never had before. CBC - normal; They treated me with fluid hydration; Tylenol; fentanyl and hours later I felt a bit better. Things calmed down and I was released. BP remained elevated for next two days. I got better after two days _ enough to work - but still would get a little disequilibrium not enough to pass out but just like an odd feeling and then it would go away after a few seconds. And that is only recently disappeared - within the last week or so. I feel better now but my BP remains elevated - 160/140 (systolic) over 105/95 (dystolic) - that's al new for me. I have declined the second vaccination. Have sort of recovered but it did come back after time and so it may come back again - don't know. I may have been exposed to COVID the week before my vaccination. About 4 days after the severe symptoms that lead to my leading to take off work; I took test for COVID - PCR at CVS (returned positive) and COVID test PCR and rapid antigen (returned negative) at Public Health -
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| 47 | 2021-01-24 | migraine |
Approximately 48 hrs after my second Pfizer vaccination for covid I experienced chills, migraine, le...
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Approximately 48 hrs after my second Pfizer vaccination for covid I experienced chills, migraine, lethargy, loss of appetite, and general digestive discomfort. Treated with plenty of fluids, naproxen, and rest. Experienced mild fever but never > 100 degrees that I know of.
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| 47 | 2021-01-25 | tremor |
Uncontrollable shivering shaking almost like a seizure type. Severe headache, pain muscles, close th...
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Uncontrollable shivering shaking almost like a seizure type. Severe headache, pain muscles, close throat dry throat. Tiredness fatigue.
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| 47 | 2021-01-26 | flushing, feeling hot | Systemic: Headache-Medium, Systemic: Warm, flush feeling at forehead; symptoms lasted 1 day |
| 47 | 2021-01-26 | numbness, tingling |
Pfizer-BioNTech Covid 19 Vaccine Description 1.26.2021: It first started with swelling hands then ...
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Pfizer-BioNTech Covid 19 Vaccine Description 1.26.2021: It first started with swelling hands then tingling in bilateral fingers and hands. That progressed to tingling in feet and toes. The nerves coming into my arm pits were very painful and I couldn't put my arms against my body. Petechia rash on my torso. Numb left lower lip and jaw area, numb right shoulder, numb shins and calfs. when the numb lip began my PCP had me go to the ED for evaluation. All blood work and Electrolytes came back normal. All this lasted over a week and the petechia spots are still on my torso, but seem to be going away.
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| 47 | 2021-01-27 | tingling, feeling hot |
I experienced headaches, severe abdominal pain, change in bowel movements, ribs felt like they were ...
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I experienced headaches, severe abdominal pain, change in bowel movements, ribs felt like they were being ripped apart, tired/fatigue, blurry vision, dizziness, my body felt hot from the inside out, tingling sensation in feet and hands.
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| 47 | 2021-01-31 | night sweats | soreness, fatigue, congestion, night sweats, itchy, rash, difficulty breathing |
| 47 | 2021-01-31 | tingling | tingling to face, redness to face, headache, throat swelling |
| 47 | 2021-02-01 | hot flush, flushing |
0825 flushed, nausea , slightly SOB, O2 sat 96%, RR24 HR 77 BP 137/97. Pepcid 40mg, Benadryl 50mg...
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0825 flushed, nausea , slightly SOB, O2 sat 96%, RR24 HR 77 BP 137/97. Pepcid 40mg, Benadryl 50mg 0830 Dizzy, flushed, SOB 0835 Dizzy, not flushed feeling, slightly SOB. O2 sat 95% 0840 Throat scratchy - slight difficulty to swallow O2 sat 93-94% HR 90 RR 28 0850 Epi pen injection, Throat tight and scratchy, hard to catch breath after coughing 911 called 0900 Ambulance transported to ER 0909 Ambulance arrived to ER still somewhat SOB and scratchy throat and nauseated, Dizziness improved. No stridor or wheezing, no hives or itching, no swelling of tongue or lips or facial swelling Received IV Benadryl, IV Decadron, IV Pepcid and albuterol nebulizer treatment and observed for an extended amount of time. SOB cleared, throat issue resolved and was discharged with just a slight residual tiny scratchy throat. He was discharged on Benadryl every 6hours until symptoms are completely resolved and Prednisone for 3 days starting on 1/26 if any residual symptoms are felt. Also given Albuterol inhaler if develop any recurrent SOB. Released home at 1413 on 1/25. Follow up on 1/27 and he stated he had fully recovered
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| 47 | 2021-02-01 | tenderness |
Staff experienced left shoulder tenderness and general malaise after vaccination. The malaise was de...
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Staff experienced left shoulder tenderness and general malaise after vaccination. The malaise was determined to be enough for the staff to miss work to stay home and rest.
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| 47 | 2021-02-02 | pain in extremity |
After the vaccine, within about an hour after, I started feeling a headache, diarrhea, and extreme f...
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After the vaccine, within about an hour after, I started feeling a headache, diarrhea, and extreme fatigue. The next day I still had a headache, fatigue and arm soreness. On the 31st, the symptoms kinda went away. I did notice some SOB when walking. I did see my Pulmonologists and was prescribed a medicine.
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| 47 | 2021-02-03 | feeling cold, numbness |
Muscle aches, fever of 102, got/cold feeling, loss of appetite, dry heaving, lethargic and sleepy, n...
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Muscle aches, fever of 102, got/cold feeling, loss of appetite, dry heaving, lethargic and sleepy, numnous in hands
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| 47 | 2021-02-03 | pain in extremity |
Upper arm pain, mild; muscular discomfort, mild; This is a spontaneous report from a contactable con...
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Upper arm pain, mild; muscular discomfort, mild; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EL3247) solution for injection intramuscular in the left arm on 20Jan2021 at 13:45 (at the age of 47-years-old) as a single dose for COVID-19 vaccination. There was no medical history. There were no concomitant medications. There were no allergies to medications, food, or other products. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 21Jan2021 at 13:45, the patient experienced upper arm pain, mild with associated muscular discomfort, mild. No treatment was provided for the events upper arm pain and muscular discomfort. The outcome of the events upper arm pain and muscular discomfort was recovering. Since the vaccination, the patient has not been tested for COVID-19.
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| 47 | 2021-02-06 | weakness |
I 'had Covid' beginning Saturday before Thanksgiving. During that period, I had two tests, both fro...
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I 'had Covid' beginning Saturday before Thanksgiving. During that period, I had two tests, both from facility, and both tests came back negative. Symptoms included fever 102-103 for 12 days. No appetite (didn't eat for that duration). Headache. Excessive sweating. Extreme shallow breath. Hyperventilation. Body ache. No loss of smell or taste. No nausea. No mucus response. Since that time, I have experienced extreme fatigue, weakness, shortness of breath, headache. After the first shot, those three symptoms increased. With the second shot, I had fever 99.5-101 from Tuesday though Saturday. Nausea, headache, body ache, weakness, shortness of breath. It felt 85% similar in symptom and intensity as when I 'had Covid'. The greatest difference is the nausea. When I 'had Covid' there was no nausea and I did not throw up. This time, I had persistent nausea and threw up multiple times in the first three days.
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| 47 | 2021-02-07 | numbness, tingling, cold extremities |
At time of the vaccine: I experienced a tingling/numbing sensation down my left arm into my left han...
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At time of the vaccine: I experienced a tingling/numbing sensation down my left arm into my left hand and fingers. Approximately 18 hours after the vaccine: I experienced chills, elevated temperature (99 to 100 degrees F), headaches, fatigue. Approximately 42 hours after the vaccine: the chills, elevated temp, headaches, and fatigue were gone, but I had a armpit aching on the left side. The armpit ache faded over the next 24 hours. Today is 7 days post vaccine and I still have periodic tingling/numbing/cool sensation on the pinky and ring fingers on my left hand.
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| 47 | 2021-02-07 | numbness, tingling |
After injection, left side finger tips and face tingled. Finger tips resolved, face felt numb afterw...
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After injection, left side finger tips and face tingled. Finger tips resolved, face felt numb afterwards including head and neck. Feels like patient had dental work and the numbing is wearing off.; After face felt numb afterwards including head and neck. Feels like patient had dental work and the numbing is wearing off.; This is a spontaneous report from a contactable consumer reporting for himself. A 47-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number EL3249, via an unspecified route of administration on 22Jan2021 10:00 (at the age of 47-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history included acromegaly (surgery done to remove tumor) from an unknown date and unknown. The patient's concomitant medications were not reported. The patient previously took doxycycline and experienced drug allergy. The facility where the most recent COVID-19 vaccine was administered was at a hospital.On 22Jan2021 10:00AM, the patient experienced after injection, left side finger tips and face tingled. Finger tips re-solved, face felt numb afterwards including head and neck. Feels like patient had dental work and the numbing is wearing off. The events after injection, left side finger tips and face tingled. Finger tips re-solved, face felt numb afterwards including head and neck. Feels like patient had dental work and the numbing is wearing off were reported as non-serious and did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. No treatment was received for the events. The clinical outcomes of the "after injection, left side finger tips and face tingled. Finger tips resolved, face felt numb afterwards including head and neck. Feels like patient had dental work and the numbing is wearing off" was not recovered. Prior to the vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19.
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| 47 | 2021-02-09 | pain in extremity |
Shortness of breath; palpitations/increased heart rate; palpitations/increased heart rate; Immediate...
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Shortness of breath; palpitations/increased heart rate; palpitations/increased heart rate; Immediate left arm/chest pain; Immediate left arm/chest pain; fatigue; body aches; This is a spontaneous report from a contactable physician. A 47-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3246), via intramuscular, on 18Jan2021 at single dose on the left arm for COVID-19 immunisation, administered at Hospital. The patient did not have a relevant medical history. No known allergies. No relevant concomitant medications were provided. No other vaccine was received in four weeks. The patient developed immediate left arm/chest pain, and fatigue/body aches. On 23Jan2021 (5 days later), he developed shortness of breath and palpitations/increased heart rate. Post-vaccination COVID test was not performed. The patient was not treated for the events. The patient was recovering from the events.
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| 47 | 2021-02-11 | pain in extremity |
Local arm soreness and generalized muscle aches. Approximately 6/10. Took Tylenol, resolved after ab...
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Local arm soreness and generalized muscle aches. Approximately 6/10. Took Tylenol, resolved after about 30 hours.
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| 47 | 2021-02-14 | migraine |
Migraine Headaches; chills; body aches; sore arm; This is a spontaneous report received from a conta...
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Migraine Headaches; chills; body aches; sore arm; This is a spontaneous report received from a contactable other healthcare professional (who is also the patient). A 47-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261, expiry date: unknown), intramuscular in the left arm, on 26Jan2021 14:00, at single dose, for COVID-19 immunization, at the hospital. Medical history included migraine and diabetes mellitus (diabetic). The patient has no allergies to medications, food or other products. Concomitant medication included metformin hydrochloride, sitagliptin phosphate monohydrate (JANUMET). The patient did not receive any other vaccines within 4 weeks prior to BNT162B2 vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-10 post vaccination. The patient experienced migraine headaches, chills, body aches and sore arm on 26Jan2021 at 14:00. No treatment was given for the events. The outcome of the events was unknown. The events were assessed as non-serious.
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| 47 | 2021-02-15 | pain in extremity |
Had daily headaches after first dose of vaccine. For 3 weeks. Decided to skip the second dose becaus...
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Had daily headaches after first dose of vaccine. For 3 weeks. Decided to skip the second dose because of that. Then had leg pain after nearly a month of the vaccine. Thought it was muscle pain but landed up in ER with shortness of breath and was diagnosed with DVT and large PE.
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| 47 | 2021-02-17 | weakness |
onset of dizziness and fatigue 24 hours after vaccine (1/30/2021). 48 hours after vaccine (1/31/20...
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onset of dizziness and fatigue 24 hours after vaccine (1/30/2021). 48 hours after vaccine (1/31/2021), developed cough and low grade fever. Symptoms continued to progress with continued cough, fatigue, and generalized weakness with shortness of breath. Had O2 sat of 88% with activity on 2/9/2021 and went to emergency department and was diagnosed with pneumonia. Treatment started for community acquired pneumonia with Amoxicillin and Azithromycin. Patient discharge home from emergency department
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| 47 | 2021-02-17 | migraine |
I was dizzy all along and almost fainted; I was dizzy all along and almost fainted; migraine; This i...
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I was dizzy all along and almost fainted; I was dizzy all along and almost fainted; migraine; This is a spontaneous report from a contactable consumer (patient). This 47-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on 20Jan2021 for COVID-19 immunization. Medical history included sleep apnea; high blood pressure; high cholesterol; borderline diabetes. Concomitant medications included losartan; alirocumab (PRALUENT, injection) on 20Jan2021. Since 23Jan2021, patient was dizzy all along and almost fainted and was still having symptoms of mild migraine and he don't know like some light sensitivity. Doctor believed it was from vaccine. Patient was wondering how long was this going to be last as he had second shot coming out. He didn't think it was an adverse reaction and he thought he should get the second shot. But this was continuing to me and it had already been two weeks and patient still having symptoms of mild migraine. Patient was worried about taking the second shot as a result. He had never had a migraine before and was told it was probably from the vaccine and that was not something he wanted to hear. Patient wanted to know if this was normal to still be having this side effect for this long. Patient was taking acetaminophen (for migraine), it was not a TYLENOL, it was from a different brand. Patient did liver and cholesterol test and blood test in Jan2021 at Cardiologist and they came back fine, nothing was found there. The outcome of event migraine was not resolved. The outcome of rest events was unknown. Information on the lot/batch number has been requested.
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| 47 | 2021-02-18 | weakness |
Within a half hour, I felt dizzy and light headed. in 45 minutes - I could barely stay awake. I had ...
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Within a half hour, I felt dizzy and light headed. in 45 minutes - I could barely stay awake. I had to stop driving. Within two hours, I had a bad headache. I became slightly agitated that day. The headache lasted throughout the day - I took Ibuprofen but that didn't help much. Sunday, the headache was still there. It wasn't a migraine; but intense. I was agitated. My agitation level grew and my irritability grew and the headache I had the whole day. Sunday evening about 7 pm the agitation and irritability got very intense - I was having impulse control issues with it. I don't have anger issues but I wanted to yell at TV or throw my phone. From 8- midnight, I was lethargic and fatigued - I didn't have the energy to roll over;: had extreme anxiety I was sweating and having weird thoughts like harming my animals and harming myself; my mind was racing and then I would get really depressed. Until about midnight, I have had past struggles with anxiety and depression - there had been a past feeling like this - but it was really extreme - it was worse night of my life. Lasted four hours, and finally I slept for about one hour. I remember thinking, I finally can take a breath. My racing thoughts were gone and sweating was gone. The irritability had subsided enough that I could try to gain control of my thoughts again. I had really bad nightmares the rest of that night; I was confused _ I didn't know where I was - confused about that - occurred about three different times until I got up at 5:30 am for work. To summarize, for the next week, I had moments of anxiety and depression. I had mental fog. I played pro football - and I had post concussion syndrome. It was very identifiable to what I had had. So this was occurring in moments - forgetful; depressed; and random moments of anxiety - like I was going to go play football again. 7-10 days - it got a little better each day. Ten days it took to subside. I still exercised and taking extra fluids to get back to my normal. Exercised help. No fever occurred. With COVID - I had had a sense of anxiety and depression and some mental fog when I had COVID I didn't have it to this extreme. Did not get the second dose.
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| 47 | 2021-02-23 | pain in extremity |
Vaccine given 2/17/2021. Client developed soreness in arm and shoulder area and chills post vaccin...
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Vaccine given 2/17/2021. Client developed soreness in arm and shoulder area and chills post vaccine, joint achiness on day 2 post vaccine. On 2/21, client developed lower back and flank pain bilaterally which progressively got worse and continues yet on 2/24. Client rates pain a 6 or 7. Pain is constant. Pain will decrease to a 2 or 3 following Aleve. Denies blood in urine, urgency, burning with urination or difficulty starting urine stream. States bowel movements have been normal. States discomfort is not like a pulled muscle sensation. Has had temperature in the 99 degree range. Client started Potassium supplement on 2/22 thinking it may help but has had no relief. Pain continues as of time of report.
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| 47 | 2021-03-02 | weakness |
Patient received 1st dose of his Covid vaccine; after~10 min, during observation period, he was not...
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Patient received 1st dose of his Covid vaccine; after~10 min, during observation period, he was noticed to become pale ,diaphoretic and with decreased level of responsiveness; was put on the stretcher. Physician who was monitoring the vaccination area reported: "BP 110/64 HR 76 Sat 95% Patient was feeling better upon being placed supine and was verbalizing as well. Denied chest pain and shortness of breath. Just felt dizzy and weak." Patient was taken to ER; CBC,CMP,ECG- all normal and he was discharged after 2 hrs of observation with diagnosis of Vasovagal Syncope. Today, patient is well and went to work as per his spouse. Patient has history of similar syncope or near syncope events in the past during stressful situations, like seen blood .
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| 47 | 2021-03-10 | pain in extremity |
Sore arm; This is a spontaneous report from a contactable consumer (patient). A 47-years-old male pa...
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Sore arm; This is a spontaneous report from a contactable consumer (patient). A 47-years-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot no: EL3302, via an unspecified route of administration in left arm on 05Feb2021 10:15 at a single dose for covid-19 immunization in a military base at age 47 years old. The patient's medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced sore arm on 05Feb2021 10:15. The event was reported as non-serious. No treatment was received from the adverse event. The patient recovered from the event on an unspecified date in Feb2021. No follow-up attempts are possible. No further information is expected.
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| 47 | 2021-03-12 | weakness |
I have had multiple issues, back pain, chills, uncontrollably fall asleep, feel feverish with no fev...
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I have had multiple issues, back pain, chills, uncontrollably fall asleep, feel feverish with no fever, exhaustion, joint pain, weakness.
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| 47 | 2021-03-16 | bell's palsy, slurring, facial paralysis |
Swollen face, tongue feels fat, headache behind R ear, facial dropping, slurring words, eye doesn't...
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Swollen face, tongue feels fat, headache behind R ear, facial dropping, slurring words, eye doesn't close all the way. Started Sunday night to the morning went to ER. Did blood test for Lymes. Diagnosed with Right sided BELLS PALSY Gave prednisone and Valtrex in ER and discharged on those meds too.
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| 47 | 2021-03-17 | numbness, bell's palsy, facial paralysis |
Patient presented tot he hospital Emergency Department with right side facial numbness and drooping....
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Patient presented tot he hospital Emergency Department with right side facial numbness and drooping. Patient was initially screened as a stroke patient but it was ultimately diagnosed as Bell's Palsy. Patient was treated and discharged home.
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| 47 | 2021-03-18 | feeling hot |
The pt received the vaccine and after approximately 5-10 minutes while waiting, informed the staff h...
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The pt received the vaccine and after approximately 5-10 minutes while waiting, informed the staff he was experiencing some anxiety and added he gets this when he only drinks coffee and not having eaten anything. His vital signs were done by the nurse and the PA spoke with him, too. He was given 6 8oz water bottles, a few pkgs of graham crackers and a banana while he waited in the rear of the pod. When he mentioned "chest" breathing the PA decided he should be brought to the E.D. The pt was going to walk but the staff requested he be wheeled down. He went to the E.D> with an RN and the Pod Mgr. ED: 47 yo m no pmhx p/w lightheadedness after receiving his covid vaccine. AFVSS, well-appearing, nad. Feeling better after eating, no cp or sob. Do not suspect acs. No signs of allergic reaction. Possible vasovagal vs anxiety related to vaccine. Reassurance provided, Plan for dc
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| 47 | 2021-03-18 | flushing | Mild to moderate headaches, chills and flush feeling Ibuprofen 600 mg @ 2 times/day |
| 47 | 2021-03-19 | tremor |
Patient felt like something was in his throat, tongue felt thick, dizziness/lightheadness, and tremo...
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Patient felt like something was in his throat, tongue felt thick, dizziness/lightheadness, and tremors
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| 47 | 2021-03-21 | flushing, cold sweat |
Pt appeared dizzy, cold and clammy, pale, and flushed. Paramedics accessed pt, found out he was hypo...
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Pt appeared dizzy, cold and clammy, pale, and flushed. Paramedics accessed pt, found out he was hypotensive. MD on site examined pt and called management. Pt was transported to Hospital via ambulance, accompanied by wife. Pt was alert and oriented x3, EKG done on sinus rhythm .
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| 47 | 2021-03-21 | pain in extremity, feeling hot |
Notes: APRN (Nurse Practitioner), Cosigned by: MD at 3/19/2021 9:22 AM, COVID VACCINE CLINIC 3/18/20...
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Notes: APRN (Nurse Practitioner), Cosigned by: MD at 3/19/2021 9:22 AM, COVID VACCINE CLINIC 3/18/2021 Patient/Date: 3/18/2021 Subjective: a 47 y.o. male who was seen at SVH COVID Vaccine Clinic today for his first dose of the COVID Pt is a 47 y.o. male who was seen at COVID Vaccine Clinic for his first does of COVID 19 vaccination. He was given the Pfizer vaccination in the left deltoid muscle. During his 15 minute waiting period after the injection, the patient began to experience lightheadedness and dizziness. He denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and he was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to abdominal pain, blood pressure abnormality , chest pain, collapse, drooling, hypotension, increased swelling, rapid progression of symptoms, respiratory distress, skin changes, tongue swelling and vomiting. Pt received shot and complained of being hot and sweaty. He was laid on the floor in injection room 5, with his feet elevated, some water was given and once pt was feeling better he was transferred to the ER bay for observation. He refused a wheelchair and walked to the bay with help. After sitting for awhile we cooled down and he was allowed to leave. ALLERGY REVIEW OF SYSTEMS: Patient complains of dizziness, and hot and sweaty: CONT negative, HENT negative, Eyes negative, Respiratory negative, Skin negative, GI negative, Musculo negative, Previous Reactions: None, Objective: Vitals - There were no vitals filed for this visit. Physical Exam - Constitutional: Appearance - He is well-developed. HENT: Head -Normocephalic and atraumatic. Right Ear- External ear normal. Left Ear: External ear normal. Nose - Nose normal. Eyes - Conjunctiva/sclera: Conjunctivae normal. Pupils - Pupils are equal, round, and reactive to light. Cardiovascular: Rate and Rhythm - Normal rate and regular rhythm. Heart sounds: Normal heart sounds. Pulmonary: Effort - Pulmonary effort is normal. Breath sounds: Normal breath sounds. Musculoskeletal: General -Normal range of motion. Cervical backN -normal range of motion and neck supple. Skin: Coloration: Skin is pale. Neurological: Mental Status - He is alert and oriented to person, place, and time. Assessment/Plan: Treatment include - water and snacks. Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Local reaction (arm pain, bleeding/bruising, mechanical irritation, localized rash). Pt was released at 3:26, he was accompanied by his wife. APRN Electronically Signed 3/18/2021 3:19 PM
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| 47 | 2021-03-22 | cold sweat, seizure |
Patient stated prior to vaccine he has a history of fainting after vaccination. About 1 minute after...
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Patient stated prior to vaccine he has a history of fainting after vaccination. About 1 minute after vaccination he became pale, clammy, and lightheaded. Spoke with patient while someone else retrieved an ice pack and water. About 2 minutes after vaccination patient became unconscious and upper body had seizure like activity. Patient was moved to the floor immediately regained consciousness. Event lasted approximately 15-20 seconds. After regaining consciousness, stated he felt better. Remained on the floor for about 5 minutes, EMS was called as precaution. EMS stated vital signs and blood sugar were stable. Patient refused transport to hospital. Instructed to follow up with PCP.
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| 47 | 2021-03-23 | numbness |
Patient reports receiving first dose of COVID-19 from Hospital (was not given vaccine card as their ...
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Patient reports receiving first dose of COVID-19 from Hospital (was not given vaccine card as their policy is to wait until after second dose). The day after vaccination, patient was complaining of fatigue with subjective fevers and rigors with associated headache and neck stiffness and on the day of presentation he complained of increased fatigue and general malaise for which he left work early and was ultimately found poorly responsive in his private vehicle with concern for possible seizure activity. He was brought to ER by ambulance. He reported numbness in hands and legs, rigidity, and an episode of urinary incontinence. He was started on empiric antibiotics for possible CNS infection, lumbar puncture completed. Found to have acellular CSF and antibiotics were discontinued. Patient remains in hospital at this time with course complicated by post-LP headache.
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| 47 | 2021-03-23 | numbness |
Numbness of right side of face. No treatment sought at this time. Still some numbness 5 hours after ...
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Numbness of right side of face. No treatment sought at this time. Still some numbness 5 hours after shot.
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| 47 | 2021-03-25 | inability to speak, facial paralysis |
47 year old Gynecologist with PMH of severe MDD, GERD, asthma, referred to the ED by his PCP, after ...
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47 year old Gynecologist with PMH of severe MDD, GERD, asthma, referred to the ED by his PCP, after 5 days of gait instability, and about 4 weeks of altered mental status, confusion, short term memory deficits and malaise. ADEM suspected and extensive infectious, inflammatory and neoplastic workup was initiated. CT brain - reported NAD MRI brain consistent with Acute Diffused Encephalomyelitis and suspected ADEM. MRI cervical spine with evidence of demyelination involving posterior cord. ICU course complicated by new onset of aphasia, partial left frontotemporal seizures, LGIB due to proximal rectal laceration and central diabetes insipidus. Admitted 3/15/21. On 3/17 he developed aphasia with right sided facial droop and stroke alert was called. Later on 3/17 he developed GI bleeding and was taken for emergent colonoscopy, from which no significant conclusions could be made due to lack of preparation and subsequent poor visualization. No foreign body was reported. After he continued to have ongoing bleeding, the patient had a sigmoidoscopy, during which the migrated clip could be removed and two new hemostatic clips were placed. He subsequently developed large volume urine output and nephrology was consulted; the patient was diagnosed with likely diabetes insipidus. On 3/20 acyclovir was discontinued after HSV PCR was negative. High dose solumedrol for ADEM completed 5 day course 3/21. VDRL was non reactive. There were no oligoclonal bands. Solumedrol 1g daily was started 3/24/21: MRI showed L>R patchy enhancement and diffusion abnormalities consistent with ADEM. Repeat MRI showed new restricted diffusion of the left superior cortex, bilateral medial temporal lobes and hippocampi, genu of the corpus collosum, and pericallosal white matter, with ddx including status epilepticus, autoimmune encephalitis and infectious encephalitis including herpes simplex. Completed 5 day course of high dose steroids, 6 days of IVIG and on ongoing PLEX. Neurological improvement noted 3/25
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| 47 | 2021-03-28 | numbness, burning sensation, migraine |
Swollen lymph nodes Migraine headaches Burning in back of left thigh continuously Numbness in left...
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Swollen lymph nodes Migraine headaches Burning in back of left thigh continuously Numbness in left foot
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| 47 | 2021-03-28 | seizure |
Patient called into clinic to report about two hours after receiving vaccine he passed out and the p...
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Patient called into clinic to report about two hours after receiving vaccine he passed out and the person that was with him said he had a seizure. Patient reported feeling fine after about an hour, but was very tired and had a headache.
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| 47 | 2021-03-30 | weakness |
Chills, fever, muscle aches, joints pain for the first 4 days. On 5th day cough, generalized weaknes...
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Chills, fever, muscle aches, joints pain for the first 4 days. On 5th day cough, generalized weakness. I took Ibuprofen, vitamins, Airborne pills, Tylenol, antihistamines with some improvement. On 5th day due to caught and low grade temperature I started Augmentin 500mg po TID.
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| 47 | 2021-03-30 | bell's palsy | Pt's MD reports Pt developed Bells Palsy after 1st dose, 4 days later. |
| 47 | 2021-03-31 | pain in extremity |
sore arm; This is a spontaneous report received from a contactable physician, the patient, reporting...
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sore arm; This is a spontaneous report received from a contactable physician, the patient, reporting on himself. A 47-years-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number: EJ1685), via an intramuscular route of administration in the left arm on 17Dec2020 11:00 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced clinically significant adverse events and sore arm on an unspecified date. The outcome of event, clinically significant adverse events and sore arm, was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021021539 second dose
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| 47 | 2021-03-31 | seizure |
Pt received Pfizer vaccine dose 1 at 12:05pm, immediately experienced seizure for aproximately one m...
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Pt received Pfizer vaccine dose 1 at 12:05pm, immediately experienced seizure for aproximately one minute. Postictal state symptoms include agitation and confusion. At 12:20 pt is AOx4, BP 188/118, HR 116, O2sat 99% 8 LPM NRB. Pt transported via EMS to hospital to receive further care.
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| 47 | 2021-04-01 | pain in extremity |
Soreness on the left arm, Fatigué, Fever with chills remained for 2 days; readings ranged from 99.9...
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Soreness on the left arm, Fatigué, Fever with chills remained for 2 days; readings ranged from 99.9F - 101F
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| 47 | 2021-04-01 | pain in extremity |
Severe Chills, Fever 102.2 on Tylenol, Body Aches, Headache, Arm soreness. Began about 10 hours aft...
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Severe Chills, Fever 102.2 on Tylenol, Body Aches, Headache, Arm soreness. Began about 10 hours after shot. Next day, fever down to 99 on Tylenol, still body aches. During severe chills was having hallucinations (I'm sure related to the fever).
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| 47 | 2021-04-01 | tenderness, migraine |
starting on 2nd day after the shot, right side of torso become soar and the skin in that area became...
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starting on 2nd day after the shot, right side of torso become soar and the skin in that area became somewhat tender as if there was a rash. Then on the 3rd day, a few small pimples showed up in that area, near the belt line. Then on the 4th day, the pimples started to look more like a rash. Then on the 4th day the rash became raised and looked more like boils. On the 6th day, I went to the doctor and they believe it is shingles. Started antiviral treatment for shingles on the sixth day. This entry is being made on the 7th day, one day into the shingles antiviral treatment. Never had shingles before. Also, migraine headache started on the 7th day, but this is not uncommon for me.
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| 47 | 2021-04-03 | tenderness | tenderness at left side around waist and below, pea size lumps |
| 47 | 2021-04-05 | bell's palsy, facial paralysis |
Around 3/19/21 shortly after patient started taking the (flonase), He had what felt like earache/inf...
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Around 3/19/21 shortly after patient started taking the (flonase), He had what felt like earache/infection. that went away in a day or so, but started having issues with the left sided drooping of my face. My PCP diagnosed it Bells Palsy, some nerve got swollen up/aggravated.
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| 47 | 2021-04-05 | cold sweat |
Pfizer-BioNTech COVID- 19 Vaccine EUA: Paramedic noticed vaccine recipient's eyes roll back, and mil...
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Pfizer-BioNTech COVID- 19 Vaccine EUA: Paramedic noticed vaccine recipient's eyes roll back, and mild brief tonic (arms) preceding syncopal x1 activity, patient was pale, clammy. Paramedic held patient up in chair to avoid fall. Patient taken to OBS medic tent for observation for syncopal event. Observed, water offered, orthostatic positioning, rest. Patient walked out after recovery.
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| 47 | 2021-04-05 | pain in extremity |
tinnitus: high-frequency hissing/ringing non-stopping, volume - low, more on right ear. wakes me up ...
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tinnitus: high-frequency hissing/ringing non-stopping, volume - low, more on right ear. wakes me up at night. learned to train my brain to ignore. two weeks after the 1st vaccine shot, hearing another high-frequency ringing on right ear, louder, on and off, needing more effort to handle. other reactions: right after the 1st shot, felt face swelling. these symptoms disappeared 4 hours later. left arm sore for rest of the day, back to normal next day.
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| 47 | 2021-04-05 | pain in extremity | arm pain, dizziness, passed out x2. Evaluated by EMS-Refusal to transport. |
| 47 | 2021-04-06 | pain in extremity |
Huge lump on right underarm. Used pain medication and cold/hot compress for the pain and sensitivit...
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Huge lump on right underarm. Used pain medication and cold/hot compress for the pain and sensitivity. Fully recovered after one week.
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| 47 | 2021-04-06 | pain in extremity |
Delayed cutaneous hypersensitivity (started within 24 hours but has continued intermittently for now...
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Delayed cutaneous hypersensitivity (started within 24 hours but has continued intermittently for now up to 9 days after injection. Sore arm, mild pain and redness and itchy rash on forearm of the arm where the vaccine was administered.
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| 47 | 2021-04-07 | pain in extremity | Soreness in arm (worse than the first shot). Fatigue Fever chills |
| 47 | 2021-04-08 | tremor |
Patient was sitting in a chair drinking a soda being observed for 15 minutes after his first shot. ...
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Patient was sitting in a chair drinking a soda being observed for 15 minutes after his first shot. Ten minutes into his observation time, he started feeling sweaty, dropped his soda, started shaking and fell out of is chair face down. He gained cosciousness, turned onto his back and put his knees up. His blood pressure was 132/108. The ambulance was called. The patients vitals were normal whe the emt evaluated the patient. The patient refused treatment and called his wife to come pick him up and agreed to follow up with his primary care physician Monday.
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| 47 | 2021-04-08 | unresponsive to stimuli |
Client was in the observation area with his spouse post vaccination. Wife reported client dropped hi...
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Client was in the observation area with his spouse post vaccination. Wife reported client dropped his paperwork and became pale, diaphoretic and unresponsive. EMS responded immediately at which time the client was responsive, awake, alert and oriented. Client assessed and found to have vital signs within normal limits. 12 lead EKG performed and normal. Residual leg weakness improved quickly and patient was counseled regarding transfer to Emergency Department which was declined.
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| 47 | 2021-04-09 | weakness |
Severe chills; pain at injection site began at night and lasted until morning. All of the next day, ...
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Severe chills; pain at injection site began at night and lasted until morning. All of the next day, fatigue and weakness. Following evening, fever of 100.9
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| 47 | 2021-04-09 | weakness | Extreme fatigue, lack of stamina, runny nose and headache |
| 47 | 2021-04-09 | numbness |
Beginning on day 13-14 after injection, mild numbness from injection point to finger tips. Lasting t...
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Beginning on day 13-14 after injection, mild numbness from injection point to finger tips. Lasting to present.
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| 47 | 2021-04-09 | pain in extremity, flushing |
Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Sys...
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Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Vision changes-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Medium, Systemic: Visual Changes/Disturbances-Severe, Additional Details: Patient presented with sweating, and pale face. Chest pressure/pain and left arm pain. Face was pale. Pt reported nausea and vision bluring in and out. Reported unable to stand and verbalized the desire to call an ambulance to evaluate. 911 was called and all advice followed until EMS arrived. Rph remained with patient until EMS arrival. Pt had NO swelling of lips/eyes or difficulty breathing. No hives. Unable to reach patient to assess curent status
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| 47 | 2021-04-11 | weakness |
Patient reported he had SOB and trouble breathing while sleeping and his tongue felt "heavy" while e...
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Patient reported he had SOB and trouble breathing while sleeping and his tongue felt "heavy" while eating. Patient went to the ER at 1634 on 4/8/2021. ER report- positive for swollen tongue, weakness, negative for respiratory distress, Respirations were normal with mild scattered bronchial sounds
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| 47 | 2021-04-11 | numbness | Dizziness, vertigo, confusion, numbness in legs, loss of balance |
| 47 | 2021-04-11 | pain in extremity |
Same night as shot: right arm soreness lasting 24 hours 2 Days after shot: really bad diarrhea lasti...
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Same night as shot: right arm soreness lasting 24 hours 2 Days after shot: really bad diarrhea lasting 12 hours Both cleared up on their own
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| 47 | 2021-04-12 | weakness |
Pain from injection. Lasted 2 days. Bad dreams 12 hours after injection. Very low energy 30 hours a...
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Pain from injection. Lasted 2 days. Bad dreams 12 hours after injection. Very low energy 30 hours after injection with a metallic taste in my mouth, Aches and pains, diarrhea, nausea, racing heart, confusion, exhaustion, 5 days after injection energy is better. All other symptoms are slowly subsiding.
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| 47 | 2021-04-12 | cold sweat |
1430 PT SITTING IN POST VACCINE WAITING AREA AND HAD SYNCOPAL EPISODE. FALL TO FLOOR FROM CHAIR SITT...
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1430 PT SITTING IN POST VACCINE WAITING AREA AND HAD SYNCOPAL EPISODE. FALL TO FLOOR FROM CHAIR SITTING POSITION. PT TURNED TO BACK WITH ASSISTANCE FROM STAFF. PT QUICKLY REGAINED CONSCIOUSNESS AND NOTED TO BE WITH DILATED PUPILS AND TRYING TO FOCUS. NOTED CLAMMY SKIN. VS WITH HEART RATE IN 40'S WEAK RADIAL. BP 122/76. NOTED APPROX 1/2 INCH ABRASION TO RT TEMPORAL AREA FOREHEAD. PT ORIENTED TO SURROUNDINGS AND SITUATION. STATES "I TRIED TO RAISE MY HAND TO TELL NURSE I FELT FUNNY, THEN I FELT LIKE I WAS IN A DREAM AND WOKE UP WITH YOU ALL AROUND ME" EMS NOTIFIED IMMEDIATELY. PT DENIES ANY MEDICAL HX. VS MONITORED WITH BP 90/36 ON 2ND CHECK. EMS HERE AND TOOK POSSESSION OF PT
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| 47 | 2021-04-12 | pain in extremity | Arm pain, fatigue, trouble sleeping |
| 47 | 2021-04-13 | tingling, weakness |
Mild tingling in the right foot, tachycardia during the first 15 minutes after getting vaccinated. S...
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Mild tingling in the right foot, tachycardia during the first 15 minutes after getting vaccinated. Severe pain and swelling of the left shoulder, tachycardia or change in heart rate, mild swelling of the hands, mild headache, weakness and tiredness for 48 hours after the first 5 hours of getting the vaccine.
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| 47 | 2021-04-13 | sensory loss |
tongue and jaw swelling, numbness post vaccination similar to first vaccine. BP 132/99, o2 98%. Give...
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tongue and jaw swelling, numbness post vaccination similar to first vaccine. BP 132/99, o2 98%. Given zyrtec PO, symptoms improved. Doctor and EMT on site and released to go home.
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| 47 | 2021-04-14 | cold sweat, feeling hot |
Patient received his first dose of Pfizer vaccine on 4/14/21 around 4pm and the next day on 4/15/202...
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Patient received his first dose of Pfizer vaccine on 4/14/21 around 4pm and the next day on 4/15/2021 woke up with left deltoid soreness at the site of injection which pt. expected but otherwise felt well until around 11am when he developed lightheadedness, became clammy and diaphoretic and felt feverish. His temp was 98.0 (oral) during evaluation and Blood pressure slightly elevated 140/80s (did not take his BP meds yet) but otherwise unremarkable vitals with no orthostatic hypotension. Random finger stick glucose was 142. Pt. given Tylenol 2 tabs PO in clinic and a hydration pack with water and allowed to lay down in clinic. Pt. monitored for 1.5 hours and Vitals remained stable, lightheadedness resolved. Pt. still felt warm but no longer diaphoretic and remained afebrile and d/c home in stable condition. Symptoms reported via V-safe app by patient.
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| 47 | 2021-04-14 | flushing |
Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: A...
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Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Abdominal Pain-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Visual Changes/Disturbances-Medium, Additional Details: complained of heart burn and blood pressure rose
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| 47 | 2021-04-14 | numbness |
Site: Pain at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Dizziness / ...
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Site: Pain at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Joint Pain-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium
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| 47 | 2021-04-14 | tingling | Tingling in upper & lower extremities |
| 47 | 2021-04-15 | pain in extremity |
Headache, chills, soreness in legs, tired. Starting the morning after the injection and lasting all...
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Headache, chills, soreness in legs, tired. Starting the morning after the injection and lasting all day.
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| 47 | 2021-04-15 | pain in extremity |
Lower left leg pain, swelling and redness 3 days after 2nd dose of Pfizer Covid vaccine. Ultrasound...
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Lower left leg pain, swelling and redness 3 days after 2nd dose of Pfizer Covid vaccine. Ultrasound confirmed superficial blood clot from ankle to knee.
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| 47 | 2021-04-15 | tremor, feeling cold | Fever. Headache. Muscle pain. Chills. Shakes. |
| 47 | 2021-04-17 | pain in extremity, tenderness |
Purple or blue toes, cold to the touch, tender and sore. Three smallest toes on foot on same side as...
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Purple or blue toes, cold to the touch, tender and sore. Three smallest toes on foot on same side as receiving shot. Started about 4 days after receiving first shot of Pfizer. Worsened over about a day. Felt almost like bruising. Would no longer blanch when pressed or rubbed. Elevation helped. Seemed to stop progressing in severity by day 7.
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| 47 | 2021-04-18 | weakness | Severe shivering. Fever. Aching. Headache. No energy. Lasted all weekend. |
| 47 | 2021-04-18 | feeling cold, migraine |
Eye redness and puffy, migraines, fever cold chills, muscle pain and joint pain, it?s been five days...
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Eye redness and puffy, migraines, fever cold chills, muscle pain and joint pain, it?s been five days and eye almost closed completely. Wanted to report the blood shot eyes and puffy ness around left eye
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| 47 | 2021-04-18 | flushing |
Systemic: After patient was directed to sit down for 15 min to be observed. A few min after patient ...
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Systemic: After patient was directed to sit down for 15 min to be observed. A few min after patient sat down in chair he passed out and fell off his chair. Nurse gave epipen called 911. Had scrape on R front scalp and some blood on nostril.-Medium, Systemic: Flushed / Sweating-Mild, Additional Details: Patient reported that he had a phobia of needles prior to vaccination. Vaccine was given at approximately 2:50pm. After he fell, the nurse noted he was face down. The nurse asked him to roll on his back and he responded after a few moments. His skin was red, blotchy, and sweaty. Patient said that he was ok and didn't want to get sent to ER. Epipen was administered at 3:02pm on 3/17/21 and ambulance arrived 3:07pm. The nurse noted some improvement but pt was complaining of hand and arm pain.
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| 47 | 2021-04-18 | hypersensitivity of all senses |
@ 2 HOURS AFTER RECEIVING VACCINE, ELBOW STARTED TO BECOME SWOLLEN, RED, VERY PAINFUL AND HOT TO THE...
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@ 2 HOURS AFTER RECEIVING VACCINE, ELBOW STARTED TO BECOME SWOLLEN, RED, VERY PAINFUL AND HOT TO THE TOUCH. SYMPTOMS DO NOT APPEAR TO BE EASING. PAIN AND SENSITIVTY IS RESTRICTING MOVEMENT AND INTERFERING WITH NORMAL DAILY ACTIVITY. ALSO DAY OF VACCINCE - VERY ITCHY, NO RASH OR HIVES PRESENT.
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| 47 | 2021-04-20 | weakness |
Chills. Aching muscles and joints. Tired and weak. Lasted 36 hours. Slept 13 hours and treated...
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Chills. Aching muscles and joints. Tired and weak. Lasted 36 hours. Slept 13 hours and treated with ibuprofen.
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| 47 | 2021-04-21 | pain in extremity |
I got this second shot a month ago. My arm still hurts. It's not as bad as it was the night I got ...
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I got this second shot a month ago. My arm still hurts. It's not as bad as it was the night I got the shot but I have a constant pain in my left arm. A constant nagging dull pain.
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| 47 | 2021-04-21 | tingling, numbness | acute severe low back pain radiating to both legs, with bilateral leg numbness/tingling |
| 47 | 2021-04-22 | weakness |
5:41 patient mentioned feeling dizzy, weak and lightheaded. He sat down in a chair and began monitor...
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5:41 patient mentioned feeling dizzy, weak and lightheaded. He sat down in a chair and began monitoring symptoms. He said he has a history of seizures. At 5:45 after making sure he could take deep breaths and his airway was cleared, he took a sip of water. At 5:47 he mentioned having an increased heart rate. At 5:49, he willingly laid on the floor. At 5:51 he said his chest hurt and had a headache. At 5:53 he then sat up and took a few more sips of water. He felt comfortable enough to stand back and go home. He and his fiancé left the building. He vocalized that his fiancé will be driving him home.
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| 47 | 2021-04-22 | hot flush |
Site: Pain at Injection Site-Mild, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-M...
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Site: Pain at Injection Site-Mild, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypertension-Mild, Additional Details: Patient reported that he had difficulty hearing. Patient sat in the chair and then lost conciousness. He was laid down on the ground, vitals were checked, and water was given. Noted high blood pressure. Patient regained conciousness within 3-5 minutes. Vitals were rechecked and returned to normal.
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| 47 | 2021-04-22 | numbness |
Numbness radiating down left arm, numbness moving up neck and left side of ear and scalp. Multiple...
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Numbness radiating down left arm, numbness moving up neck and left side of ear and scalp. Multiple Hives on arms , chest, and back.
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| 47 | 2021-04-22 | tingling |
I myself a healthy physician with no prior medical illnesses received Pfizer COVID19 vaccine first ...
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I myself a healthy physician with no prior medical illnesses received Pfizer COVID19 vaccine first on 12/18/20 and second dose on 1/8/21 both doses at Hospital , ( they have the information of the lots)- Then on March 19th I started to develop an acute ascending sensory symptoms first in feet and then arms ; also involved torso . Sensory symptoms consisted of pins and needles and paresthesias . They persists on even today but less intense . Also had temperature dysregulation of the feet when shoes worn. There seem to have also some changes in my sweat gland activity. Saw my PCP and neurologist with working diagnosis of acute sensory neuropathy of unclear etiology. Though this could be idiopathic but like to check out if any association with COVID19 vaccine as this only association i could think about in healthy patient ie myself with no medial issues or any acute illness recently nor any systemic disorders to account for symptoms ; wanted to report so that you are aware and I personally wanted to see if this is being recognized in other vaccine recipients and might help me to arrive at a diagnosis.
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| 47 | 2021-04-25 | pain in extremity, numbness | SORE ARM, NUMB ARM, HEADACHE, NAUSER, TIRED, VOMIT. |
| 47 | 2021-04-25 | pain in extremity |
Moderate pain in the left arm. First injection was in the left arm and the second was in the right a...
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Moderate pain in the left arm. First injection was in the left arm and the second was in the right arm.
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| 47 | 2021-04-25 | pain in extremity |
On Saturday, April 24, around noon, I heard a ringing in my right ear, then it clogged up. The clogg...
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On Saturday, April 24, around noon, I heard a ringing in my right ear, then it clogged up. The clogged sensation changes depending on how much I move around, but it has not gone away. I can clear my eustachian tubes, so whatever it is seems to be further in the ear. I can still hear, it's just muffled in the right ear. The only other adverse reaction I've had was on Monday, April 19, where I had very sore hips/back around 8pm and around 11pm when I went to bed, I had chills as if I had a fever. Those symptoms were gone by the morning of Tuesday, April 20.
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| 47 | 2021-04-25 | tingling |
client complained of left hand tingling after receiving 2nd Pfizer. Client informed EMTs of new ons...
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client complained of left hand tingling after receiving 2nd Pfizer. Client informed EMTs of new onset of symptoms. PHN joined team shortly after. Per client had been in waiting area 20mins and new onset 8 mins ago. First vitals 1303: blood pressure: 130/90, pulse 74, oxygen 97%. Per client sensation to left hand as if "hand had fallen asleep". Sensory and motor intact on left hand. Client received vaccine in left deltoid. Client denied pain or radiation past wrist. Per client no reactions to first dose. Vitals 1308: blood pressure 120/80, pulse 71, oxygen 98%. Per client tingling sensation lessened. Medical history of diabetes, takes metformin. No history of allergies. at 1313 client ready to leave. Per client felt fine. EMT advised client to seek medical care of worsened symptom. Last vitals: blood pressure: 120/80, pulse 72, oxygen 98%. Client left facility with steady gait at 1315.
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| 47 | 2021-04-26 | feeling hot |
Patient complained of getting hot. While sitting in the chair, he fell to ground, hitting head on th...
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Patient complained of getting hot. While sitting in the chair, he fell to ground, hitting head on the back of the chair. This patient was evaluated by EMT and Nurse. Patient denies double or blurred vision, nor nausea or vomiting, nor headache, nor dizziness, but some soreness at back of head. No noted swelling at this site. At 3:44 pm, vitals were: O2 sat 97%, B/P 110/60, HR 86, R 20. Offered water and tolerated well. Patient's family accompanied him to this event. At 4:07pm, vitals , O2 sat 99%, B/P 112/68, HR 86, R 20. At 4:26 pm, paramedics were called, and arrived, and evaluated patient. Vitals now, O2 sat 100%, B/P 125/73, HR 76, R 20. Paramedics deemed patient stable to go home. At 4:35 pm, patient released to go home with family.
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| 47 | 2021-04-26 | numbness |
Rapid heart rate, slight nausea, slight numbness to front right cheek and lips. Onset within 1 minu...
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Rapid heart rate, slight nausea, slight numbness to front right cheek and lips. Onset within 1 minute of injection. No treatment given. Heart rate started to decrease after 10 minutes and returned to normal within 30-40 minutes. Numb areas returned to normal within 45-60 minutes. Slight feeling of anxiety for several hours, but this could have been simply from stress from the initial reaction. I also occasionally have random panic attacks and could have potentially had a small one at the onset of my face going numb which could have contributed to the length of unease.
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| 47 | 2021-04-26 | tremor, inability to speak, involuntary muscle movements, tingling |
At 1118 patient fainted, had fixed shaking, pale, loss of speech. Once patient reactted he was able ...
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At 1118 patient fainted, had fixed shaking, pale, loss of speech. Once patient reactted he was able to speak and gave Past medical history of Asperger syndrome and no fainting spells before. Patient complained of stomach pain. numb lip, tingling sensation on fingers. Hands began to flexion and tense up. Vital signs were with in normal range. clinet began to show normalized sign and symptoms. Ems was still called and was taken to hospital for furhter observation at 1153.
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| 47 | 2021-04-27 | pain in extremity |
pt start to feel leg pain 10 days after the injection and then shortness of breath a week later pt ...
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pt start to feel leg pain 10 days after the injection and then shortness of breath a week later pt was found with DVT and PE
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| 47 | 2021-04-27 | tingling |
Severe, Acute Inflammatory Demyelinating Polyneuropathy (Guillain-Barré syndrome), with no other an...
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Severe, Acute Inflammatory Demyelinating Polyneuropathy (Guillain-Barré syndrome), with no other antecedent upper respiratory illness or GI illness. First developed extremity paresthesias, followed by rapid onset and progression proximal > distal, upper >lower extremity weakness on 4/6/2021, reaching peak on 2nd day of IVIG (4/13) initially with subtle improvements on his 3rd dose of IVIG (4/14; received total 2g/kg over 5 days) and then rapid worsening since 4/21/2021 to quadriplegia and bulbar weakness, requiring intubation on 4/26. Now on plasmapheresis and still hospitalized.
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| 47 | 2021-04-27 | tremor |
Patient with history of throat constriction, lip tingling, headache, fecal urgency and chills/tremul...
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Patient with history of throat constriction, lip tingling, headache, fecal urgency and chills/tremulousness about 15-20 mins after Pfizer COVID-19 vaccination.
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| 47 | 2021-04-28 | weakness | GBS weakness |
| 47 | 2021-04-28 | speech disorder, difficulty speaking |
11:30 Shot administered at drive thru site 11:40-50 Feeling mild tingling on lips, back of throat fe...
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11:30 Shot administered at drive thru site 11:40-50 Feeling mild tingling on lips, back of throat feels dry, getting the urge to pass stool. In the mirror I see the arches around the uvula swollen and red 11:50 Inform the nurse. Body starts shivering, talking and breathing is labored- according to my wife my voice sounded very different. Nurse checks lungs through stethoscope and SPO2+ heart rate- All normal, does not detect any constriction of lung air passages. But I am panting while talking. 11:55 I decide to wait and monitor. Shivering slowly stops, breathing slowly starts to return to normal (in about 20 mins). The urge to pass stool stopped. 12:22 No change either way- Breathing is ok, but mild tingling around lips, and feeling of tightness at back of throat. I take 5mg Cetrizine HCl. [Note: My mouth and throat felt like I have felt in the past with a reaction to shellfish.] 1:15 Redness at back of throat is less, and I feel normal. I drive off the parking lot of the vaccination site Next day Throat feels sore, but otherwise ok
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| 47 | 2021-04-30 | bell's palsy | Bell's Palsy. Currently managing ok with a steroid and antiviral. |
| 47 | 2021-05-01 | feeling cold, feeling hot |
i was sick with flu like symptoms; i was sick with flu like symptoms; chills; hot; cold flashes; ach...
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i was sick with flu like symptoms; i was sick with flu like symptoms; chills; hot; cold flashes; achy; i am extremely tired; This is a spontaneous report from a contactable consumer (reported for himself). This 47-year-old male patient received second dose of BNT162B2 (Pfizer covid-19 vaccine, solution for injection, Batch/Lot number: EP6955) via an unspecified route of administration at left Arm on 17Apr2021 09:00, as a single dose for covid-19 immunization. The patient did not have any medical history or allergy to medications, food or other products. Concomitant medications were not reported. He received first dose of BNT162B2 (Pfizer covid-19 vaccine, solution for injection, Batch/Lot number: EP6955) via an unspecified route of administration at left Arm on 27Mar2021 09:00, as a single dose for covid-19 immunization. On 18Apr2021 07:00, he was sick with flu like symptoms, chills, hot, cold flashes, achy and felt extremely tired. He did not receive any treatment events. He did not visit doctor or other healthcare professional office/clinic or emergency room/department or urgent care. He did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was recovering from the events of sick with flu like symptoms, chills, hot, cold flashes, achy and felt extremely tired. He was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. No follow-up attempts are needed. No further information is expected.
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| 47 | 2021-05-06 | one side paralysis, numbness |
Guillain Barre syndrome; Doesn't feel from his waist down on left side; Doesn't feel from his waist ...
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Guillain Barre syndrome; Doesn't feel from his waist down on left side; Doesn't feel from his waist down on right side; Weakness on right side; Weakness on left side; Passed out; High blood pressure; Lost hearing on right side; Headache; Fever; Pain in back; Pain in neck that went up to his head; This is a spontaneous report from a contactable consumer. A 47-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 16Mar2021 at 15:00 or 15:10 (at the age of 47-years-old) as a single dose in the right arm for COVID-19 immunization. Medical history was reported as none. It was reported that the patient had no pre-existing conditions and was "100% healthy and normally ran every day for 2-3 miles." Concomitant medications were reported as none. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. The patient did not have a history of adverse events that followed prior vaccinations. The patient previously received the flu shot in Sep2020 (at the age of 47-years-old) for immunization and experienced no side effects. It was reported that the patient received a flu shot every year and experienced no side effects. On 16Mar2021 the patient experienced fever, pain in back and pain in neck that went up to his head; on 17Mar2021 the patient experienced headache; on 18Mar2021 the patient experienced does not feel from his waist down on left side, does not feel from his waist down on right side, weakness on right side, weakness on left side, passed out and on unspecified dates the patient experienced Guillain Barre syndrome, lost hearing on right side and high blood pressure. The events does not feel from his waist down on left side, does not feel from his waist down on right side, weakness on right side, weakness of left side and passed out (911 was called) required an emergency room visit; does not feel from his waist down on left side, does not feel from his waist down on right side, weakness on right side, weakness on left side and Guillain Barre syndrome also required a physician office visit. The patient was hospitalized for the events passed out, does not feel from his waist down on left side, does not feel from his waist down on right side, Guillain Barre syndrome, weakness of right side and weakness of left side from 18Mar2021 to 08Apr2021 (also reported as "for 22 days"). The reporter (friend of the patient) called to file a report for his friend, who did not speak any English. The reporter wanted to make Pfizer aware of the adverse event that the patient experienced. The reporter stated that the hospital staff stated that they reported the patient's adverse event to Pfizer, the local health department and the CDC, but the patient's family and friends were not sure if the report was filed, thus the reporter was calling. The clinical course was reported as follows: "6-7 hours after getting home from getting the vaccine on 16Mar2021, the patient started to feel fever, pain in his back, and pain in his neck that went up to his head. The hospital had given the patient Tylenol and the hospital staff informed the patient that if he felt a fever or pain after the COVID-19 vaccine, he should take the Tylenol. The hospital staff also informed the patient that if his symptoms got worse to call 911 and go to the emergency room. The patient took the Tylenol and his fever came down a bit and the patient went to sleep. On the next day, 17Mar2021, the patient's neck pain started going up more like a headache. On the morning of Thursday, 18Mar2021, the patient got weak. The patient could barely move his hand or neck or leg. After the weakness began, "it was like 1-2-3" and the patient was passed out. After the patient passed out, 911 was called and when emergency personnel arrived, the emergency personnel thought that the patient had had a stroke. When the patient woke up on 18Mar2021, the patient was unable to feel from the waist to all the way down. The medical staff at the hospital did a lot of testing on the patient, MRIs and all that stuff, and all of the test results were coming back negative. The medical staff took some fluid from the patient's back after the patient was in the hospital for 2-3 days. The results came back negative until 2 weeks later when the patient's friends and family were informed that the patient had Guillain-Barre Syndrome. The patient's left side got a little improvement with medicine, but the patient's right side did not get any improvement." The patient's fever was treated for the first few days while hospitalized, the patient no longer had a fever. The patient was also treated for high blood pressure for the first few days that he was hospitalized. The reporter was informed of the patient's hearing loss "after the patient started speaking good, about 3-4 days after the patient had the first dose of the COVID-19 vaccine on 16Mar2021. The patient was losing hearing before that, but the patient was not able to talk to the caller or family a lot." (as reported). The reporter did not provide details on medications administered during the patient's hospital stay. The reporter stated that the patient was just discharged from the hospital and sent home. The reported believed that the patient needed more care and more medicine and that he was not finished with treatment. The reporter stated that the patient should have been back to normal health before having been discharged from the hospital. He did not know why the patient was discharged. The reporter stated that the patient was sent home without any medicine and was still experiencing daily headaches. The patient took Advil Migraine for his headaches which did not work, or only worked for 10 minutes and then the pain would come back. The hospital referred the patient to a different facility. The reporter stated that the patient could not get an appointment with this facility for up to 2 months from now. The patient could not wait 2 months for relief. He could not be like that with a headache and no feeling on his right side for 2 months. According to a different doctor the patient needed "more IVIG, immunoglobulin and needed to get attention from a neurologist to watch him until he got better." The patient had an appointment scheduled with a neurologist for Monday 26Apr2021 at 08:00. The clinical outcome of the event fever was recovered/resolved on an unspecified date; does not feel from his waist down on left side and weakness on left side were recovering/resolving; does not feel from his waist down on right side, weakness on right side, lost hearing on right side, pain in back, pain in neck that went up to his head and headache were not recovered/not resolved and passed out, Guillain Barre syndrome and high blood pressure were unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up
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| 47 | 2021-05-06 | numbness |
Vertigo, Vomiting, Dizziness, face numbness, double vision, left arm is difficult to use, went t...
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Vertigo, Vomiting, Dizziness, face numbness, double vision, left arm is difficult to use, went to the emergency, given Meclizine, baby aspirin, Atorvastatin Calcium I still have difficulty walking, double vision comes and goes my balance is still off
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| 47 | 2021-05-10 | seizure |
generalized convulsion/second seizure witnessed by medical staff; elevated CSF protein to 79, CSF Gl...
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generalized convulsion/second seizure witnessed by medical staff; elevated CSF protein to 79, CSF Glucose 73; elevated CSF protein to 79, CSF Glucose 73; severe headache; confused; This is a spontaneous report from a contactable physician. A 47-years-old male patient received the first dose of BNT162B2 (PFIZER COVID 19 VACCINE), intramuscular on 22Apr2021 09:30 (Batch/Lot number was not reported) at age of 47 years as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient had been tested for COVID-19. On Friday 23Apr2021, patient woke up with severe headache, per wife was confused. Then had a generalized convulsion. Presented to the ED, had a second seizure witnessed by medical staff. Workup with MRI, CTA and LP were notable for an elevated CSF protein to 79, CSF Glucose 73, otherwise no structural abnormality was identifed. Patient was clinically improving after being treated with seizure medications as of 26Apr2021. The adverse event result in Emergency room/department or urgent care, hospitalization. Covid 19 pcr nasal swab on 24Apr2021 was negative. Outcome of events was unknown. Follow-up needed. Information about batch/lot number has been requested.; Sender's Comments: Considering a plausible temporal relationship , a possible contributory role of suspect product BNT162B2 to the reported event seizures, CSF glucose increased, CSF protein increased, headache, confusional state cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 47 | 2021-05-12 | numbness and pain in extremities |
neuropathy; ataxia; neurological deficits with headache; Headache; This is a spontaneous report from...
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neuropathy; ataxia; neurological deficits with headache; Headache; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm left on 16Mar2021 (Lot Number: En6208) (at age of 47-year-old) as single dose for covid-19 immunization. Medical history included high blood pressure, there was no known allergies. The patient's concomitant medications were not reported. The patient previously took the first dose of BNT162B2 on 23Feb2021 (Lot number: En6198) for covid-19 immunization. There was no other vaccine in four weeks. Adverse event: Headache occurred 10-15 mins after second vaccination. Persistent headache after 3 weeks of 2 COVID vaccination. After the 3 weeks (also reported as on 26Mar2021) started experiencing neurological deficits with headache. Symptoms include: motor sensory weakness, ataxia and neuropathy. Admitted to hospital for neuropathy and ataxia on 21Apr2021. AE results in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 21Apr2021.There was no COVID prior vaccination. The outcome of the events was not recovered.
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| 47 | 2021-05-23 | weakness, cold extremities, tremor |
Patient had become extremely paleness, sweating, coldness of the hands, light headed, dizziness, wea...
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Patient had become extremely paleness, sweating, coldness of the hands, light headed, dizziness, weakness, shaky like trembling sign of minor seizures.
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| 47 | 2021-05-25 | weakness |
fever keeps going up; 1st it was 99, then 100 and then 101; headache; body aches; Not feeling well; ...
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fever keeps going up; 1st it was 99, then 100 and then 101; headache; body aches; Not feeling well; weak; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A 47-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE ; lot number and expiration date were not reported), via an unspecified route of administration on 13May2021 at 15:00, (at the age of 47-years-old) at 1ST DOSE single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced fever and it kept going up, 99 at first, then 100 and then 101, had headache, body aches, not feeling well and weak in May2021 after the first dose. He stated he just took two pills of Tylenol Extra Strength. Treatment was given for the events. Patient wanted to know if it was normal to have a fever and other symptoms and how long it would lasts. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 47 | 2021-05-28 | feeling cold, pain in extremity |
I have diarrhea; intense body aches all over accompanied with fever; intense body aches all over acc...
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I have diarrhea; intense body aches all over accompanied with fever; intense body aches all over accompanied with fever; didn't have an appetite; I had a splitting headache; arm felt heavy like it was falling asleep; pain at the injection site that I expected and radiated down to my wrist.; pain at the injection site that I expected and radiated down to my wrist.; he had pain in his shoulder, arm and forearm down to his wrist; he had pain in his shoulder, arm and forearm down to his wrist; His hand on the left side (on the injection site arm) felt very cold; He is tired and exhausted too; This is a spontaneous report from a contactable consumer reporting for himself. This is one of the two report from same reporter. A 47-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCIN, Solution for injection), via an unspecified route of administration, administered in Arm Left on 28Apr2021 (Batch/Lot Number: EW0179; Expiration Date: Aug2021) as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 28Apr2021, within a half hour after vaccination the patient arm felt heavy like it was falling asleep and recovered on the same day (reported as His arm felt heavy for 3 hours). Eventually that turned into pain at the injection site that he expected, and the pain radiated down to his wrist. On 30Apr2021, he had a splitting headache for a couple days. On 02May2021, reported as the next couple days he experienced intense body aches all over accompanied with fever. Also, he didn't have an appetite. The outcome of the event splitting headache was recovered on 02May2021. Reported as "today he still doesn't feel 100%". On 03May2021, he had diarrhea (reported as Yesterday and today). He did not have a prescribing doctor. He went to the clinic from the local health department. The body aches were starting to go away. He kept himself informed and up with the science, but he was just mostly concerned the effects have lasted this long. On an unknown date in 2021, he had pain in his shoulder, arm and forearm down to his wrist. His hand on the left side (on the injection site arm) felt very cold. It felt as though it was not having the circulation it should. As that went away, he could feel the pain in the injection site. He had a splitting headache that lasted Friday, Saturday, and Sunday. He recovered completely. He didn't normally get headaches. He was tired and exhausted too on unknown date in 2021. It was reported that, he didn't typically take naps, but he took a nap yesterday. His stomach feels a little better, but yesterday and today he did have diarrhea. He was a very healthy person. The injection site pain has gone away on unknown date in 2021. The body aches are starting to go away (recovering). On an unknown date in 2021, the events wrist pain recovered. On an unknown date in May2021, the patient recovered from the event fever. The outcome of the event diarrhea was recovering. The outcome of the events decreased appetite, pain in his shoulder, arm, and forearm down, felt very cold, and tired and exhausted was unknown. No follow-up attempts are needed. No further information is expected.
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| 47 | 2021-05-28 | seizure |
getting lightheaded and dizzy all the time; Seizure; This is a spontaneous report from a contactable...
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getting lightheaded and dizzy all the time; Seizure; This is a spontaneous report from a contactable consumer (patient) and a consumer (patient's ex-wife/ roommate) A 47-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER2613 and expiration date not provided), via an unspecified route of administration, on 01May2021 (at the age of 47-year-old), at single dose, for COVID-19 immunization. Medical history included blood cholesterol, high blood pressure, ongoing seizures from 1991; patient was being hit in the head with a steel baseball bat 13 times, and had a lot of brain damage; and ongoing sleep. Prior Vaccinations (within 4 weeks) provided as no. Concomitant medications included ongoing topiramate (TROKENDI XR) for seizure, ongoing allopurinol (ELAVIL) for sleep, and medication for cholesterol and one for high blood pressure. Patient had been on topiramate a couple of months. They were working with him to get him better than he was because he was having a lot of the little ones. He got the pill packs. He tried the little compartment things and they weren't working. Roommate suggested they try the pill packs to make it easier. There was the time on the packs. The patient experienced seizures on 13May2021; getting lightheaded and dizzy all the time on unknown date. Patient's second dose was scheduled 22May2021. Due to symptoms that he experienced he was afraid to take second dose. Patient had petite mal seizure last night on 13May2021, he got ahold of the doctor and got an appointment with his family doctor. They don't know about the seizure yet. Patient was feeling ok until he got the shot. Now, he was back to getting lightheaded and dizzy all the time. Patient got social security and had a hard time remembering his phone number. Patient's ex-wife clarified that patient called the doctor and got an appointment. He had upcoming appointment. The doctor wanted him to go to the emergency room. She had known him since 2005. When he had a mild seizure the ER doesn't do anything for him. They just leave him in the bed and wait until he comes to his senses. She just told patient to go in his room and lay down and offered him paracetamol (TYLENOL) and all that stuff. She couldn't move him when he was having one of the worse seizures because he turns into a board. She tried to get him aware. They didn't last long. Patient had grand-mal seizures since the age of 18 after being hit in the head with a steel baseball bat 13 times. He had a lot of brain damage. The brain can't fix itself. She was the only one that knows how to handle him. Patient's ex-wife listed at the doctor office because patient had a hard time explaining things and stutters a lot, he can't answer right away. The seizure patient had yesterday was a petite mal seizure. It wasn't a full blown grand mal seizure. He had three different phases of seizures. He had the staring one where he was looking out in space. Then he had the next one that happened in the car. He sat down and put his head back to relax. She thought he was taking a break, but it was a seizure. She touches him to focus and get him back. At night was when he has the worst ones where he looses control of his bladder, foams at the mouth, and turns into a board. He can't bend. He has only had 3 of those in the time she had known him. The other ones he had quite often. The quicker he comes out of it the less headache he has after it. If they let it run its course he has a bad headache and nausea. She tries to open his eyes because he comes out better. One time when he had grand mal seizure she couldn't get him rolled over and had to get help. Even though it was saliva and he was foaming at the mouth she was afraid he would choke on it. He had one starring seizure shortly before the COVID vaccine. He had them a lot. If they take blood or run scan it won't show patient had a seizure. For a little while patient and his roommate weren't together. If he did have seizure during that time he got himself out of it. He has only had 3 bad ones since 2005. Patient told his doctor that he thought it was related to the COVID shot. Patient's ex-wife didn't believe that was what caused the seizure (She thought if it was related it would have happened within 20 minutes of getting the vaccine). She thought he just had one. It played in his mind that he had the shot. Patient's brain stopped growing when he was 18 due to damage. The outcome of the events was unknown.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Seizures, Dizziness and the suspect BNT162B2.
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| 47 | 2021-05-31 | weakness |
This is a spontaneous report from a contactable consumer (patient). This 47-year-old male patient r...
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This is a spontaneous report from a contactable consumer (patient). This 47-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number not provided), via an unknown route in the right arm, on 23Feb2021 12:45 (at the age of 47-year-old) at single dose for COVID-19 immunisation. No other vaccine was received in four weeks. Relevant medical history included COVID-19 from Dec2020. The patient did not have concomitant medications. On 01Mar2021, the patient developed runny nose, congestion, a little bit of weakness and tired. He said he felt like he did when he had the COVID-19 virus in Dec2020. He said when he had the COVID-19 Virus in Dec2020, he had the virus for a few days, and the virus was not bad. He clarified he had the COVID-19 Virus for like 10 days total. He clarified he had a runny nose, congestion, a little bit of weakness, and was tired. He said today (on 02Mar2021) his symptoms were not as strong as yesterday, clarifying his symptoms were down by maybe 20% from yesterday. He took some liquid dextromethorphan hydrobromide, guaifenesin, paracetamol, pseudoephedrine hydrochloride (DAYQUIL) for his symptoms. The events did not require emergency room visit/physician office visit. The patient was recovering from the events. No follow-up attempts are possible; information about Lot/Batch number cannot be requested.
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| 47 | 2021-06-01 | cold sweat |
Extreme body and joint aches; joint aches; extreme fatigue/ very tired; cold sweats; This is a spont...
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Extreme body and joint aches; joint aches; extreme fatigue/ very tired; cold sweats; This is a spontaneous report from a contactable consumer (patient). A 47-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 23Feb2021 09:00 (Batch/Lot number was not reported), age at vaccination of 43-years-old, as single dose, for covid-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing. The patient previously took nitric oxide and experienced hypersensitivity, received BNT162B2 dose 1 administered in Arm Left on 03Feb2021 01:00 PM (Batch/Lot number was not reported) for covid-19 immunisation. Concomitant medications included metoprolol (METOPROLOL) taken for an unspecified indication, start and stop date were not reported; simvastatin (SIMVASTATIN) taken for an unspecified indication, start and stop date were not reported; bupropion hydrochloride (WELLBUTRIN) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced extreme body and joint aches, extreme fatigue, cold sweats and was very tired, all on 24Feb2021. No treatments were given for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from the events on an unspecified date. No follow-up attempts are possible; information about lot/batch number cannot been obtained.
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| 47 | 2021-06-01 | pain in extremity |
Right shoulder and elbow pain with inflammation of tendons. Left knee pain with inflammation of the...
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Right shoulder and elbow pain with inflammation of tendons. Left knee pain with inflammation of the adductor tendons around the knee, enthesopathy of the right index extensor tendon
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| 47 | 2021-06-03 | muscle twitching |
I am suffering from facial spasm; Muscle underneath the eye keep pumping for couple of minutes; This...
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I am suffering from facial spasm; Muscle underneath the eye keep pumping for couple of minutes; This is a spontaneous report from a contactable consumer. A 47-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: ER8732), via intramuscular route of administration in the left arm, on 29Mar2021 as a 2nd dose, single for COVID-19 immunisation. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN6199), via unspecified route of administration in the left arm, on 08Mar2021 as a 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient underwent annual lab check up and the results were unspecified. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. On an unknown date, the patient experienced facial spasm and her muscle underneath the eye was pumping for couple of minutes. It was reported that it was became more serious on 09May2021. The patient wanted to find out how many people got the same symptoms like her. The patient did not received any treatment. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
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| 47 | 2021-06-06 | weakness |
Severe exhaustion. After 3 weeks I got a B12 shot at recommendation of doctor. Benefit has worn of...
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Severe exhaustion. After 3 weeks I got a B12 shot at recommendation of doctor. Benefit has worn off and I need to get another B12 shot. I went from running for an hour after work every day to having to take an hour nap after work if I want to make it through dinner.
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| 47 | 2021-06-06 | pain in extremity | DVT in left leg, painful swelling still today |
| 47 | 2021-06-07 | facial paralysis, bell's palsy |
Systemic: Bell's Palsy-Medium, Systemic: Ear pain as well-Mild, Additional Details: States issue sta...
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Systemic: Bell's Palsy-Medium, Systemic: Ear pain as well-Mild, Additional Details: States issue started 24 hours after vaccine. Right side of face is drooping and states has ear pain. He also stated same issue happen to him when he was younger and lasted for about 6 weeks. Stated he remembers being treated with steriods that which helped. I advised patient to seek medical attention from hospital/urgent care to see if they can help.
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| 47 | 2021-06-07 | pain in extremity |
pain in the arm is getting worse every week, throbbing pain 0 to 8 number in the arm.; pain at the i...
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pain in the arm is getting worse every week, throbbing pain 0 to 8 number in the arm.; pain at the injection site; This is a spontaneous report received from a contactable consumer (Patient). A 47-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left in Mid-afternoon on 30Apr2021 (Batch/Lot Number: EW0176) as 2nd dose, single dose for covid-19 immunisation. The patient medical history was reported as none. Concomitant medication was not reported. Patient family Medical History Relevant to AE was reported as none. Patient historic vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for covid-19 immunization on 31Mar2021. Adverse event following prior vaccination was reported as none. Patient did not receive any other vaccine within 4 weeks prior to the first administration date of the Pfizer vaccine. On 30Apr2021, had a little bit of pain, normal, where the shot was. From that time, about 1-2 times per week he had pain in that left arm. Pain had been progressively constant on 0-8 pain scale for the site where the shot was put in his arm. He called the CDC, just came from his doctor's office. He was following CDC protocols implemented on this. He had to get bloodwork-clarified he had bloodwork drawn today; doctor wanted him to get an ultrasound done on his arm and start steroids as prescribed. As soon as he got the shot, he felt some...what he thinks was an indication of he got a shot-his body protecting itself from foreign body. About a week later he started to develop more pain in that area and then it progressively got worse, throbbing. He just had an appointment with his doctor's PA at 08:30 this morning on 01Jun2021. He just had bloodwork drawn but had no information for that or any other relevant testing/investigations done to provide for report. He received second dose of Covid-19 Vaccine, which he verified as being Pfizer-BioNTech product from CDC vaccine record card, on 30Apr2021. He reported pain starting that day and progressively worsening. He asked how long this side effect is going to take, who is going to pay for this process because supposedly he has to pay for this; but this is basically a clinical trial and when in a clinical trial the company pays for this, right? He also mentioned that his first dose of Covid-19 Vaccine was on 31Mar2021, and second dose of Covid-19 Vaccine was on 30Apr2021; so, second dose administered 30 days after first dose. He reported that kept him within the 6-week window. The outcome wof the events was not recovered.
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| 47 | 2021-06-08 | pain in extremity |
tendon inflammation; red dots all over my legs; I could not just walk; on my left leg down I have a ...
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tendon inflammation; red dots all over my legs; I could not just walk; on my left leg down I have a bump and it's painful; on my left leg down I have a bump and it's painful; This is a spontaneous report from a contactable consumer or other non hcp. A 47-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 14May2021 (at the age of 47 years old) as 1st dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. No relevant medical history. The patient reported that he got first dose of PFIZER-BIONTECH COVID-19 VACCINE on 14May2021 and was scheduled to get his second dose on 04Jun2021. The patient looking for guidance if he should get a second dose today as he experienced adverse reactions after first dose. On 30May2021, when he woke up in the morning he could not just walk, stated never happened before. His right thigh, right leg completely painful, he got crutches and started to walk. On 31May2021, he went to emergency room, where they did an X- ray and blood tests for blood clots but they did not see any blood clots. They gave him some gel and some muscle relaxants and told him that maybe he had tendon inflammation, but he did not run or he did not even exercise. Now after 4-5 days (Jun2021), cannot walk and now he started walking a little bit, but pain was still there. His thigh was swollen, and he had red dots all over his legs and on his left leg down he had a bump, and it was painful. He also had this red and red dots everywhere. The patient underwent lab tests and procedures which included X- ray and blood tests: did not see any blood clots on 31May2021. The outcome of the events red dots all over my leg, tendon inflammation was unknown, i could not just walk was recovering, on my left leg down i have a bump and it's painful was not recovered.
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| 47 | 2021-06-09 | pain in extremity |
Blood pressure and it was 179/91/still 150 over 70 over 69 which is quite high for me; I felt feveri...
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Blood pressure and it was 179/91/still 150 over 70 over 69 which is quite high for me; I felt feverish; Rash with bumps on my forehead/Broken out rash, turned red; Face was red; Heart rate has also been high; Head hurt; My arm was a little sore; I was a little tired; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 47-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: ER8736), via an unspecified route of administration on 30Apr2021 (at the age of 47 years) as a 2nd dose, single dose for COVID-19 immunisation. The patient medical history included over active autoimmune disease, Rheumatoid arthritis. The patient concomitant medication included adalimumab (HUMIRA, Lot number and expiration date was unknown) 0.4 ml, once a week, a shot in his belly or leg all around for rheumatoid arthritis and Methotrexate (Lot number and expiration date was unknown) 2.5mg, took 6 of them once a week for rheumatoid arthritis and autoimmune. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: ER8731), via an unspecified route of administration on 09Apr2021 as a 1st dose, single dose for COVID-19 immunisation. On 30Apr2021, the patient at first experienced arm was a little sore and little tired. On 04May2021, patient felt bad, felt feverish. On Wednesday, he got a rash with bumps on his forehead. The BP was 179/91. Heart rate has also been high and this morning BP was 150/71. Patient was send home from work and he was feeling that from two days after he got the shot but it's been couple of days ago. The patient went in upstairs and then was sent to medical to that they said his face was red, "I didn't look like, look good" and took blood pressure and it was 179/91 and patient was sent home and told to stay home today (06May2021). Patient called his doctor and he said 'it would be risky' for a couple of days. This morning my blood pressure has come down some but it was still high, it wasn't near high as it was, run like 129, 130 over 58 or some like that and this morning it was still 150 over 70 over 69 which is quite high. But it has still come down a lot that's the reason patient called the doctor and he said take it easy, stay out of sun don't work stay at home and her said if you want to call Pfizer call them. The events have improved since yesterday, patient kept thinking he was running fever because his head hurt. But it started on Tuesday and it was Wednesday when someone sent me when the second time patient had broken out rash again and it has turned red. But yesterday (05May2021) it was 170 and 150 is way better today (06May2021. Patient informed that as directed he did not to take his medications, the Methotrexate and Humira. He did not take it within 7 days of taking the shot because he was told not to take it within 7 days of taking the shot, so he got off the medicine for the shot. The patient went for one actually two weeks ago or three weeks ago for his heart checkup and all that stuff, everything was fine, cholesterol was fine, everything was good. The outcome of the events was recovering. Follow up (06May2021 and 06May2021): This is a follow up spontaneous report from a contactable consumer (patient): Added product details (Expiry date, lot details), Concomitant drug details, events (face was red, broken out rash, turned red, blood pressure was 179/91/ run like 129, 130 over 58 or some like that and this morning I was still 150 over 70 over 69 which is quite high for him, fever, head hurt), reporter's comments and clinical course and narrative was amended accordingly. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
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| 47 | 2021-06-09 | pain in extremity |
My left arm has been sore for the last 5 weeks since the shot; This is a spontaneous report from a c...
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My left arm has been sore for the last 5 weeks since the shot; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: Em 9808) via an unspecified route of administration administered in arm left on 07Feb2021 09:00 AM as first dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications was not reported. Facility type vaccine was reported as other. The patient was not tested with Covid infection prior to Covid vaccination. The patient was not on any other vaccine four weeks prior to Covid vaccine. The patient was not on any other medications two weeks prior to Covid vaccine. On 07Feb2021 at 10:00 AM, the patient experienced left arm had been sore and was there for the last 5 weeks since the shot. The patient had not received any treatment medication for the resulted events. The patient received Pfizer other vaccine (unspecified) on 26Feb2021 on left arm. The outcome of the event was not recovered. No follow-up attempts are possible. No further information was expected.
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| 47 | 2021-06-10 | difficulty speaking |
Within 20 minutes my throat felt tight and I had trouble swallowing. My voice sounded froggy; Within...
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Within 20 minutes my throat felt tight and I had trouble swallowing. My voice sounded froggy; Within 20 minutes my throat felt tight and I had trouble swallowing. My voice sounded froggy; Within 20 minutes my throat felt tight and I had trouble swallowing. My voice sounded froggy; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Batch/Lot Number: EN6203), via an unspecified route of administration, administered in arm left on 28Feb2021 18:00 as single dose for COVID-19 immunization. Medical history included reaction to flu shot many years ago and known allergies from clams. Concomitant medications included tocopherol (VITAMIN E [TOCOPHEROL]); lisinopril; amitriptyline hydrochloride (AMITRIPTYLIN); rosuvastatin. No COVID prior to vaccination. The patient had not been tested for COVID post vaccination. On 28Feb2021 18:15, the patient experienced within 20 minutes my throat felt tight and he had trouble swallowing, his voice sounded froggy. The patient visited the emergency room/department or urgent care for the events. Treatment medications included Epipen, Benadryl and steroids. Outcome of the events were reported as recovered with sequel. No follow-up attempts are needed. No further information is expected.
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| 48 | 2021-01-03 | facial paralysis |
I had right sided headache for the first two days, then resolved. The right sided headaches recurre...
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I had right sided headache for the first two days, then resolved. The right sided headaches recurred along with right tongue numbness initially on 12/29/2020. The symptoms worsen on 12/31/2020 and severe on 1/1/2021. I was initially started on Valtrex thinking it maybe due to shingles but soon with the right sided facial paralysis, it was obvious it was Bell's Palsy and was started on steriods on 1/1/21 and also received acupuncture treatment on 1/2/21 which significant help improve the symptoms. I still have some residual weakness of the right eye with some tearing and mouth weakness.
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| 48 | 2021-01-04 | numbness |
Hypertensive crisis; Numbness to my left ear; progressively it went down to my mandible, my face and...
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Hypertensive crisis; Numbness to my left ear; progressively it went down to my mandible, my face and my left shoulder numbness; Radial blood pressure cough; This is a spontaneous report from a contactable nurse reporting for himself. A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration on 28Dec2020 at single dose for covid-19 immunization. Medical history reported as none. There were no concomitant medications. During the administration the patient did experience some types of reaction where it wanted medical supervision. So, basically when he did got the injection he was waiting for his 15 minute prolapse. But within probably he would say 7 to 8 minutes he started to experiencing some numbness to his left ear and usually he thought it was secondary to the that he had (not clarified) but progressively it went down to his mandible, his face and his left shoulder numbness and he was experiencing some numbness that radiate towards his fingertips only to the left side. At that time he waived to the Nurse to supervise and at that time he wait again and a Physician came over. He checked his pulse and noted that he had normal rhythm during the pulse check and at that time and he had Emergency medical technician (EMT) come over. The EMT checked his blood pressure he thought multiple times through the left and to the right brachial. He was having what they would consider a hypertensive crisis where systolic were in 170's, 180's, diastolic numbers were between like 120's and 130's and his heart rate was in 70's. So, initially it was not anxiety induced. But he do not have no blood pressure. They wanted he to go to the hospital to treat the hypertensive crisis that was in. The patient opted not to. So he went home in a quieter environment he did have a radial blood pressure cough that he had been checking his blood pressure rigorously, tried different techniques and now he was back to normal state to 120-130 systolic and his diastolic was 70-80. This instance was weird that he did not see as a part of one of the side effects listed with Pfizer BioNTech Vaccine. No treatment received for the events, because he had no history of hypertension it was just more of decreasing the ambient around he. At that time he wanted to go to a quiet environment, took a shower and check his blood pressure. He did orthostatic while laying down sitting up, standing up and he was not hypertensive. For the causality, the nurse stated, "I think it did. This is a fact I mean I was doing fine prior to administration and then this event is slowly subsiding." The outcome of the events was recovering.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported hypertensive crisis cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 48 | 2021-01-04 | pain in extremity, cold sweat, weakness |
weak from lack of nutrition; weak from lack of nutrition; Tired; stomach cramps; felt out of breath;...
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weak from lack of nutrition; weak from lack of nutrition; Tired; stomach cramps; felt out of breath; nausea; vomiting when exercised; headache; Sore arm; chills; no appetite; clammy hands/clammy hands and feet; very sore at injection site; This is a spontaneous report from a contactable other HCP (patient) reported for himself. A 48-years-old male patient received first dose of BNT162B2, via intramuscular in left arm on 21Dec2020 10:15 AM at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was hospital. Medical history included known allergies: Shellfish, Corn, Whitefish. The patient's concomitant medications were none. No other vaccine was received within 4 weeks prior to the COVID vaccine. No other medications were received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior vaccination and patient was not tested for COVID-19 since the vaccination. The patient experienced no appetite, clammy hands, very sore at injection site on 21Dec2020 (reported as day 1), sore arm, no appetite, clammy hands and feet, chills on 22Dec2020 (reported as day 2), no appetite, nausea, vomiting when exercised, headache, clammy, chills on 23Dec2020 (reported as day 3), no appetite, nausea, stomach cramps, headache, felt out of breath, clammy, chills on 24Dec2020 (reported as day 4), tired, clammy, headache on 25Dec2020 (reported as day 5) and symptoms resolved but weak from lack of nutrition on 26Dec2020 (reported as day 6). No treatment was received for all the events. The outcome of the events was recovered in Dec2020. The information on the Lot/batch number has been requested.
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| 48 | 2021-01-05 | pain in extremity | Arm soreness, headache for a day |
| 48 | 2021-01-06 | muscle twitching, numbness |
woke up this morning feeling slight numbness on my left cheek. The sensation is very similar to whe...
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woke up this morning feeling slight numbness on my left cheek. The sensation is very similar to when I receive a numbing shot from my dentist for dental work. The feeling of numbness comes and goes with varying levels of intensity. Sometimes twitching my cheek can make it go away; but it keeps occurring.
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| 48 | 2021-01-07 | night sweats | Chills, fever, night sweats, nausea, bad headaches |
| 48 | 2021-01-07 | tingling |
all joints hurt, right arm swollen from elbow down to fingers, tingle sensation in lower right arm a...
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all joints hurt, right arm swollen from elbow down to fingers, tingle sensation in lower right arm and fingers
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| 48 | 2021-01-09 | pain in extremity |
Arm soreness, chills, fatigue, headache lasted 24 hours. Had same reaction to the first dose, almost...
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Arm soreness, chills, fatigue, headache lasted 24 hours. Had same reaction to the first dose, almost identical.
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| 48 | 2021-01-10 | coordination abnormal |
three hours after administration felt fatigued (drunk) and uncoordinated. slept for four hours woke ...
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three hours after administration felt fatigued (drunk) and uncoordinated. slept for four hours woke up with no affects
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| 48 | 2021-01-10 | tingling, feeling hot |
Within 10 minutes felt a rush of heat down right arm and tingling in fingers. Then I felt it in the...
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Within 10 minutes felt a rush of heat down right arm and tingling in fingers. Then I felt it in the left arm, however the left arm stopped tingling within 24 hours, but my right arm still has the tingling , feels bloated in my hand and my arm feels restless.
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| 48 | 2021-01-12 | flushing |
This patient is a 48 y.o. male presenting to the emergency department with a chief complaint of alle...
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This patient is a 48 y.o. male presenting to the emergency department with a chief complaint of allergic reaction s/p 1st COVID vaccine at 1330 this afternoon. Patient states he became very flushed to his face/chest 2-3 minutes after receiving the vaccine. EMS was on scene and evaluated the patient. He was found to be a little confused/disoriented upon questioning which quickly resolved. Patient was also having mild difficulty swallowing, however states he was not gasping for air. He had an IV placed for precautions, however no medications were given. Patient was transferred here for evaluation. He currently feels asymptomatic aside from a dry throat. Patient denies having any hives, shortness of breath, or syncopal episodes. He also denies having prior episodes of anaphylaxis requiring epinephrine.
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| 48 | 2021-01-14 | numbness and pain in extremities |
Fatigue starting at 22:00 Impaired night vision starting at 0500 1/9/22 Rigors starting at 0500 1/9/...
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Fatigue starting at 22:00 Impaired night vision starting at 0500 1/9/22 Rigors starting at 0500 1/9/21 Neuropathy in the hands starting at 0500 1/9/21
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| 48 | 2021-01-14 | pain in extremity |
Dark purple bruise on injection site about 2 in in size discovered the night of inject 10Sep2020. Pa...
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Dark purple bruise on injection site about 2 in in size discovered the night of inject 10Sep2020. Painful to the touch.; Dark purple bruise on injection site about 2 in in size discovered the night of inject 10Sep2020. Painful to the touch.; Dark purple bruise on injection site about 2 in in size discovered the night of inject 10Sep2020. Painful to the touch.; Left shoulder and arm pain; arm pain; This is a spontaneous report from a contactable pharmacist (patient). A 48-year-old male patient received the second dose of BNT162B2 (Lot number: EL1283), via an unspecified route of administration from 09Jan2021 08:30 at single dose in the left arm for COVID-19 immunization. Historical vaccine included BNT162B2 (Lot number: EH9899), received first dose via an unspecified route of administration on 19Dec2020 10:45 at single dose in the left arm for COVID-19 immunization. There were no medical history. Concomitant medication included ibuprofen on 11Sep2020 11:00. On 09Jan2021 09:00, the patient experienced dark purple bruise on injection site about 2 in in size discovered the night of inject 10Sep2020. Painful to the touch. Left shoulder and arm pain. Did not alleviate as of 10Nov2020 when report submitted. No treatment received for the events. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was not recovered.
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| 48 | 2021-01-14 | cold extremities | Headache, Cold Feet and Hands, Chills, body aches. |
| 48 | 2021-01-17 | weakness |
During 15 minute observation period post vaccine individual became slightly diaphoretic and felt wea...
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During 15 minute observation period post vaccine individual became slightly diaphoretic and felt weak. He does comment that he has not had much to eat or drink. Was offered juice and a snack which he tolerated and improve his symptoms. Vital signs were taken stable with slight tachycardia that improved at second set of vitals. Seen by provider on site and physical exam was benign. No medication intervention was needed. Left observation on own recognizance
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| 48 | 2021-01-17 | tingling | Herpes Zoster, L3 dermatome developed 14 days after first dose of vaccine |
| 48 | 2021-01-17 | tremor, pain in extremity |
After the injection my arm got really sore. I began to feel really tired and begin to have chills a...
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After the injection my arm got really sore. I began to feel really tired and begin to have chills and shakes. I started having diarreah and began throwing up. I had a sever headache and body aches which all symptoms lasted for about 3 days and I felt so bad so on Wed 12/30 I went to Urgent Care and was given fluids which did make me begin to feel a little better. On Monday I was sent for a COVID test which was negative. On Friday 1/1 i was finally able to return back to work.
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| 48 | 2021-01-18 | feeling of body temperature change |
Patient reports fatigue, soreness and swelling to the injection site, hot and cold flashes, joint pa...
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Patient reports fatigue, soreness and swelling to the injection site, hot and cold flashes, joint pain and muscle soreness and lethargy
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| 48 | 2021-01-18 | muscle spasms |
6 hours after receiving vaccine I developed frequent loose stools. This continued for two days, on t...
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6 hours after receiving vaccine I developed frequent loose stools. This continued for two days, on the 3rd day I developed cramping with loose stools. This continues today. I am using pedialyte to keep my hydration, immodium AD and probiotics for the diarrhea. No fever; mild chills
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| 48 | 2021-01-18 | pain in extremity | Fatigue, Headache, Sore arm, Achy muscles |
| 48 | 2021-01-18 | tingling, numbness |
After the administration, I was monitored for 15 minutes and I was fine. I left the hospital, start ...
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After the administration, I was monitored for 15 minutes and I was fine. I left the hospital, start driving, and suddenly felt that my right arm was heavy, numb, with a tingling sensation. I stopped the car and called the nurse and I was told that it will go away, and I can take a tylenol/motrin. It improved over the next hour and I felt it resolved a few days later but then it returned on 1/18 but not to the same extent, and I also felt intermittent tingling and numbing in my right foot. I also experienced intermittent episodes of fast heartbeats and missing heartbeats since the vaccine almost daily. I was fatigued and extremely thirsty for 3 days but that resolved completely.
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| 48 | 2021-01-19 | weakness |
Severe side effects - Swollen facial features especially evident in lips; began approximately 0730, ...
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Severe side effects - Swollen facial features especially evident in lips; began approximately 0730, 14JAN21 - 17JAN14; used diphenhydramine (50 mg ) at night to control swelling - weakness - fast heartbeat Side effects (each of the side effects lasted around the same time period, 13JAN21-17JAN21; alternated acetaminophen and ibuprofen to try and relieve symptoms -injection site pain (began about 1 hour after injection) -headache (severe) -muscle pain -chills - joint pain (severe), began during sleep and I first felt it in my hands - fever (even while taking acetaminophen and ibuprofen, I still had a fever of 100.6 degrees) -injection site swelling (13JAN21-19JAN21) -injection site redness
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| 48 | 2021-01-20 | migraine | Body aches Migraine Cough High fever Massive Dizziness Runny nose Fatigue |
| 48 | 2021-01-21 | feeling jittery, weakness, feeling hot, tingling |
Hot and tingling face and hands, slight dizziness and weakness, pulse 130-140, high level of anxiety...
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Hot and tingling face and hands, slight dizziness and weakness, pulse 130-140, high level of anxiety. Symptoms came on suddenly, after about 30 minutes they began to subside slightly. Returned to 90% of normal after approximately 2 hours. Remained jittery for another 6 hours after that.
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| 48 | 2021-01-21 | numbness, tingling |
8 minutes after the vaccine i satrt to experience some tingling to my left earlobe. It then radiated...
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8 minutes after the vaccine i satrt to experience some tingling to my left earlobe. It then radiated to my left jaw line where i felt an onset of numbness. the numbness hten radited to my left shoulder all the way down to my left extrremity digits. atthat time i waived over a nurse who waived a physician who check my radial pulse, pulse was noted in the 70's. At that time the physician asked a EMT perofrmed four evalautions of my BP and my BP was reading syttolically between was 140-150 and my datolics was reading 110-115. Throughout that time the numbness was still to my left side of my face and shoulder and arm and to myfingers. This was only localized to those two areas. At that time it was requested for me to go to the hospital to seek medical attention. I deferrred to going home to check my BP and at that time i was running 150/100. The numbness was still present and mu thought process my body was stressed out. I then took a nice cold shower with breathing techniques. I did orthastatics on myself. I then followed with my PCP the next day and she ordered bunch of labs, CRP, triponents, CBC, bubble study and chest x-ray and EKG. ALl the testes were deemed to be negative. My systolics were 120/80 when i saw my PCP, however i was recommedned to take the whole week off and was recommended to go back to work after the new year. After five days the numbness went away to my digits went away but not to my face. My grips were equal. I had no Bal palsy nor stroke. The numbness sill persisted up till day 9 and the umbness to the face went away.
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| 48 | 2021-01-21 | pain in extremity |
I received the first dose of Pfizer EK5730 at 18:07 on 12-30-2020. For the first day my arm was a b...
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I received the first dose of Pfizer EK5730 at 18:07 on 12-30-2020. For the first day my arm was a bit sore but nothing to bad. The next few days 48-72 hours later I started to have many more symptoms, some minor to sever including joint pain, headache, fatigue, and dizziness. lesser included some nauseas. The joint pain was so bad at one point i had to pull over while driving. on 1-2-21. as of writing this now 14 days out I still have some joint pain especially in my arms. No other symptoms of note. I would add that I tested positive for COVID -19 on 10-18-2020 and was not released from quarantine until 11-5-20 I did seek treatment during this time through by calling my Dr. did not require any hospitalization.
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| 48 | 2021-01-21 | pain in extremity |
Some background: I normally react badly to flu/respiratory vaccines in that I generally get sicker a...
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Some background: I normally react badly to flu/respiratory vaccines in that I generally get sicker after the vaccine than I do when I get the virus. So this isn't entirely unexpected. However, the timing is really strange and Now I wonder if I should get COVID tested. Here is the chronology of events. Day of shot (Friday) - pain in arm lasted about 2 days but wasn't too intense. As the pain in the arm began to fade, I started getting really sleepy. I slept probably 48 hours over the next three days but did not experience any pain except maybe slight muscle aches and a little of the accompanying eye burn that is associated muscle aches and sleepiness. By Tuesday, the sleepiness had passed. Thursday night (last night), I started to experience ALL general symptoms of a respiratory flu/COVID. I developed an intense cough and associated phlem (though it is very sporadic rather than persistent) and the precursors to intense muscle pain. I woke up at around 3am Friday with a fever, the muscle pain, burning eyes (associated with flu-muscle pain and fever), and extreme chills (though my windows was open... a normal practice as my computer makes it hot in my room). I felt oddly rested however, as though the getting sick, while making me tired, was also helping me sleep better. My body is definitely reacting to something. If it wasn't 6 days afterward, I would say it was my normal reaction to virus shots. However, the timing is alarming. I have not knowingly been exposed to anyone with COVID. This morning the chills are gone, the fever is down (though not entirely gone), but I still feel "down for the count." Like I said... it is my normal reaction to virus vaccine except that it is about 6 days late (usually sets in within 24 hours). This morning is the week "anniversary" of the shot.
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| 48 | 2021-01-23 | numbness | Reported numbness in left side of face and left arm , improved after 1 day, |
| 48 | 2021-01-24 | pain in extremity |
Arm is very painful. The day after achy, muscle pain, head ache fatigue and chills. Just lasted 4 to...
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Arm is very painful. The day after achy, muscle pain, head ache fatigue and chills. Just lasted 4 to 5 hours.
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| 48 | 2021-01-25 | muscle spasms |
Patient called on 1/25/21 and reported to the pharmacist that he was having severe pain in the shoul...
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Patient called on 1/25/21 and reported to the pharmacist that he was having severe pain in the shoulder that was radiating up to his neck and causing muscle spasms. He reported to his doctor who told him to report to the pharmacy as we administered the vaccination. Patient stated he has tried ice, heating pad, Tylenol, ibuprofen, and has seen a chiropractor with no relief.
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| 48 | 2021-01-25 | muscle spasms |
Patient called on 1/25/21 and spoke with pharmacist. He reported that he is still having pain at inj...
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Patient called on 1/25/21 and spoke with pharmacist. He reported that he is still having pain at injection site including muscle pain that is radiating into his neck and causing muscle spasms. He reported it to his doctor who told him to contact us at the pharmacy who administered the immunization. Patient reported using ice, heating pad, Tylenol, Ibuprofen, and has seen a chiropractor and still has no relief.
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| 48 | 2021-01-27 | tingling |
1/20/21 vaccinated. 1/21 afternoon-itchy feeling on top of buttocks, tingling sensation consistent w...
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1/20/21 vaccinated. 1/21 afternoon-itchy feeling on top of buttocks, tingling sensation consistent with herpes II/Zoster, nerve down right leg tingling, testing for all venereal diseases June 18, 2015, July 2015-Present married to wife no sexual activity outside of marriage, hyper sensitive to venereal disease. Wife is negative, PT is negative for IGA and IGE, PT received vacc and is now showing symptoms positive for herpes 2, PT is waiting for results as to if he is POSTIVE, blister on right side of penis-clear fluid filled, right sores/blisters crusty on buttocks, right inner thigh leg blister on scrotum with red dots in the middle, nothing on glands penis/urethra or anus. Thursday night, pt had intimacy and it was dryer than normal, uncomfortable on the right side with penetration-skin is compromised. Saturday, PT was not feeling great, shaft not showing, in a rush to urinate, scrapped scrotum and now has lesions. Sunday, fatigue, outbreak/whelp on legs, PT wore gauze/bandages to prevent chafing. Monday, shaft not showing, patient went to urgent care. PT was told it presented as Zoster. Nothing on penis at this point in time. Penis issues did not show until 1/26/2021. EX wife had herpes II. PT again was tested after in 2015 and was negative for IGE and IGA. Tuesday, patient started meds from urgent care. Wednesday morning, chest pain/pleurisy like-pain across chest. Arm vaccination site sore, bruised to this day. Herpes Zoster not typically going to end up on shaft, its unusual, PT is probable he has cross contaminated by itching his buttocks and then going to the restroom and touching right side of penis.
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| 48 | 2021-01-29 | nerve pain, numbness | numbness and pain along the ulnar nerve distribution of left arm c/w brachial neuritis |
| 48 | 2021-01-31 | bell's palsy | Bells Palsy |
| 48 | 2021-02-03 | sensory loss, weakness |
Ulnar nerve swelling causing entrapment at left elbow and wrist. Loss of sensation left ulnar nerve ...
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Ulnar nerve swelling causing entrapment at left elbow and wrist. Loss of sensation left ulnar nerve distribution 2 days after first vaccine. EMG demonstrated demyelinated neve with conduction velocity of 17 m/s. Loss of sensation. Motor weakness.
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| 48 | 2021-02-05 | tingling | Patient complains of tingling and swelling of fingers and toes starting day after vaccine. |
| 48 | 2021-02-07 | cold sweat | Chills, fever, cold sweats, nausea, diarrhea, headache. All lasting @ 48 hours. |
| 48 | 2021-02-07 | tingling, numbness |
Hands and feet turned pale blue and were numb to touch 3 days after vaccine. Hands and feet swelled...
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Hands and feet turned pale blue and were numb to touch 3 days after vaccine. Hands and feet swelled 5 days after vaccine and alternate between normal and swollen (cannot wear rings). Day 7 noticed nerve tingling sensations at random sites (arms, legs, back, hips). Random 'pop-up' welts that subside after 20-30 minutes. Tingling and random swelling inside lips.
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| 48 | 2021-02-08 | tingling | Shortness of breath, tight lungs, tingling of face, tight lips, very dizzy, and extremely fatigued. |
| 48 | 2021-02-08 | tingling | tight lungs, shortness of breath, tingling face, tight lips, extreme fatigue, dizziness |
| 48 | 2021-02-10 | pain in extremity |
bakers cyst behind my right Knee; pain and swelling in my right knee/ calf and ankle/in the right le...
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bakers cyst behind my right Knee; pain and swelling in my right knee/ calf and ankle/in the right leg/in left hand; pain and swelling in my right knee/ calf and ankle/in the right leg/in left hand; pain and swelling in my right knee/ calf and ankle/in the right leg/in left hand; pain and swelling in my right knee/ calf and ankle/in the right leg/in left hand; This is a spontaneous report from a contactable consumer (patient). A 48-years-old male patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, lot number EH9899, via an unspecified route of administration in left arm on 06Jan2021 at 09:00 at single dose for COVID-19 immunization. The patient received vaccination in Doctor's office/urgent care. Medical history included bladder cancer from an unknown date, cancer treatment with tumor vaccine therapy BCG (Bacillus Calmette Guerin) on 23Dec2020, bone spur in right thumb from an unknown date, COVID-19 from an unknown date and drug allergy to amoxicillin/clavulanate potassium (AUGMENTIN). The patient has not been tested for COVID-19 since the vaccination. Concomitant medication included doxycycline. On 08Jan2021 (also reported 3 days after the vaccine) at 05:45 the patient experienced pain and swelling in his right knee/calf and ankle. Pain and swelling in the right knee, calf and ankle continued until 14Jan2021 when the patient went to the urgent care. He was sent to the emergency room with a suspected blood clot and ultrasound proved no clot was in the leg. On 15Jan2021 the patient went to a hematologist and had an additional ultrasound which found a bakers cyst behind his right knee. He continued to have pain and swelling in the right leg and left hand which had already arthritis and he suspected it was an immune response to the vaccine. Rest, ice, compression and elevation were suggested as therapeutic measures to treat the events. The reported events had not resolved yet at the time of the report.
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| 48 | 2021-02-11 | feeling hot | low grade fever headache eyes were warm breath is warm lethargic |
| 48 | 2021-02-11 | pain in extremity, weakness, cold sweat, feeling cold |
Within 30 seconds pain on my arm and it increased slightly. I was able to do my work. But every time...
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Within 30 seconds pain on my arm and it increased slightly. I was able to do my work. But every time I was stable and tried to use it again I felt pain again. Pain was always there - it was tolerable. I was told to take Ibuprofen about three hours later. Second day, I could feel it but I didn't take medication. It slowly went away. No swelling, nothing. On January 4th started having symptoms nose bleeding; diarrhea; cold sweats; had a fever - but I didn't take it to know what it was. I very tired/ extremely sleepy; my eyes started feeling warm- these symptoms creeped up on me. It started around 10:00 am and within an hour an a half I had to tell my boss and they told me to leave work - but I couldn't drive. I stayed in my car and just slept and I was extremely tired. I had a coworker keep an eye on my because I looked really bad. I slept two or three hours in my car. I was still tired and I couldn't drive yet. So I stayed in my car a little longer until I felt stronger and drove home. I had started coughing and knocked out - but I was beginning to coughing a lot on drive home- the first hour I couldn't sleep because I was coughing so much - lasted an hour. Chest coldness for a couple of days - cold chest. It wasn't tight. Next day, January 5, 2021 - went to doctor and they ordered COVID test. Dr thought I had a stomach virus. Diarrhea continued for two days. Weak and fatigue for 5 days. My Fever - temperature was on the first day was one day only. Second day, I did have a lot of fatigue and I was coughing a lot. The fatigue lasted 10 days.
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| 48 | 2021-02-16 | numbness | left Lower jaw and neck Numb, Pain in shoulder (not at inection site), headache |
| 48 | 2021-02-16 | tremor, weakness, feeling cold |
I awoke from sleep freezing cold. Colder than I have ever felt. violent shakes. So much that I wa...
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I awoke from sleep freezing cold. Colder than I have ever felt. violent shakes. So much that I was worried my muscles would begin to sieze up and cramp. I had warm clothes and 5 blankets and could not get warm for over 2 hours. Elevated heart rate and breathing. Nothing warmed me. Eventually (and with ibuprofen) the incident subsided. I felt weak and just "off" with slight body aces and fatigue for the next day and a half.
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| 48 | 2021-02-19 | feeling hot, tremor | Difficulty breathing, swelling of throat, cough, warmth in chest, dry mouth, chills, violent shaking |
| 48 | 2021-02-24 | flushing | Facial flushing, diaphoresis, nausea, patient refused to be seen by EMS |
| 48 | 2021-02-25 | inability to speak | throat tightness, difficulty speaking and breathing |
| 48 | 2021-02-27 | pain in extremity, migraine |
Dose Given 1/20/21, sore arm after 1/20/21. Migraine headache developed evening 1/21 Intermittent ti...
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Dose Given 1/20/21, sore arm after 1/20/21. Migraine headache developed evening 1/21 Intermittent tinnitus developed 1/21/21. Woke up with subjective hearing loss/fullness Left ear and mild vertigo with nystagmus on morning of 1/23/21.
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| 48 | 2021-02-27 | seizure like phenomena |
Aural symptoms and seizure like symptoms. Patient has been seizure free for eight years with Zonegr...
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Aural symptoms and seizure like symptoms. Patient has been seizure free for eight years with Zonegran controlling tonic/clonic seizures. The patient experienced persistent seizure like aural symptoms, ringing in ears for four to five hours post onset and post dictal tiredness.
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| 48 | 2021-03-03 | numbness |
I had numbness in fingers in left arm. I still exp it now it's not as bad. I'm scheduled to have a E...
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I had numbness in fingers in left arm. I still exp it now it's not as bad. I'm scheduled to have a EEG later this month with the Neurologist.
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| 48 | 2021-03-03 | seizure |
Patient had two witnessed seizure like episodes with nystagmus and unresponsive each episode lasted ...
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Patient had two witnessed seizure like episodes with nystagmus and unresponsive each episode lasted less than 20 seconds. Patient had prodrome prior to both events but no memory or either event. Both event happened within 15 minutes of vaccine administration. Patient was transported to the emegency department for further testing and care.
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| 48 | 2021-03-06 | weakness |
2/05/2021 @ 5pm: Received first dose (no adverse reaction) 2/26 @ 6:20pm: Second dose (no immediate ...
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2/05/2021 @ 5pm: Received first dose (no adverse reaction) 2/26 @ 6:20pm: Second dose (no immediate adverse reaction) 2/27 @ 6am: woke up and felt fine 2/27 @ 7am: feeling of being hungover (dizziness, slight nausea, slight headache, mild chills) 2/27 @ 10am: low-grade fever of 99.5F, general ashiness, moderate headache 2/27 @ 1pm: fever of 100.4F, severe headache, general weakness/achiness 2/27 @ 4pm: fever of 101.4F, severe headache, general weakness/achiness 2/27 @ 7pm: fever of 102.0F, extreme headache, general weakness/achiness 2/27 @ 10pm: fever down to 99.0F (without any medications), extreme headache, loud ringing in the ears -- took 1 dose of ibuprofen 2/28 @ 7am: normal body temp, mild headache, slight dizziness 2/28 @ 11am: mild headache, fever returned to 99.6F -- took 1 dose of acetaminophen 3/01 @ 8am: normal body temp, slight headache (especially when standing up or bending over), slight weakness 3/02 @ 8am: slight headache when standing or bending suddenly, mild episodes of dizziness 3/03: No noticed symptoms
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| 48 | 2021-03-07 | flushing |
Flushing/sweating, racing heart, and warmth over entire body. Initial BP 158/89 (pulse 80), 99% O2 s...
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Flushing/sweating, racing heart, and warmth over entire body. Initial BP 158/89 (pulse 80), 99% O2 sat. Final BP 135/80 (pulse 76), O2 sat 100%.
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| 48 | 2021-03-08 | pain in extremity |
swelling in left hand, first knuckles of index, middle and ring fingers also swelling in right index...
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swelling in left hand, first knuckles of index, middle and ring fingers also swelling in right index finger pain when making a fist in left hand itching in both hands especially between fingers duration: 36 hours before swelling started to subside took one Loratadine 3/9/21 7pm
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| 48 | 2021-03-12 | numbness |
Pt reported left periorbital headache and left arm numbness. Vitals signs were stable. Pt was observ...
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Pt reported left periorbital headache and left arm numbness. Vitals signs were stable. Pt was observed in car for 30 mins. Pt endorsed similar reaction to initial vaccine
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| 48 | 2021-03-14 | pain in extremity |
Was given shot in top of right shoulder straight into joint. Had infectious cellulitis in elbow tur...
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Was given shot in top of right shoulder straight into joint. Had infectious cellulitis in elbow turn into gangrene. Was hospitalised for 4days and had to have surgery to remove dead tissue and clean out infection!
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| 48 | 2021-03-16 | pain in extremity, tenderness | Pain and tenderness in legs quads and lower leg |
| 48 | 2021-03-17 | pain in extremity |
As per patient reporting : Sx: Sorearm; 10pm : Shivers ; Next day (1/12/21). 12pm : Nausea ; exhaust...
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As per patient reporting : Sx: Sorearm; 10pm : Shivers ; Next day (1/12/21). 12pm : Nausea ; exhaustion, feelings i was going to die ; unable to sleep at night for 2 nights. As per my evaluation : Patient presented with worsening of psychosis and manic sx.
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| 48 | 2021-03-18 | pain in extremity | Sore arm on day one then day 3 fever chills and aches muscle aches and just for the night day 4 okay |
| 48 | 2021-03-18 | tremor | Chills and body shaking for 3-4 hours |
| 48 | 2021-03-19 | numbness, tingling |
* All of skin feels warm sensation to burning in left arm; sensation not crawling, not tingling, no...
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* All of skin feels warm sensation to burning in left arm; sensation not crawling, not tingling, not numb, not shooting pain, not pricking of pins and needles. * Upper body muscles tingling. * Muscles relaxed to weakness or numbness. * Feeling tired, sleepy, fatigue. * Forehead pressure; not congestion, headache, or fever. * Eyes tired and burning.
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| 48 | 2021-03-19 | numbness | FACE FEELS NUMB |
| 48 | 2021-03-20 | seizure | Seizures |
| 48 | 2021-03-22 | tenderness |
Weakness in muscles, joint pain, muscle pain and aches affecting movement, injection site pain, tire...
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Weakness in muscles, joint pain, muscle pain and aches affecting movement, injection site pain, tiredness/fatigue
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| 48 | 2021-03-22 | tremor, pain in extremity |
I received my first Pfizer/BioNTech vaccination at 1:00 PM on March 21, 2021. I was fine all day, b...
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I received my first Pfizer/BioNTech vaccination at 1:00 PM on March 21, 2021. I was fine all day, but near bedtime felt like something was beginning to happen. My upper left arm was also sore from the injection. I fell asleep at 11:30 PM and awoke at 1:00 AM with body aches and chills. I was never able to get back asleep the entire night. The following morning, March 22, I had body aches, chills, shaking and a terrible headache all day. All of these symptoms continued throughout the day and evening. I stayed hydrated with Gatorade and Sprite and ate very light foods. By the next morning, March 23, the headache was gone, but still have a little remaining of the body aches. No more chills or shaking. Moving slow still, but getting better.
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| 48 | 2021-03-26 | muscle spasms |
On 3/24/2021 about 1 hour, after I received the shot I started to have lower stomach cramps, they go...
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On 3/24/2021 about 1 hour, after I received the shot I started to have lower stomach cramps, they got more server as the night progressed. I could not sleep with the pain. Then on 3/25/2021 at about 2 am in the morning I started getting a headache while still having stomach cramps. At about 7:00 am I had a fever of about 99.5 degrees then at about 11:00 am I had a fever of about 100.2 degrees and the stomach cramps were still there. I drank lots of water and Pedialyte to stay hydrated but had a very difficult time urinating. it was very little. At about 10 pm the cramps started to subsided but were still lightly present. my appetite went to almost nothing but soup for 2 days, I have had leg and arm cramps off and on during this process as well. I did not want to eat. today 3/27/2021 is the first day I have started to feel normal.
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| 48 | 2021-03-28 | feeling hot |
After receiving the 1st dose of Pfizer COVID-19 vaccine, the patient moved to the observation area. ...
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After receiving the 1st dose of Pfizer COVID-19 vaccine, the patient moved to the observation area. After 5 min, patient reported feeling light-headed and tried to stand up. The patient sat down on the floor and leaned against the wall. Patient was able to stand and walk to the provider room for closer observation. Patient felt hot and looked pale. The provider placed a blood pressure cuff on the patient, at which point the patient slumped forward and stopped breathing. A carotid pulse was not able to be appreciated. The patient was pulled to the floor, positioned airway open and was given oxygen. BP was 96/40. Blood sugar was checked (104) and the AED pads were placed. EMS was called. AED advised no shock, patient had a pulse and was breathing. Patient gradually became alert, though reported not feeling well. Patient was disoriented and was not aware of passing out nor the current event. Repeat BP 115/50. Patient began vomiting (~300-400 mL). Patient left with EMS to be evaluated at local Emergency Department. Of note, patient reports history of vasovagal syncope events 2/2 to various situations.
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| 48 | 2021-03-28 | pain in extremity, slurring |
At around 10:00pm person stated that he began with swelling in mouth, "delirious", slurring of speec...
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At around 10:00pm person stated that he began with swelling in mouth, "delirious", slurring of speech, right arm pain, trouble breathing. These symptoms continued until 8:00am on 3/27/2021. No meds were taken at this time. Person did not go to ER for a visit and did not phone Dr.
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| 48 | 2021-03-29 | bell's palsy |
10 days following the second dosage of the Pfizer vaccine, patient developed Bell's Palsy. While we ...
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10 days following the second dosage of the Pfizer vaccine, patient developed Bell's Palsy. While we are unsure if it was related to the vaccine, we wanted to report the condition in hopes of helping others in the future.
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| 48 | 2021-03-29 | numbness |
patient complaining of tingling to tongue and numbness to upper back area. He was given 2 doses of b...
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patient complaining of tingling to tongue and numbness to upper back area. He was given 2 doses of bendaryl 12. mg/5ml. patient still wasn't feeling better after the Benadryl and was sent to the ER
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| 48 | 2021-03-29 | tremor |
PT was administered vaccine at 1025 and shortly there after started to shake, felt sweaty and just f...
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PT was administered vaccine at 1025 and shortly there after started to shake, felt sweaty and just felt weird. Then passed out. PT was quickly assisted by vaccination staff at car side and then medical staff was notified. Upon arrival PT was very pail and lacked color, but was awake and stated that he has never had that happen before. Denies any history of having adverse effects to medications. NKDA. Ambulance was called. 1045 Vitals BP: 80/60 Pul: 68 Sp02: 97 1045 Ambulance arrived 1050 BP: 92/58 PT was taken to local ER for further observation.
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| 48 | 2021-03-31 | cold sweat |
Patient reports sensation of heart racing as well as feeling clammy. He states that he is not light ...
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Patient reports sensation of heart racing as well as feeling clammy. He states that he is not light headed and does report history of anxiety, stating that he takes Xanax as needed. Symptoms come in waves and are short lasting. Patient was given juice and crackers and was monitored in medical observation. Reports feeling a "twinge" in vaccinated arm. BP 122/74
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| 48 | 2021-04-01 | feeling hot | Headache, hot feeling body |
| 48 | 2021-04-03 | tingling | Tinnitus. Moderate fuzzy tingly pitch. No treatments. |
| 48 | 2021-04-05 | numbness |
C?O numbness in legs, became confused, disoriented. Transferred to Emergency Department. Diagnosed ...
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C?O numbness in legs, became confused, disoriented. Transferred to Emergency Department. Diagnosed with CVA event. Still being treated at this time.
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| 48 | 2021-04-05 | tingling, pain in extremity |
Swollen/painful left arm, tingling in left finger tips, fever, chills, pain in left collar bone, ran...
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Swollen/painful left arm, tingling in left finger tips, fever, chills, pain in left collar bone, random abdominal pains, muscle aches
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| 48 | 2021-04-06 | weakness |
Anxiety, Panic, Weakness, unable to stand, generalized weakness. 98/60 68. Pt. observed with gene...
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Anxiety, Panic, Weakness, unable to stand, generalized weakness. 98/60 68. Pt. observed with generalized weakness. unable to keep eye open. Emergency personnel notified and pt. was transported to Hospital for further evaluation.
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| 48 | 2021-04-06 | nerve pain, tingling, pain in extremity, hypersensitivity of all senses |
DURING VACCINE, PATIENT FELT A SHARP TINGLING/SHOOTING PAIN DOWN HIS ARM. PAIN WENT AWAY, BUT HE WAS...
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DURING VACCINE, PATIENT FELT A SHARP TINGLING/SHOOTING PAIN DOWN HIS ARM. PAIN WENT AWAY, BUT HE WAS AWOKEN FROM SLEEP THAT NIGHT FROM THE PAIN. ARM WAS SORE AGAIN IN THE MORNING BUT THAT EVENING FELT AS THOUGH IT WAS SHOOTING AGAIN. PATIENTS WRIST STILL HAS TEMPERATURE SENSITIVITY AND CONSTANT NERVE PAIN, AND PATIENTS ARM IS SWOLLEN TO THE ELBOW.
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| 48 | 2021-04-06 | unresponsive to stimuli |
48 year old man recieved pfizer vaccine at 9:45am and began experiencing symptoms at 9:48am. Pt pres...
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48 year old man recieved pfizer vaccine at 9:45am and began experiencing symptoms at 9:48am. Pt presented diaphoretic with drool dribbling from his mouth with eyes rolling back, staring straight up with beats of horizontal nystagmus slumping in his chair. Pt did not respond to verbal or tactile stimuli. This episode lasted ~20 seconds. After this episode pt was AOx3 with eyes open. Pulse remained regular throughout the entire encounter. Denies: SOB, CP / dyspnea, HA, N/V, trauma, numbness, tingling, erythema. EMS was called to monitor vitals. Pt was transported via EMS to hospital (as per patients request), pt agreed to be transported. EKG was unable to be obtained due to chest hair. PMH: HTN, hyperlipidemia PMH: HTN, hyperlipidemia, Anxiety Meds: amlodipine, metoprolol, simvastatin, remapril, pepcid, lexapro Allergies: Penicillin (rash) Patient was advised for second dose of Pfizer to request to be laying down while getting the vaccine in case of a repeat episode or vasovagal risk.
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| 48 | 2021-04-07 | pain in extremity | Extreme soreness and pain at the injection site and throughout upper right arm and shoulder. |
| 48 | 2021-04-08 | one side paralysis, nerve pain, numbness, tingling |
Swollen lymph nodes under left armpit were severely inflamed when I woke up on Saturday 2/06/2021. 1...
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Swollen lymph nodes under left armpit were severely inflamed when I woke up on Saturday 2/06/2021. 1-2 days later I had severe pain on my Left back- ended up being my brachial plexus nerve. Few days after that I developed numbness and weakness on my left side and pins and needles in my Left index finger. I saw my primary care doctor twice that week. He started me on low dose Prednisone and gabapentin for the pain while sleeping. When the nerve pain/numbness did not subside, I asked for a neurology referral. Two doctors saw me for brachial plexus neuritis. I have had 2 ultrasound guided and one fluoro guided cortisone shots along the nerve. I have also been going to PT 2-3 x/week to regain my strength on the Left side & calm nerve.
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| 48 | 2021-04-09 | cold sweat |
Patient stated he was sitting in the chair and he started feeling clammy tunnel vision and blacked o...
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Patient stated he was sitting in the chair and he started feeling clammy tunnel vision and blacked out. he doesnt remember being brought over to the observation room. He was encouraged to drink fluids, patient stated he was feeling better and reported no further tunnel vision, he was escorted out with his son accompanying him. vital signs @ 1024 HR 62, BO 98/60 RR 18, pulse ox 96%, at 1027, HR 81, BO 111/65, RR 18 and pulse ox 95% on RA, at 1044 HR 62, BP 111/ 69, RR 18 and Pox 97%. He was released at 1045 by himself to the exit of the facility.
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| 48 | 2021-04-09 | pain in extremity | Sore arm, similar to a tetnus shot. Lasted around 36 hours. |
| 48 | 2021-04-09 | pain in extremity |
Patient was inadvertently given a COVID19 vaccine as the second dose after receiving a COVID19 vacci...
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Patient was inadvertently given a COVID19 vaccine as the second dose after receiving a COVID19 vaccine. Patient was given one manufacturer on 3/28/21 at another pharmacy and incorrectly thought he had missed his second dose. He came to our pharmacy to get the second dose, and it was not realized he had already received different manufacturer just 12 days before. Patient is not experiencing any unusual adverse effects, just a sore arm and drowsiness as would be expected after theCOVID19 vaccine.
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| 48 | 2021-04-09 | tingling |
shortness of breath; tight chest/lungs; tingling in face; tight lips; dizziness; fatigue; This is a ...
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shortness of breath; tight chest/lungs; tingling in face; tight lips; dizziness; fatigue; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EN6201), via an unspecified route of administration in right arm on 06Feb2021 at 05:30 PM at single dose for COVID-19 immunisation. Medical history included allergies to macadamia and brazil nuts, and was on medication for a few health issues. Concomitant medications included unspecified medication (medications in two weeks). No other vaccine received in four weeks. Patient has not tested COVID prior vaccination. The patient experienced shortness of breath, tight chest/lungs, tingling in face, tight lips, dizziness, fatigue on 06Feb2021 at 06:15 P.M. Events resulted in visit to doctor or other healthcare professional office/clinic. No treatment was given for events. Patient has not tested COVID post vaccination. The outcome of events was recovered with sequel. No follow-up attempts are possible. No further information is expected.
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| 48 | 2021-04-09 | tingling |
patient stated he was sitting after receiving the vaccine he start feeling a tingling feeling on his...
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patient stated he was sitting after receiving the vaccine he start feeling a tingling feeling on his forehead then he started feeling light headed then bust into a feverish sweat patient was assessed vitals are as follows 5:27p b/p 154/96 p 89 r 18 sat 100% 5:45p b/p 148/93 p 87 r 18 sat 99% 6:00p b/p 152/93 p 81 r 18 sat 99% patient stated he is feeling better patient will be wheeled out to the front entrance where patient will be released to go home.
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| 48 | 2021-04-11 | weakness |
Today on 12 April, 2021 I woke up feeling dizzy. I am also having nausea, feeling light headed, and ...
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Today on 12 April, 2021 I woke up feeling dizzy. I am also having nausea, feeling light headed, and a feeling of wanting to faint. Energy level feels down. Feeling slight confusion and disorientation.
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| 48 | 2021-04-12 | seizure |
Seizure lasting 2 minutes. Taken to er. Hospitalized for 3 days and all tests negative. Started on a...
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Seizure lasting 2 minutes. Taken to er. Hospitalized for 3 days and all tests negative. Started on anticonvulsants
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| 48 | 2021-04-13 | feeling hot, unresponsive to stimuli, seizure like phenomena |
Five minutes after receiving dose, stated he started to feel warm and light headed, so he sat down. ...
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Five minutes after receiving dose, stated he started to feel warm and light headed, so he sat down. He then lost consciousness, falling out of his chair and hitting his head. Staff at his side immediately; pale and extremely diaphoretic; started to come to after 10-20 seconds. He sat up immediately on his own. He was oriented to self, place, date. After about 30 seconds, stated he thinks he should lay down again. Lowered his head to the floor, blanket placed under his head and feet elevated using a chair nearby. BP 120/52 Sats 100%, HR 72. Cool packs applied to his neck and forehead. After 2-3 minutes requested to move him to the medical area. Got up to wheelchair, but lost consciousness again; head fell forward, appeared as if upper extremities stiffened and contracted, like sz activity. When in medical evaluation area, client was conscious, but starring blankly and not responding verbally. At 3:02, with assist of 2, moved to the cot to elevate his feet, but again, not responding to requests, such as lay down or elevate your feet, so assisted client to this position. Continues to be diaphoretic, pale and ashen. 911 called at 3:07. Informed him of this and the plan. Friend is by his side. Client denies allergies, states he takes meds for hypertension. 3:15 BP 100/56, HR 52, Sats 92%, hands cool to the touch. EMS here at 3:23; report given and client transferred to Hospital via ambulance.
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| 48 | 2021-04-13 | tingling |
48 yo healthy male no PMH - recent L leg fracture 10 months ago and has had surgeries for this -- n...
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48 yo healthy male no PMH - recent L leg fracture 10 months ago and has had surgeries for this -- no known allergies or other medical issues After 5 minutes --had swelling L ankle and then subsequently had paresthesias to L upper thigh and L arm and L chest No CP or SOB No fever or chills VItals normal 133/89 T 97.6 PO 97% P 68 Neuro exam: CN 2-XII intact Strength 5/5 + and symm bilat UE/LE Ambulatory No sensory difference No airway compromise Observed for 1 hour and feels slightly better --no worsening symptoms - L arm /chest tingling is gone, mild symptoms L ankle
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| 48 | 2021-04-14 | night sweats, tremor |
High fever onset 04/03/2021, chill and shakes, night sweats nightly until 04/13/2021; headaches cont...
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High fever onset 04/03/2021, chill and shakes, night sweats nightly until 04/13/2021; headaches continue Ibuprofen and Acetamenophen to reduce fever.
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| 48 | 2021-04-15 | feeling hot |
Feeling hot/chills about 10 hours after administration Fatigue and headache for 3 days , gradually i...
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Feeling hot/chills about 10 hours after administration Fatigue and headache for 3 days , gradually improving
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| 48 | 2021-04-16 | bell's palsy |
Development of Bells Palsy. At approximately 11 pm on 4/14/2021 noticed limited lip movement left s...
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Development of Bells Palsy. At approximately 11 pm on 4/14/2021 noticed limited lip movement left side. By next morning, left side of face paralyzed. Evaluated at ER approximately 8:30 am on 4/15/2021 who diagnosed episode of Bells Palsy. Advised to follow up with Primary first of next week and also follow up with Nuerologist in approximately 3 weeks.
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| 48 | 2021-04-16 | night sweats |
Extreme fatigue, constant headache that Tylenol and Ibuprofen would not help. Chills, fever, nig...
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Extreme fatigue, constant headache that Tylenol and Ibuprofen would not help. Chills, fever, night sweats.... from 6:00 p.m. to noon the following day.
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| 48 | 2021-04-17 | weakness, tremor |
Extreme dizziness and nausea resulting in fainting twice and hitting chin on furniture. Diarrhea al...
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Extreme dizziness and nausea resulting in fainting twice and hitting chin on furniture. Diarrhea all night at least once per hour. Chills and shaking. Sweats, very fatigued, no appetite, no sleep. Rested all Sunday, no more chills but still nauseous, diarrhea all day. No energy or appetite.
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| 48 | 2021-04-17 | weakness, tremor |
Upset stomach starting about 36 hours after injection. Stomach issues continued for 5 days; nausea; ...
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Upset stomach starting about 36 hours after injection. Stomach issues continued for 5 days; nausea; body shakes; weakness; fatigue; chills; This is a spontaneous report received from a non-contactable consumer reported for self. This 48-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 24Mar2021 11:30 AM Left arm as single dose (lot: EP7533) for COVID-19 immunisation. No pregnant at the time of vaccination. Medical history included Eosinophilic Esophagitis. Prior to vaccination, the patient did not diagnose with COVID-19. No allergies to medications, food, or other products. Concomitant medication included Omeprazole. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. He experienced Upset stomach on 26Mar2021 02:00 AM. Stomach issues continued for 5 days culminating in an episode of nausea, chills, body shakes, weakness, and fatigue. This episode passed fairly quickly in about an hour. Since the day after this episode have felt fine (approximately 48 hours). Since the vaccination, the patient has not been tested for COVID-19. No treatments were received. Outcome of the event Upset stomach was recovered on 31Mar2021 02:00. Outcome of the events nausea, chills, body shakes, weakness, and fatigue were recovered on 28Mar2021 02:00. No follow-up attempts are needed. No further information is expected.
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| 48 | 2021-04-17 | weakness |
I started shivering around 1am. It got so bad that my teeth were chattering, too. I slept poorly a...
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I started shivering around 1am. It got so bad that my teeth were chattering, too. I slept poorly and at 6am took my temperature. It was 101.4. I used a digital thermometer under the tongue. I took 2 acetaminophen at 8am. At around 10am my fever broke. My temperature stayed around 99 throughout the day. I felt "whoozy" and weak for the rest of the day. Today, April 18th at 10am I don't have any symptoms.
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| 48 | 2021-04-17 | pain in extremity |
Pfizer 1st Shot gave me loud Tinnitus and hasn't stopped.; headache; Had fever for a few days; fatig...
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Pfizer 1st Shot gave me loud Tinnitus and hasn't stopped.; headache; Had fever for a few days; fatigued; arm soreness; he was scared; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 17Mar2021 11:30 (Batch/Lot Number: EN6204) as SINGLE DOSE for covid-19 immunisation, age of vaccination 48 years old at workplace clinic. Medical history included Heart Disease and Covid-19 from an unknown date. No other vaccines in four weeks. Concomitant medication included losartan taken for an unspecified indication, start and stop date were not reported. The patient experienced loud tinnitus and hasn't stopped. Described as screaming High Pitch Ringing. Patient stated he was praying it will go away. Patient had headache, had fever for a few days, fatigued, and arm soreness on 19Mar2021 20:30 with outcome of not recovered. The patient underwent lab tests and procedures which included sars-cov-2 test (nasal swab): negative on 20Mar2021. Treatment was not received for tinnitus, headache, had fever for a few days, fatigued, and arm soreness. Physician office visit was made for tinnitus, headache, had fever for a few days, fatigued, and arm soreness. The patient stated "This is really scary stuff. Please stop blaming it on Covid". Patient further stated, "Since day 2 of shot which I got on St Patty's Day 17Mar2021. I am on Day 13 of this new hell with no end in sight". He filed a VAERS report and notified his Primary care Dr and ENT. Patient won't get the 2nd shot, as he was scared (Mar2021)." Outcome of the event scared was unknown while not recovered for the other events. The patient considered the tinnitus as serious (very serious and others have experienced this). No follow-up attempts are possible. No further information is expected. Lot number has been obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021366081 Same reporter/drug/AE, different patient;US-PFIZER INC-2021366082 Same reporter/drug/AE, different patient
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| 48 | 2021-04-18 | pain in extremity |
1). Fever (100.1) 2). Body ache 3). Lower left Leg moderate pain 4). Right under Arm pit swelling a...
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1). Fever (100.1) 2). Body ache 3). Lower left Leg moderate pain 4). Right under Arm pit swelling and moderate pain
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| 48 | 2021-04-20 | feeling hot |
VS: 106/67, SPO2 98%, HR 75, RR 18, Pt altered observational nurse, he was feeling hot and lighthead...
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VS: 106/67, SPO2 98%, HR 75, RR 18, Pt altered observational nurse, he was feeling hot and lightheaded. Pt fell to the ground, states he has a history of passing out with needles. Small laceration to forehead and small abrasion to nose. Within 10 minutes in observation hall pt states he felt much better. A&Ox3, with slight HA. Pt wife at bedside. Educated on s/s of when to seek medical attention. Ambulated with steady gait. Denies PMH, meds or allergies. Offered to call EMS to take to hospital, patients wife at bedside stating she feels comfortable taking the pt home. Educated on when to seek medical care if needed.
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| 48 | 2021-04-20 | tingling |
About 5 minutes after vaccination patient reported tingling feeling feeling all over his body. He a...
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About 5 minutes after vaccination patient reported tingling feeling feeling all over his body. He also said his throat "felt funny" but that symptom went away within 1 hour.
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| 48 | 2021-04-21 | flushing |
Syncope, flushing/sweating, dizziness. Patient fainted. BPs 99/57 (pulse 64), 103/61 (pulse 67). Giv...
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Syncope, flushing/sweating, dizziness. Patient fainted. BPs 99/57 (pulse 64), 103/61 (pulse 67). Given water, juice, crackers.
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| 48 | 2021-04-21 | throat numbness |
Approximatley5 minutes after the first vaccine dose, I experienced a slight numbing of the throat an...
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Approximatley5 minutes after the first vaccine dose, I experienced a slight numbing of the throat and minor difficulty swollwing. Breathing never seemed to be compromised. Symptoms last for about 1 hour.
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| 48 | 2021-04-22 | facial paralysis | right facial paralysis |
| 48 | 2021-04-22 | numbness, bell's palsy, facial paralysis |
Red patch on arm for about 10 days, he in size to 4"x6". Tingling on tongue. Pain on back of head fo...
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Red patch on arm for about 10 days, he in size to 4"x6". Tingling on tongue. Pain on back of head for several days, still continuing. Numbness in left jaw, Loss of muscle use on left side of face. Went to ER where they indicated Bell's palsy.
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| 48 | 2021-04-23 | numbness |
This was my first injection of Pfizer COVID vaccination in my left arm. I woke up next morning with...
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This was my first injection of Pfizer COVID vaccination in my left arm. I woke up next morning with my left hand partially numb. The thumb and right pointer finger feeling most of the numbness. The last three fingers had partial to no numbness. Today (04/24/2021), the numbness is still present. No pain is present, just the numb feeling.
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| 48 | 2021-04-23 | numbness |
4 weeks after 2nd dose, suffered minor head ?cloudiness? and numbness in right hand. Lasted about 1 ...
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4 weeks after 2nd dose, suffered minor head ?cloudiness? and numbness in right hand. Lasted about 1 hour
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| 48 | 2021-04-23 | muscle spasms, discomfort |
102° fever, extreme muscle aches (sharp pain, pressures, cramps), chills, lethargic and soreness a...
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102° fever, extreme muscle aches (sharp pain, pressures, cramps), chills, lethargic and soreness at injection area. Most symptoms began approximately 12 hours after the shot and lasted approximately 18 hours. Took Tylenol for fever and pain.
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| 48 | 2021-04-24 | discomfort |
swollen/inflamed gallbladder; swollen/inflamed gallbladder; discomfort; very sharp pain in my upper ...
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swollen/inflamed gallbladder; swollen/inflamed gallbladder; discomfort; very sharp pain in my upper right abdomen; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 11Mar2021 (Batch/Lot Number: EN6208) as SINGLE DOSE, 48 years old. Medical history included none from an unknown date. The patient's concomitant medications were not reported. No known allergies. No COVID prior vaccination. Not tested for COVID post vaccination. No other vaccine in four weeks. There were no other medications in two weeks. On unspecified date after first dose patient suddenly experienced very sharp pain in her upper right abdomen. Patient went to hospital. They could not pinpoint anything. The doctor believes it is a swollen/inflamed gallbladder. The pain lessened due to the new diet. I still have pain and discomfort. Scheduled for a gallbladder scan. Treatment includes change to low fat diet. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Outcome of the events were reported as not recovered. The second dose was administered in Arm Left on 01Apr2021 (Batch/Lot Number: EP7533) as SINGLE DOSE for covid-19 immunisation.
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| 48 | 2021-04-24 | pain in extremity |
Regular - Arm pain. Adverse - Abdominal pain / pressure, green stools, dizziness, fast heartbeat, a...
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Regular - Arm pain. Adverse - Abdominal pain / pressure, green stools, dizziness, fast heartbeat, anxiousness, irritation, body hyper alert, triggered.
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| 48 | 2021-04-24 | pain in extremity |
Headache; sore arm; This is a spontaneous report received from a contactable consumer (patient himse...
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Headache; sore arm; This is a spontaneous report received from a contactable consumer (patient himself). A 48-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection and Lot Number: EJ1685) via an unspecified route of administration in left arm on 04Mar2021 at 15:30 (at the age of 48-year-old) for COVID-19 immunisation. Medical history included allergies to tartrazine, gluten and penicillin. Concomitant medications were not reported. Patient previously took ciprofloxacin, differin and tessalon perle and experienced with allergy for all. On 04Mar2021 (stated within 1 hour of receiving vaccine) patient had headache and on an unknown date in Mar2021 (after first dose), patient had sore arm. Treatment was not received for the adverse events. Outcome for the event headache was not recovered and was unknown for sore arm.
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| 48 | 2021-04-24 | pain in extremity |
Sore Arm; Sore Throat/Scratchy Throat; Sore Throat/Scratchy Throat; Headache; Chills; This is a spon...
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Sore Arm; Sore Throat/Scratchy Throat; Sore Throat/Scratchy Throat; Headache; Chills; This is a spontaneous report received from a contactable consumer (Patient) reported for himself. A 48-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EK5730 and expiration date was not provided) and (lot number: EK5730 and expiration date was not provided), via an unspecified route of administration, in Arm left, on 25Mar2021 at 01:30 PM (at the age of 48-years-old) at a single dose for COVID-19 immunisation, at workplace clinic. Medical history and concomitant medications were not reported. Allergies to medications, food, or other products included: gluten, penicillin, ciprofloxacin, differin, tessalon pearls. The patient previously took first dose of BNT162B2 (lot number: EJ1685) on 04Mar2021 at 03:30 PM (at the age of 48-years-old) in Left arm for COVID-19 immunisation and experienced headache /sore arm started after first dose, headache started within 1 hour of receiving vaccine. Patient did not receive other vaccine in four weeks of vaccination. Patient did not receive other medications in two weeks of vaccination. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, post vaccination. It was reported that on 26Mar2021 at 01:00, the symptoms started after receiving second dose at around 1 am after 2nd dose, dose time was 1:30 pm day before sore arm sore throat/scratchy throat, headache, chills. The events were reported as non-serious. No treatment was received for the events. Outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.
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| 48 | 2021-04-25 | cold sweat |
Within 10 minutes of COVID #2 Pfizer vaccine at about 10:18am, patient developed lightheadedness, co...
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Within 10 minutes of COVID #2 Pfizer vaccine at about 10:18am, patient developed lightheadedness, cold sweats, and throat swelling sensation. Patient's temperature was low at 95.8 to 96.2.
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| 48 | 2021-04-26 | numbness |
Leg weakness and numbness, bladder dysfunction. Diagnosed with Gullian Barre after hospitalization 3...
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Leg weakness and numbness, bladder dysfunction. Diagnosed with Gullian Barre after hospitalization 3/17/21.
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| 48 | 2021-04-27 | speech disorder |
At approximately 1:30 on 4/28/2021, my throat started tingling on the left and right near my glands,...
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At approximately 1:30 on 4/28/2021, my throat started tingling on the left and right near my glands, and I had trouble speaking. I took three benedryl and then went to the ER at 2pm. They gave me a steroid in the ER, and also a prescription for prednisone. I returned home at 6pm
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| 48 | 2021-04-28 | weakness |
Client fainted after receiving the COVID-19 vaccine as per the vaccinating nurse. Attending nurse a...
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Client fainted after receiving the COVID-19 vaccine as per the vaccinating nurse. Attending nurse administered an ammonia inhalant. The client woke up, Fire Rescue arrived to evaluate client. Showed symptoms of weakness, diaphoresis and paleness. Client presented hypotension and bradycardia. Client needed to be transported to a hospital as per Fire Rescue. Client was transferred to Clinic by Fire Rescue at 3:27pm.
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| 48 | 2021-04-29 | tingling | Error: Shoulder Joint Injury (prolonged pain, tingling, etc.) |
| 48 | 2021-04-30 | pain in extremity, weakness |
syncope; Soreness overnight in left arm; expanding pain to left shoulder; Strong Fever/low fever; bo...
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syncope; Soreness overnight in left arm; expanding pain to left shoulder; Strong Fever/low fever; body pain; headache; felt uneasy; nausea/Felt like throwing up; dizzy/lightheaded; Profuse sweating; EKG showed low heart rate, blood pressure; EKG showed low heart rate, blood pressure; feeling weak; could not stand; Feeling worse; This is a spontaneous report from a contactable consumer. A 48-year-old male patient received second dose of BNT162B2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 14Apr2021 at 16:00 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. Medical history included Cholesterol (blood cholesterol abnormal) from an unknown date. There were no concomitant medications. The patient previously received first dose of BNT162B2 for covid-19 immunisation on 24Mar2021. The patient also previously received naproxen and experienced allergies. The patient experienced syncope, soreness overnight in left arm, expanding pain to left shoulder, strong fever/low fever, body pain, headache, felt uneasy, nausea/felt like throwing up, dizzy/lightheaded, profuse sweating, ekg showed low heart rate, blood pressure, feeling weak, could not stand and feeling worse all on 15Apr2021 at 13:00. All the reported events caused hospitalization for 1 day. It was reported that After receiving Pfizer vaccine at 4pm developed Soreness overnight in left arm, expanding pain to left shoulder. Strong Fever and body pain in morning. Feeling worse throughout morning after breakfast of tea and fruits. While having lunch at 1.30 pm felt uneasy and nausea and could not complete lunch. Felt like throwing up and got up feeling dizzy and lightheaded. Experienced syncope and had to lie down on kitchen floor. Tried to get up with help from family members but could not stand and had to lie down again on floor. Profuse sweating. Wife called 911 and ambulance who arrived and checked pulse, EKG showed low heart rate, blood pressure. Taken by ambulance and paramedics to hospital Emergency where IV fluids were given to stabilize and discharged after 4 hours of observation. Still feeling weak, headache, low fever. Taking Tylenol and fluids while recovering. Adverse event start date: 15Apr2021. Adverse event start time: 01:00 PM. The patient underwent lab tests and procedures which included blood pressure (blood pressure measurement): low on 15Apr2021, EKG (electrocardiogram): showed low heart rate, blood pressure on 15Apr2021 and pulse/heart rate (heart rate): low on 15Apr2021. Therapeutic measures were taken as a result of all the events which includes IV fluids and Tylenol. Outcome of all the events was recovering Information on batch/lot number was requested.
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| 48 | 2021-05-03 | weakness |
Site: Bruising at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Swelling at Inje...
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Site: Bruising at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: PE and DVT more prominent in/on the right side of body than left-Severe, Systemic: Vomiting-Medium, Systemic: Weakness-Severe, Additional Details: patient was diagnosed with COVID-19 in October 2020, but asymptomatic with underlying cough
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| 48 | 2021-05-07 | pain in extremity |
Left arm sore improved after first shot as well as after second shot; He had 101.1 degree fever; Exh...
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Left arm sore improved after first shot as well as after second shot; He had 101.1 degree fever; Exhaustion and extremely tired; His stomach was hurting a lot; lungs felt like someone reach inside inside and punched him in the lungs; Achiness in joint in any place he had problems in the past in his body; nauseated; came right up on Pulmonary oil micro embolism or POEM; This is a spontaneous report from a contactable consumer, reporting for himself. A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 intramuscular, administered in the left arm on 15Apr2021 at 12:00 (Batch/Lot Number: EN6204) as 2ND DOSE, SINGLE (at the age of 48 years old) for covid-19 immunisation; and testosterone cipionate (Perrigio manufacturer), via an unspecified route of administration from 2018 (Batch/Lot Number: 2005126.1; Expiration Date: Jul2023), at 200mg/ml. 100mg injected weekly for secondary hypogonadism . Medical history included hypogonadism from 2018, diagnosed allergies from an unknown date, compromised immune status from an unknown date, respiratory illness from an unknown date, genetic /chromosomal abnormalities from an unknown date, endocrine abnormalities from an unknown date, diabetes from an unknown date, and obesity from an unknown date. The patient's concomitant medications were not reported. Historical vaccine included flu vaccine over a year ago, and the first dose of BNT162B2 on 24Mar2021 at 12:30 injected intramuscularly in left arm for which he had a mild sore left arm. The patient experienced came right up on pulmonary oil micro embolism or poem on 16Apr2021 with outcome of unknown, left arm sore improved after first shot as well as after second shot on 16Apr2021 at 13:30 with outcome of unknown, exhaustion and extremely tired on 16Apr2021 at 00:30 with outcome of recovering, his stomach was hurting a lot on 16Apr2021 with outcome of recovering, lungs felt like someone reach inside inside and punched him in the lungs on 16Apr2021 with outcome of recovering, he had 101.1 degree fever on 16Apr2021 at 01:00 with outcome of recovering, achiness in joint in any place he had problems in the past in his body on 16Apr2021 with outcome of recovering, and nauseated on 16Apr2021 with outcome of recovered on 18Apr2021. Details were reported as follows: 16Apr2021 at 8-9 am he gave himself the testosterone injection and he felt that tickling, rough feeling in his wind pipe like he just had to cough hard. Caller states, "yesterday, 22Apr21, I gave myself the testosterone injection like I have always done, my wind pipe started feeling like I had to cough, it tickled and felt just like it did on 16Apr21 following the 2nd vaccine dose. I looked my symptoms up on line and found pome-(pulmonary oil micro embolism)." The patient underwent lab tests and procedures which included pyrexia: 101.1 fahrenheit on 16Apr2021. The action taken in response to the event(s) for bnt162b2 was not applicable, and for testosterone cipionate was unknown.
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| 48 | 2021-05-10 | feeling of body temperature change |
Hot and cold flash fever off and on Cough Muscle or body aches Headache Acute hypoxemic respirator...
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Hot and cold flash fever off and on Cough Muscle or body aches Headache Acute hypoxemic respiratory failure Pneumonia due to COVID-19 virus Received plasma therapy remdesivir dexamethasone?changed to oral Decadron upon discharge
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| 48 | 2021-05-10 | tenderness, pain in extremity, numbness |
Patient is a 48-year-old male with patient history significant for CAD, CHF, ICD, HTN, hyperlipidemi...
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Patient is a 48-year-old male with patient history significant for CAD, CHF, ICD, HTN, hyperlipidemia, and smoking who presented to the ED yesterday morning with 1 day history of chest pain. Patient described the CP as moderate aching in the substernal area that did not radiate. The pain was intermittent, with each episode lasting 1-2 minutes. The CP was associated with LUE numbness and SOB on exertion. The chest pain and LUE numbness have now resolved. Patient also reports a three week history of RUE swelling. The swelling gradually worsened and is now associated with pain and proximal RUE bruising. RUE pain is rated 5/10. In the ED, patient was found to have NSTEMI and small right lower lobe segmental pulmonary artery embolus. Venous Doppler was positive for occlusive thrombosis in the R subclavian, basilic, and cephalic veins. Patient was started on IV heparin. Patient is scheduled for cardiac cath today. Hematology is consulted regarding PE and RUE DVT. Patient denies personal or family history of blood clots or recent travel. Reports receiving COVID vaccine in LUE approximately three weeks ago. Also admits to being more sedentary recently due to being unemployed. Denies nausea, vomiting, bleeding, bowel changes, fever, or chills. Significant PE findings: RUE edema, firm and tender to palpation, ecchymosis on proximal RUE, distal sensation and active ROM intact
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| 48 | 2021-05-11 | tingling, muscle twitching |
Muscle twitching and tingling. First started in the right hand, but now it is also happening in both...
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Muscle twitching and tingling. First started in the right hand, but now it is also happening in both legs. Almost constant twitching. No pain.
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| 48 | 2021-05-12 | pain in extremity |
Became sore, achey, flueish and tired that night. Sore arm. Next 10 days was extremely tired altho...
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Became sore, achey, flueish and tired that night. Sore arm. Next 10 days was extremely tired although other initial symptoms cleared up in 36 hours after shot.
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| 48 | 2021-05-14 | one side paralysis |
Mini Stroke; Weakness on left side; memory loss; This is a spontaneous report from a contactable con...
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Mini Stroke; Weakness on left side; memory loss; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EW0153) via an unspecified route of administration, administered on the left arm on 20Apr2021 10:30 1st dose, single for COVID-19 immunisation. Medical history included COVID (prior to vaccination), pre-diabetic, anxiety, chest tubes and chest pain. The patient's concomitant medications were not reported. On 29Apr2021 22:00, the patient had a Mini Stroke. Also have weakness on left side and memory loss. The events resulted in Emergency room/department or urgent care visit/hospitalization. The patient was hospitalized for 2 days. Treatment was received for the events which included bloodwork, MRI, CT scan. Since the vaccination, the patient has not been tested for COVID-19. The facility where the vaccine was administered was in a pharmacy or drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of the events was not recovered.
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| 48 | 2021-05-26 | difficulty speaking |
voice had been messed up; hardly walk; Mild fever; Body aches; Muscle pain and joint pain in his hip...
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voice had been messed up; hardly walk; Mild fever; Body aches; Muscle pain and joint pain in his hips, shoulders, knees, and back of neck; Muscle pain and joint pain in his hips, shoulders, knees, and back of neck; This is a spontaneous report received from a contactable consumer, the patient. A 48-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EP7533), via an unspecified route of administration in the left arm on 30Mar2021 at 11:00 (at the age of 48-years-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EN6204) on 09Mar2021 (at the age of 48-years-old) in the left arm for COVID-19 immunization and had no events following the first dose. The patient did not receive any other vaccinations within 4 weeks of the vaccine. On 30Mar2021, the patient experienced body aches, muscle pain and joint pain in his hips, shoulders, knees, and back of neck. On Apr2021, the patient experienced a mild fever and could hardly walk. On an unspecified date, the patient's voice had been messed up. The course of events was follows: On 30Mar2021 at around 20:00-21:00, the patient had full body aches (further described as muscle pain and joint pain in his hips, shoulders, knees, and back of neck ) and then it got a little better for a couple of days. The patient woke up on 31Mar2021 and it was really bad. He tried to work through it. However, he finally went to the doctor and then the Emergency Room (ER) for the first time. He was put on meloxicam 15mg for 4 days and it didn't do anything, although it was reported he didn't take them all. On Apr2021, the first week after the second vaccine (also reported as a few days later, even up to 5 days), the patient had a mild fever, for one or two days it got up to 100.3 degrees F. The patient had not had respiratory problems or breathing problems. When the meloxicam didn't work, the patient went back to the ER. He received a steroid shot while there. He received 5 days of 60mg daily of prednisone. The patient felt fine when he was taking it, but when it wore off, he crashed real hard and was right back to where he could hardly move. After the prednisone wore off, he went back to the ER for the third time, on approximately 23Apr2021, because he could hardly walk. He was told to take ibuprofen and paracetamol (TYLENOL) until he could get into see his primary care. That was probably for about a week. The patient saw his new primary care and was so bad he had to use a wheelchair. The patient had regular blood panels completed with unknown results. The provider put him on the second round of prednisone, but he was told he couldn't keep taking it because it could really screw him up. He was prescribed prednisone 10 mg tablets to take 6 tablets for 3 days (for a total of 60mg), then 4 tablets for 3days, then 2 tablets for 3 days, then 1 tablet for 3 days and stop. He felt good at the beginning, but as the dosage went down, the medication wore off, his pain came back real bad. He was hurting really bad because he was tapering off the steroid, prednisone. He went in "last Friday" and they put him on duloxetine (CYMBALTA) 30mg by mouth once a day. He was also taking over-the-counter naproxen sodium (ALEVE) 220 mg about every 8 hours for pain. The patient was checked for "rheumatoid stuff" with unknown results. The patient was put on duloxetine because he was normally a very active person, but this had been debilitating, some days he cannot even get off the couch because of the pain and not being able to walk. He just started a new job and now he's not been able to work. For example, "today", the patient can hardly lift his arms above his head because his shoulders hurt so bad. The patient reported that the muscle and joint pain persisted, but some days the pain got real bad. "Yesterday" he couldn't even get up hardly to go use the restroom, he had to use a cane. This morning, he has been able to get up better today. The pain is just always there since this all happened. He can't move very good, it hurt so bad. The patient also added that his voice had been messed up since all of this. The patient underwent the following lab tests on 27Mar2021 COVID-19 rapid test: negative, on 09Apr2021 COVID-19 test: negative, on 10Apr2021 COVID-19 rapid test: negative. The clinical outcome of mild fever, voice had been messed up and hardly walk was unknown, of body aches and muscle pain and joint pain in his hips, shoulders, knees, and back of neck was not resolved. No follow-up attempts are needed; no further information expected.
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| 48 | 2021-05-26 | pain in extremity |
Starting 04Feb2021 I began having a headache; And then my left arm had pain radiating from my should...
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Starting 04Feb2021 I began having a headache; And then my left arm had pain radiating from my shoulder blade to my pinky; This is a spontaneous report from a contactable Other HCP (patient). A 48-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: EL1284) via an unspecified route of administration in Right arm on 12Jan2021 (at the age of 48-years-old) as 2ND DOSE, SINGLE for COVID-19 immunization. The patient's medical history included Herpes, eczema and concomitant medications included Truvada, escitalopram. Historical vaccine included first dose of COVID 19 (lot number= EH9899) via an unspecified route of administration in Right arm on 21Dec2020 at 07:00 AM. Patient had known allergies to Gluten/Wheat. The patient did not received any other vaccines within 4 weeks. The patient had no covid prior vaccination. Post vaccination, the patient was not tested covid. On 04Feb2021 at 08:00 AM, the patient reported that I began having a headache and then my left arm had pain radiating from my shoulder blade to my pinky. It has persisted for two days now and has made it difficult to hold heavy objects (10 lbs+). Though, it felt slightly better on day 2 than day 1. Treatment was not received. The outcome of the events was recovering. Follow-up attempts are completed. No further information is expected.
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| 48 | 2021-05-27 | facial pain |
5 days post second pfizer covid vacine, ~4/25 developed pain over right maxillary teeth and right si...
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5 days post second pfizer covid vacine, ~4/25 developed pain over right maxillary teeth and right sided red facial rash consistent with herpes zoster opthalmicus V1. Also developed zoster keratitis. Admitted to hospital where he received IV acylcovir x 4 days before transition to PO valtrex. Zoster rash resolved over time but then developed in mid May new diplopia and right pupilary dilation. Saw Opthomology who were concerned for CN3 defect. Represented and admitted to hospital where MRI was notable for right ocular motor nerve with questionable enhancement of right V1 nerve likely refelctive of post viral neuritis. Resumed IV acyclovir course x 10 days and started on PO prednisone taper.
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| 48 | 2021-05-31 | pain in extremity |
Swelling and pain to left arm from deltoid to fingertips; Swelling and pain to left arm from deltoid...
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Swelling and pain to left arm from deltoid to fingertips; Swelling and pain to left arm from deltoid to fingertips; This is a spontaneous report from a contactable nurse (patient also). A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: EL3248) via Intramuscular route of administration, administered in left arm on 03Feb2021 at 08:45 AM as 1st dose single for covid-19 immunisation in hospital. The patient medical history included hypertension. The patient had allergies with eggs. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient not been tested for COVID-19. The patient's concomitant medications included lisinopril, HCTZ and fexofenadine (within 2 weeks). On 03Feb2021, 09:00 AM, the patient experienced swelling and pain to left arm from deltoid to fingertips. The patient did not receive treatment for the adverse event. At the time of this report events outcome was not recovered. Follow-up attempts are completed. No further information is expected.
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| 48 | 2021-06-01 | bell's palsy |
Bell's palsy; This is a spontaneous report from a contactable consumer (patient) reported for himsel...
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Bell's palsy; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 28Apr2021 16:45 (Batch/Lot Number: EWO172) as 1st dose, single for covid-19 immunisation in Pharmacy or Drug Store. Medical history included myocardial ischaemia/Ischemic heart disease. Concomitant medication included acetylsalicylic acid (ASPIRINE) received within 2 weeks of vaccination. the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No Past drug event. The patient experienced bell's palsy on 13May2021 13:00. Hospitalization Prolonged was No. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19 included RT PCR SARS COV 2 on 09May2021: negative with Nasal Swab. treatment received for the adverse event included Corticosteroids, naproxen. Outcome of the event was recovering. Follow up needed, further information has been requested.
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| 48 | 2021-06-01 | pain in extremity, weakness |
I felt like 8-10 hours after the vaccine around 8:00PM, I experienced the general tiredness and weak...
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I felt like 8-10 hours after the vaccine around 8:00PM, I experienced the general tiredness and weakness and malaise. I had a low grade fever and body aches. 1-2 days after that around 01/06/2021 I felt like my legs were sore like I had done a leg work out. The fatigue and weakness lasted about 24 hours and the muscle aches lasted a couple weeks.
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| 48 | 2021-06-02 | cold sweat |
prolific cold sweats; Muscle pain; restlessness; severe chills; This is a spontaneous report from a ...
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prolific cold sweats; Muscle pain; restlessness; severe chills; This is a spontaneous report from a contactable Consumer. A 48-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EP6955) via an unspecified route of administration, administered in left arm on 06Mar2021 at 12.45 PM (at the age of 48-year-old) as single dose for COVID-19 immunization. The did not have allergies to medications, food, or other products. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to and since vaccination, the patient was not diagnosed with COVID-19. On 07Mar2021 (next day of vaccination) It was in the middle of the night (probably after midnight), the patient experienced muscle pain, restlessness, severe chills, prolific cold sweats. Did not received treatment for the adverse event. The outcome of events was recovering. No follow-up attempts are needed. No further information is expected.
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| 48 | 2021-06-02 | pain in extremity, burning sensation |
cranial pressure; has a burning pressure sensation in his head/ cranial pressure/ burning sensation ...
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cranial pressure; has a burning pressure sensation in his head/ cranial pressure/ burning sensation in forehead; the pain can move from one place on his head to another; has a burning pressure sensation in his head; fever; elevated heart rate; headache after second dose; experienced arm pain; arm soreness; This is a spontaneous report from a contactable consumer. A 48-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in left arm on 20Feb2021 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. Medical history included eczema, psoriasis, neuropathy peripheral feet. The patient's concomitant medications were not reported. The patient previously took amoxicillin, bnt162b2, 1st dose, Batch/lot number: EL9264 for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received various vitamins within 2 weeks of vaccination. Caller reported adverse events following his second dose of the Pfizer COVID-19 vaccine. He had the second dose of the vaccine on 20Feb2021. He said that he has a burning pressure sensation in his head and it is still ongoing. He said the pain can move from one place on his head to another. He wanted to know if that has been reported as an adverse event for the Pfizer COVID-19 vaccine (immediate and long term). He added that he never experienced anything like it. He said that he did not have any lifestyle change, no diet change, and no change in supplements. There were no other notable patterns or numerical imbalances between treatment groups for specific categories of serious adverse events (including neurologic, neuro-inflammatory, and thrombotic events) that would suggest a causal relationship to Pfizer-BioNTech COVID-19 Vaccine. The patient experienced cranial pressure/ burning sensation in forehead accompanied by headache pain in forehead and other areas of head with varying degrees of intensity starting approximately a week after the second vaccination. For the past 11 weeks the symptoms have been constant with varying levels of intensity. The adverse event result in doctor or other healthcare professional office/clinic. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced cranial pressure on 27Feb2021 with outcome of not recovered, has a burning pressure sensation in his head/ cranial pressure/ burning sensation in forehead on 27Feb2021 with outcome of not recovered, the pain can move from one place on his head to another on 27Feb2021 with outcome of not recovered, has a burning pressure sensation in his head on 27Feb2021 with outcome of not recovered, experienced arm pain on 20Feb2021 with outcome of recovered, fever on 21Feb2021 with outcome of recovered, elevated heart rate on 21Feb2021 with outcome of recovered, arm soreness on 30Jan2021 with outcome of recovered, bad headache after second dose on 20Feb2021 with outcome of recovered. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 14May2021. Information on Lot/Batch number was available. Additional information has been requested.
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| 48 | 2021-06-05 | involuntary muscle movements |
This is a follow up to a previously filed report.... Conditions continue to worsen. Swollen gland in...
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This is a follow up to a previously filed report.... Conditions continue to worsen. Swollen gland in neck continues, I've begun having fevers (days 16-17 after second vaccine shot), loss of appetite, difficulty opening mouth because something is now going on on my right jaw/ear area. Also, I'm not developing small skin infections on both hands and those are being treated by a dermatologist with topical antibiotic.
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| 48 | 2021-06-07 | numbness |
Severe pain in right lower back; Severe pain in right lower back; traveled to lower right abdomen; I...
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Severe pain in right lower back; Severe pain in right lower back; traveled to lower right abdomen; It left a numb feeling behind; The caller thinks he has a rare case of shingles happening; Slight swelling on right side; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 at the age of 48-year-old, via an unspecified route of administration, administered in left deltoid on 23Apr2021 (Lot Number: EW0171; Expiration Date: 31Aug2021) as 1st dose, single dose for COVID-19 immunisation. Medical history included chronic lymphocytic leukaemia from 2021 and ongoing (states he was diagnosed about 2 months ago) and had shingles once already when he was 20 years old. The patient's concomitant medications were not reported. The patient stated that he had the first dose of the vaccine on 23Apr2021. The patient experienced severe pain in his right lower back on 23Apr2021. He spent 24Apr2021, 25Apr2021, and 26Apr2021 at the hospital in the Emergency Room getting treated for severe pain in his right lower back. He states they ran all kinds of tests, but they could not figure out what was going on. States he was not admitted to the hospital during that time; he was treated for severe pain in his right lower back in the Emergency Room. The patient mentions that his wife also had the vaccine and she had a sore arm and some body soreness, but she wasn't sick or anything like that. He states he was still recovering from severe pain in his right lower back. The pain migrated from his back around to the lower right side of his abdomen on Apr2021. States that it left a numb feeling behind on Apr2021. The patient stated that after reading and after seeing 5 doctors; the patient told his oncologist that he thinks he has a rare case of shingles happening on Apr2021. He thinks it was the very rare kind where you don't have a rash appear. He had shingles once already when he was 20 years old. This time he thinks that was what it was again with no rash, just pain and discomfort. The severe pain in his right lower back was much better than it was. Says his skin looks normal. There was some slight swelling on his right side on Apr2021. The patient states that when it was time for his second dose of the vaccine, he hadn't recovered from the first dose. He did not go get his second dose; states his doctor agreed with that decision. Severe pain in right lower back, traveled to lower right abdomen resulted in emergency room and physician office visit. The patient underwent lab tests and procedures on Apr2021 which included CT scan (they were checking his lymphatic system), MRI and Ultrasound were done at the Emergency Room. The patient stated they found nothing on these tests. The outcome of the event low back pain was recovering and for the rest of the events was unknown.
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| 48 | 2021-06-07 | numbness | Numbness left foot |
| 48 | 2021-06-09 | cold sweat |
Heart attack in right carotid artery. Severe chest pain, shortness of breath, clammy, sweat for abou...
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Heart attack in right carotid artery. Severe chest pain, shortness of breath, clammy, sweat for about 45 minutes. Then irregular heart beat and significantly high blood pressure (over 190). Stent put in.
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| 48 | 2021-06-09 | pain in extremity |
Swollen inner checks; Extreme arm pain; Fatigue; This is a spontaneous report from a contactable con...
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Swollen inner checks; Extreme arm pain; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number and expiration date not reported), via an unspecified route of administration on 11Mar2021 13:00 (at the age of 48-years-old) at 1st dose, single dose in the left arm for COVID-19 immunization. The patient's medical history and concomitant medications were reported as none. The patient has no allergies to medications, foods, or other products. On 11Mar2021 23:00, the patient experienced swollen inner cheeks, extreme arm pain, and fatigue. The patient did not receive any treatment for the events. It was reported that the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, did not receive any other medications within 2 weeks of vaccination, has not been diagnosed with COVID-19 prior to vaccination, and has not been tested for COVID-19 since the vaccination. Outcome of all the events was reported as recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 48 | 2021-06-10 | bell's palsy, numbness, facial paralysis |
I experienced facial numbness and paralysis. As per Doctor it's Bell's Palsy; I experienced facial n...
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I experienced facial numbness and paralysis. As per Doctor it's Bell's Palsy; I experienced facial numbness and paralysis. As per Doctor it's Bell's Palsy; I experienced facial numbness and paralysis. As per Doctor it's Bell's Palsy; This is a spontaneous report from a contactable consumer (patient). A 48-years-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0176), via an unspecified route on 03May2021 at 14:30 (at the age of 48-years) as 2nd dose, single dose in the left arm for covid-19 immunisation. The patient medical history included chronic lymphocytic leukaemia. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. It was unknown prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included rivaroxaban (XARELTO). The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0151), via an unspecified route on Apr2021 at 14:30 as 1st dose, single dose in the left arm for covid-19 immunisation. On 28May2021, the patient experienced facial numbness and Paralysis. As per doctor it's bell's Palsy. The patient received treatment for events with prednisone and valacyclovir. The patient visited physician office. The outcome of the events was not recovered. Follow-up attempts are needed. Further information is requested.
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| 49 | 2021-01-03 | tingling |
Approximately 4 days after vaccine I started experiencing sharp lower back and left hip pain. Also m...
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Approximately 4 days after vaccine I started experiencing sharp lower back and left hip pain. Also my left foot feels like pins and needles.
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| 49 | 2021-01-05 | discomfort |
The body aches started in his shoulder and now are all over his neck, back and whole body aches; The...
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The body aches started in his shoulder and now are all over his neck, back and whole body aches; The body aches started in his shoulder and now are all over his neck, back and whole body aches/ feeling like he has 1,000 pounds on his back; The body aches started in his shoulder and now are all over his neck, back and whole body aches; Body aches/The body aches started in his shoulder and now are all over his neck, back and whole body aches; Headache; Chills; Feel like crap; Low grade temperature; This is a spontaneous report from a contactable Nurse (patient). A 49-year-old male patient received BNT162B2 (Pfizer-BioNTech Covid-19 vaccine, lot number EL0142) intramuscularly at right shoulder approximately at 17:30 on 29Dec2020 for Covid-19 immunization. The patient's medical history included diagnosed allergies, compromised immune status, respiratory illness, genetic / chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity (a little over weight but he is fit). The patient had COVID in the end of Apr2020. The patient had no family medical history and had no prior vaccinations within four weeks. The patient had no concomitant medication. The second day of the vaccination, the patient called to report body aches, headache, chills, low grade temperature. As he reported, he just woke up and was walking around feeling like he had 1000 pounds on his back and felt like crap. The body aches started in his shoulder and currently all over his neck, back and whole body aches. Chills started last night (vaccination night). He was just trying to get to sleep and had to put an extra sweatshirt on last night. He did not check his temperature until he got up and it was 99.2 degrees Fahrenheit. He was not able to provide a start date for the temperature. "Body aches, headache between, chills between, low grade temperature (unspecified start date), feels like crap" were considered developing between 24:00-01:00. He stated that they were all medically significant and he needs a day to recover hopefully. He just felt like he was hit by a truck. The patient had not visited physician or went to ER yet. The outcome of low grade temperature was unknown, chills was resolving and all other events did not resolve at the time of reporting.; Sender's Comments: There is a reasonable possibility that the events vaccination site pain, headache, chills, and pyrexia were related to BNT162b2 based on known drug safety profile. The association between the other reported events with BNT162b2 can not be completely excluded based on temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 49 | 2021-01-05 | flushing |
Fever, feeling flushed, tunnel vision, light headedness, headache/pressure, chills, elevated pulse r...
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Fever, feeling flushed, tunnel vision, light headedness, headache/pressure, chills, elevated pulse rate, elevated blood pressure. Took migraine medication for headache, outcome unknown
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| 49 | 2021-01-05 | numbness |
after 5 minutes states her fingers felt weird -numb and felt like her hear was racing, very anxious ...
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after 5 minutes states her fingers felt weird -numb and felt like her hear was racing, very anxious started to hyperventilate. Took her to ER via WC . During transfer stated her fingers were twisting (noticed definite contractures in both hands. States her heart was beating very fast. Denies any allergies but did states she has history of low potassium and has had issues with medications nad vaccines in the past. However no sx like this but does get "a little loopy" even when taking motrin. Instructed her to notify any provider prior to any vaccinations of the above sx. If I would have know any off this I would have highly recommended her to get authorization from her PCP prior
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| 49 | 2021-01-05 | pain in extremity |
SkinRash Sore arm Narrative: Redness about the size of a quarter on left hand, sore arm day after i...
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SkinRash Sore arm Narrative: Redness about the size of a quarter on left hand, sore arm day after injection
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| 49 | 2021-01-06 | difficulty speaking |
moderate injection site pain and swelling, fatigue after 1 day from vaccination, day 2 from vaccinat...
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moderate injection site pain and swelling, fatigue after 1 day from vaccination, day 2 from vaccination developed unwell feeling and congestion, scratchy voice, and worsening fatigue
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| 49 | 2021-01-06 | tremor |
Had a slight headache a few hours after the injection, three hours later felt tired and headache wor...
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Had a slight headache a few hours after the injection, three hours later felt tired and headache worsened but improved with 500mg Tylenol. That night fatigue got worse but headache improved. Went to bed at 9pm and had severe chills and shaking, heart was beating fast. Chills lasted for several hours. Increased heart rate all night and could not sleep at all. Fitful night sleep and started to sweat in the Early morning. Woke up for work at 5:30 am and had headache, dizziness, and flu-like symptoms with joint and muscle aches. Had sweats all day today. Went home early from work and slept from 9:30 am to 4:30 pm. Most symptoms improved now but feel like I still have a fever and sweats.
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| 49 | 2021-01-07 | flushing, pain in extremity, tremor |
approximately 5" after receiving injection, headache developed. Progressively got worse within 30",...
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approximately 5" after receiving injection, headache developed. Progressively got worse within 30", rated 6/10. described as "felt like the Hulk was squeezing the back of my neck". Returned back to CVCU and coworkers commented on how red he looked- "face and arms were red like he had just ran a marathon, but not blotchy or rash". HIs entire arm began hurting and has been hurting and waking him up every night and needing repositioned several times throughout the night. L arm shakes/tremors, constantly - described incident where he was holding a plate at home a few days after injection and his left arm involuntary shook, uncrontrollably.
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| 49 | 2021-01-08 | numbness, tingling |
Headache tingling and numbness in R side down to toe's then whole body, HA on R side, felt better af...
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Headache tingling and numbness in R side down to toe's then whole body, HA on R side, felt better after standing up. stayed 30 minutes. Felt better and left. Narrative:
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| 49 | 2021-01-09 | tremor |
RECEIVED DOSE AT 1;17 pm 1/7/2021. At 9pm 1/7/2021, muscle aches, fatigue, fever (100.4F) and shakin...
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RECEIVED DOSE AT 1;17 pm 1/7/2021. At 9pm 1/7/2021, muscle aches, fatigue, fever (100.4F) and shaking chills began. waxed and waned throughout 01/08/2021 and finally ended approximately 05:00 Saturday 01/09/2021. I have felt totally fine since then. I received the first dose 12/17/2020 in my left arm at 1230pm. I had no side effects except for paining some swelling in the deltoid muscle that lasted a day or so. I get the full vaccine every year and never have any sort of reaction, even a mild one. I am a physician and understand the purpose of the vaccine and how it works.
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| 49 | 2021-01-10 | tingling |
Vaccine given at 07:50 (AM), with no immediate concerns. Within 4-6 hours, soreness at injection sit...
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Vaccine given at 07:50 (AM), with no immediate concerns. Within 4-6 hours, soreness at injection site was noted (soreness took 12-18 hours to start after first dose) By 8 hours after vaccination, had generalized "tingling" like a flu prodrome. By 12 hours after vaccination, experienced generalized aches, chills, mild headache and ipsilateral axillary lymphadenitis All symptoms persisted for 48 hours before resolution, except for axillary lymph node pain. Axillary lymphadenitis persisting , but resolving, by 72 hours after vaccination.
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| 49 | 2021-01-11 | numbness, pain in extremity |
Approximately 24 hours post shot I experienced severe joint pain in most all joints. Shortly after ...
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Approximately 24 hours post shot I experienced severe joint pain in most all joints. Shortly after onset of joint pain experienced severe chills. Those symptoms persisted for approximately 12 hours after which I continued to experience injection site pain, but began to experience pain with some numbness that radiated from the injection site distally down my arm and into my pinky and ring fingers on my left hand. No other symptoms. As of today the injection site pain persists as does the pain and numbness in my pinky and ring fingers, but I get the feeling that it is getting slightly worse. The pain and slight numbness is present when I awake, but gets worse throughout the day. Some evenings there is considerable discomfort.
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| 49 | 2021-01-11 | pain in extremity |
Arm soreness; This is a spontaneous report from a contactable physician. A 49-year-old male patient ...
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Arm soreness; This is a spontaneous report from a contactable physician. A 49-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number EK9231), via an unspecified route of administration on 19Dec2020 08:00 at single dose at right arm for COVID-19 immunization. Medical history included asthma. Concomitant medications included budesonide (PULMICORT), mometasone furoate (NASONEX), ibuprofen, and paracetamol (TYLENOL). On 20Dec2020, the patient experienced arm soreness. The patient did not receive treatment for the event. The outcome of the event was recovered.
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| 49 | 2021-01-12 | numbness | Systemic: LLE numbness |
| 49 | 2021-01-13 | bell's palsy |
Was working on a shower door and i got dizzy, called my wife (She's a RN) because i didn't feel good...
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Was working on a shower door and i got dizzy, called my wife (She's a RN) because i didn't feel good. She came in and said it looked like i had a stroke. She called 911 and i was taken to ER
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| 49 | 2021-01-14 | weakness, pain in extremity |
prominent lower axillary swelling same side as shoulder injection site; Flu-like symptoms; soreness ...
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prominent lower axillary swelling same side as shoulder injection site; Flu-like symptoms; soreness (other than injection areas including thighs); soreness (other than injection areas including thighs); more severe soreness/generalized soreness (other than injection areas including thighs); more severe soreness including back of shoulder; generalized weakness; This is a spontaneous report from a contactable physician (patient himself). A 49-year-old male patient received a second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231; expiry date: unknown) via an unspecified route of administration (right arm), on an unspecified date, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received chlorhexidine and propylene glycol and experienced allergies. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date unknown) in the left arm on 17Dec2020 at 17:30 for COVID-19 immunization. On 08Jan2021, the patient experienced more severe soreness including back of shoulder, generalized weakness, and generalized soreness (other than injection areas including thighs) beginning at 13:00 following day lasting the rest of the day. On an unspecified date, the patient also had prominent lower axillary swelling same side as shoulder injection site, flu-like symptoms, and focal soreness. The patient received over the counter (OTC) Motrin as treatment for the events. The patient recovered from flu-like symptoms, but has not yet recovered from the remaining events.
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| 49 | 2021-01-14 | pain in extremity |
Arm pain; Injection site pain; Fever; Chills; Nausea; Headache; Body aches; General malaise; This is...
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Arm pain; Injection site pain; Fever; Chills; Nausea; Headache; Body aches; General malaise; This is a spontaneous report from a contactable nurse, the patient. This 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL9231 ), dose 2 , single dose via an unspecified route of administration in the left arm on 07Jan2021 at 07:30 AM (at the age of 49 years-old) for COVID-19 vaccination. Relevant medical history included high cholesterol. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL0140,), single dose, dose 1 in the left arm on 18Dec2020 at 09:30 AM. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included aspirin, rosuvastatin (CRESTOR), D3, zinc and multivitamin. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 07Jan2021 at 10:00 PM, the patient experienced arm pain, injection site pain, fever, chills, nausea, headache, body aches and general malaise. The report was reported as non-serious. The patient was not treated for arm pain, injection site pain, fever, chills, nausea, headache, body aches and general malaise. The clinical outcome of arm pain, injection site pain, fever, chills, nausea, headache, body aches and general malaise was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 49 | 2021-01-15 | muscle spasms | Muscle Spas; Weakness in both limbs. Pressured speech |
| 49 | 2021-01-15 | pain in extremity |
12 hours after injection, noticed l mild right arm soreness, along with fatigue and chills. 18 hour...
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12 hours after injection, noticed l mild right arm soreness, along with fatigue and chills. 18 hours after injections, body aches, joint (back and hips mostly) pain, and severe chills. Low grade 100.4 F fever and malaise / fatigue. Symptoms all resolved, except mild fatigue, after 24 hours
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| 49 | 2021-01-17 | cold sweat | Chest tightness, Chills, Dizziness, 'cold sweats' |
| 49 | 2021-01-18 | burning sensation |
Vasculitis of hands and feet. Symptoms first noted in hands on 1/17/2021 - intermittent - adverse re...
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Vasculitis of hands and feet. Symptoms first noted in hands on 1/17/2021 - intermittent - adverse reaction on 1/18/2021 at 11:08 pm - hands became bright red as well as feet. Burning sensation (similar to taking Niacin) Color changed in feet from bright red to dark red with some purple in digits 2 and 3 of both feet. Appears swollen. I was informed on 1/12 (4 days after being vaccinated) that my daughter had been exposed to COVID. We family quarantined. The adverse reaction led me to go to an urgent care clinic to be tested for COVID. I had the POC test performed and came back positive. My temperature was recorded at 99.3 F.
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| 49 | 2021-01-18 | migraine |
slight headache and muscle ache, during the evening it progressed to extreme chills, achiness, heada...
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slight headache and muscle ache, during the evening it progressed to extreme chills, achiness, headache off the charts; slight headache and muscle ache, during the evening it progressed to extreme chills, achiness, headache off the charts; slight headache and muscle ache, during the evening it progressed to extreme chills, achiness, headache off the charts; joint pain in elbows; extreme chills; migraine was at a level of intractable pain; maybe a low grade fever of 99F; This is a spontaneous report from a contactable other hcp (Anesthesiology, patient). A 49-years-old male patient received second dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine), via an unspecified route of administration on 07Jan2021 08:30 at SINGLE DOSE for covid-19 immunisation. Medical history included migraines headaches. This was migraine plus; extreme pain which he took migraine pain medicine. The patient's concomitant medications were not reported. The patient previous received 1st dose of bnt162b2.The other HCP reported: On Thursday 07Jan2021, he received the 2nd shot at 8:30am, then about 3-4pm he had symptoms of slight headache and muscle ache, during the evening it progressed to extreme chills, achiness, headache off the charts. Throughout the evening into the next day, he suffered chills that went away, joint pain in elbows; headache pain, which he had to do migraine medicine again. Saturday morning he felt better, he don't have a headache, but for a good 36 hours, migraine was at a level of intractable pain since Jan2021. He never had a fever, well maybe a low grade fever of 99F in Jan2021. The even outcome of chills was recovered Jan2021, headache was recvoered on 09Jan2021; outcome of other events were unknown. Information on the lot/batch number has been requested.
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| 49 | 2021-01-19 | feeling of body temperature change | Exhausted and cold then hot. |
| 49 | 2021-01-19 | pain in extremity | Achy left arm and left armpit resulting in me taking Ibuprofen. (Took 3 -400mg pills over 12hrs) |
| 49 | 2021-01-21 | pain in extremity |
First injection in left arm, Head ache lasting for 4 Days, arm sore for 5 Days. Second injection a...
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First injection in left arm, Head ache lasting for 4 Days, arm sore for 5 Days. Second injection after an hour tingling in left side of lip and pain in the left jaw joint. Head ache still persistant. Tingling went away after 6 HR and pain in jaw joint stopped.
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| 49 | 2021-01-22 | tremor |
Monday, 1/18: Extremely tired., shaky, diarrhea 4 times, legs very week and heavy feeling like I was...
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Monday, 1/18: Extremely tired., shaky, diarrhea 4 times, legs very week and heavy feeling like I was walking with cinder blocks on my feet. Tuesday 1/19 : Very tired, no bowel movement (took imodium AD 1/18) ,legs very painful after sitting and the pain was generally from knee to hip. Movement helped alleviate the pain. Tired/shaky feeling increased throughout the day. Wednesday 1/20: Same symptoms as 1/18 AND a sensation of pins and needles all over my body. It would randomly come and go from literally every area of my body and this was so pronounced it was hard to fall asleep that night. Thur 1/21. Leg pain gone but still week and tired. Pins and needles sensation better but not gone. Friday 1/22 same as 1/21 Saturday 1/21 same as 1/21. Tried to do a little work around the house and was exhausted. Pins and needle sensation remains the same.
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| 49 | 2021-01-24 | pain in extremity |
On 1/18/2021, at approximately 02:00 AM, I woke up with extreme pain in my right arm. The pain radia...
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On 1/18/2021, at approximately 02:00 AM, I woke up with extreme pain in my right arm. The pain radiates from the shoulder/bicep down to the forearm. The pain did not subside until later in the evening. I continued to have discomfort and pain on and off throughout the week. On 1/25/2021, I again woke up with extreme pain in my right arm. I have tried ibuprofen and different arm positions to reduce the pain and discomfort without any luck. The arm is tender/sore. I am not sure if this is a reaction to the vaccine or if the needle protruded too far when administered. I have an MRI scheduled to rule out any type of injury.
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| 49 | 2021-01-25 | tension headache |
2nd dose had fatigue; mild fever; body ache; tension headache; This is a spontaneous report from a c...
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2nd dose had fatigue; mild fever; body ache; tension headache; This is a spontaneous report from a contactable nurse reported for himself. A 49-year-old male patient received second dose of bnt162b2 (BNT162B2, Lot#: EJ1686), via an unspecified route of administration on 11Jan2021 on Right Arm at single dose for covid-19 immunisation. Medical history included Ulcerative Colitis. No allergies to medications, food, or other products. Concomitant medications included the patient received within 2 weeks of vaccination: Mesalamine. The patient previously took first dose of bnt162b2 (Lot#: EH9899) via Intramuscular on 21Dec2020 09:30 AM on Left arm at single dose for covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced 2nd dose had fatigue, mild fever, body ache and tension headache from 12Jan2021 06:00 AM. The outcome of the events was recovered. No treatment was received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Location of injection information is available for all vaccines received on the same date.
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| 49 | 2021-01-26 | feeling hot |
Raised, hot, red rash at right knee, bilateral elbows, and midback. Itchiness was 8/10 itchy per pa...
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Raised, hot, red rash at right knee, bilateral elbows, and midback. Itchiness was 8/10 itchy per patient.
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| 49 | 2021-01-26 | muscle spasms, weakness, tremor |
Pressured Speech; Weakness and tremors to both limbs; Weakness and tremors to both limbs; muscle spa...
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Pressured Speech; Weakness and tremors to both limbs; Weakness and tremors to both limbs; muscle spasm; This is a spontaneous report from a contactable Other HCP (patient). This 49-year-old male patient received his first dose of intramuscular BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 28Dec202 at 17:30 in left arm at single dose for COVID-19 immunisation at the age of 49-year-old. Lot number was EK9231. Medical history included gout. Concomitant medications were unknown. On 10Jan2021, the patient experienced Pressured Speech, weakness and tremors to both limbs and muscle spasm. The events resulted in Emergency room/ department or urgent care and Hospitalization for one day. The patient was not treated for the events. COVID was tested post vaccination on 13Jan2021, Nasal Swab, polymerase chain reaction (PCR) and it resulted negative. The patient did not recover from the events.; Sender's Comments: The events pressured speech, weakness and tremors to both limbs ,muscle spasm are less likely related to suspect BNT162B2 administration given the weak time association. The available examination results would be helpful for further assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 49 | 2021-01-27 | pain in extremity | sore arm |
| 49 | 2021-01-28 | pain in extremity |
Mild arm tenderness; This is a spontaneous report from a contactable pharmacist reported that a 49-y...
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Mild arm tenderness; This is a spontaneous report from a contactable pharmacist reported that a 49-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular on the left arm on 17Dec2020 09:00 at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced mild arm tenderness on an unspecified date with outcome of recovered. No treatment received for the reported event.
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| 49 | 2021-02-01 | facial paralysis |
Diagnosis of Bell's palsy/ getting peripheral nerve palsy/Left side partial facial paralysis/droopy ...
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Diagnosis of Bell's palsy/ getting peripheral nerve palsy/Left side partial facial paralysis/droopy face; difficulty with blinking; This is a spontaneous report from a non-contactable consumer. A 49-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number EL3246), via an unspecified route of administration on 09Jan2021 14:30 at left arm at single dose for covid-19 immunisation. Medical history included type 2 diabetes, Hep B carrier. Concomitant medication included metformin, entecavir. On 17Jan2021 04:30 PM, the patient experienced left side partial facial paralysis, droopy face, difficulty with blinking...went to ER to rule out stroke, MRI and CAT scan normal. Diagnosis of Bell's palsy. First time getting peripheral nerve palsy. AE treatment: Prednisone, Valtrex, eye drops...IV steroids. No covid prior vaccination. No covid tested post vaccination. No other vaccine in four weeks. No known allergies. The patient underwent lab tests and procedures which included computerised tomogram: normal, magnetic resonance imaging: normal. The outcome of the events was not resolved. No follow-up attempts are possible. No further information is expected.
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| 49 | 2021-02-02 | tenderness |
Bump and red rash around it. Started night after second shot. Still theren48 hours later. Painful...
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Bump and red rash around it. Started night after second shot. Still theren48 hours later. Painful to touch.
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| 49 | 2021-02-03 | pain in extremity |
arm pain; fatigue; This is a spontaneous report from a contactable consumer (patient himself). A 49-...
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arm pain; fatigue; This is a spontaneous report from a contactable consumer (patient himself). A 49-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730, expiry date not reported), via an unspecified route of administration on 21Dec2020 07:30 at single dose for COVID-19 immunization. Medical history included seasonal allergy and mild jackfruit allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included finasteride and testosterone. The patient experienced arm pain and fatigue on an unspecified date. Clinical outcome of the events was unknown.
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| 49 | 2021-02-04 | pain in extremity |
Extreme fatigue; Heavy and achy legs; Heavy and achy legs; Headache; No appetite; Nausea; Lethargic;...
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Extreme fatigue; Heavy and achy legs; Heavy and achy legs; Headache; No appetite; Nausea; Lethargic; Injection site pain; This is a spontaneous report received from a contactable consumer (patient). A 49-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration in the left arm, on 16Jan2021 17:15, at single dose, for COVID-19 immunization, at the hospital. There were no medical history and no known allergies. The patient did not have COVID-19 prior to vaccination. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL). The patient did not receive other vaccines in four weeks. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, expiry date unknown), via an unspecified route of administration in the left arm, on 28Dec2020 16:45, for COVID-19 immunization. The patient did not test for COVID-19 post vaccination. On 17Jan2021 at 08:00, the patient experienced extreme fatigue, heavy and achy legs, headache, no appetite, nausea, lethargic and injection site pain. No treatment was provided for the events. The outcome of the events was resolved on an unspecified date.
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| 49 | 2021-02-04 | pain in extremity |
arm pain; fatigue; beginning 1/13 a constant high pitch whine in whole head; probably tinnitus; This...
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arm pain; fatigue; beginning 1/13 a constant high pitch whine in whole head; probably tinnitus; This is a spontaneous report from a contactable consumer (patient). A 49-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3246; expiry date: unknown) via an unspecified route of administration in the left arm, on 11Jan2021 at 07:30, at a single dose, for COVID-19 immunization. Medical history included seasonal allergies and mild jackfruit allergy. Concomitant medications included testosterone, finasteride, and unspecified vitamins. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK5730; expiry date: unknown) on 21Dec2020, at 07:30 AM, in the left arm, for COVID-19 immunization and experienced arm pain and fatigue. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. On an unspecified date, the patient had arm pain and fatigue from second dose but milder. On 13Jan2021, at 07:00 AM, the patient experienced a constant high pitch whine in whole head, probably tinnitus. The patient has not sought medical attention yet. The events were considered non-serious. Outcome of the events "beginning 1/13 a constant high pitch whine in whole head" and tinnitus was not recovered, while outcome of the other events was unknown. The patient has not been tested for COVID-19 since vaccination.
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| 49 | 2021-02-04 | tingling | Mild Tingling, Shortness of Breath and stuttering |
| 49 | 2021-02-07 | facial paralysis |
Peripheral facial paralysis (Bell's Palsy) left side 8 days after vaccination; This is a spontaneous...
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Peripheral facial paralysis (Bell's Palsy) left side 8 days after vaccination; This is a spontaneous report from a contactable 49-year-old male other healthcare professional (HCP) (patient) reported for himself received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246) via unspecified route on left arm single dose for COVID-19 immunization on 09Jan2021, 02:30 PM, at 49-year-old. Medical history included: Borderline Type 2 diabetes; Hepatitis B carrier. No allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included: metformin, entecavir. The patient did not receive any other vaccines within 4 weeks prior to the BNT162B2. The patient had peripheral facial paralysis (Bell's Palsy) left side 8 days after vaccination (17Jan2021) and was reported as non-serious. Treatment was received as steroids and antiviral. Emergency room/department or urgent care visited. Since the vaccination, the patient had not been tested for COVID-19. Action taken for BNT162B2 was not applicable. Outcome of the event was not resolved.; Sender's Comments: Based on currently known drug safety profile, a causal association between the reported event peripheral facial paralysis and BNT162B2 cannot be fully excluded. The event facial paralysis can also be caused by other virus infection. Case will be reassessed when additional information is available including viral testing. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and investigators, as appropriate.
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| 49 | 2021-02-11 | feeling hot, feeling cold |
Got the does on the 6th of January around 3:00pm Around 9a on the 7th my skin started to hurt the...
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Got the does on the 6th of January around 3:00pm Around 9a on the 7th my skin started to hurt then about about 9:00PM I developed chills Around 2 am the next day I woke up really hot also with chills 5AM 8th I noticed a 10cm soft lump on the left arm pit 22nd Completely resolved
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| 49 | 2021-02-13 | pain in extremity |
I am a physician who received the second Pfizer COVID-19 vaccine in my right arm on 1-13-21. On 1-14...
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I am a physician who received the second Pfizer COVID-19 vaccine in my right arm on 1-13-21. On 1-14-21 I developed deep aching right sided neck pain distinct from the injection site pain, and this progressed to right cervical radiculopathy, with 12-15 hours of radicular pain radiating from my right neck through my right hand. The best way to describe this is it felt like a tooth ache from my neck to my hand. That is not why I'm writing. I'm writing because around 2-9-2021 I developed a pruritic rash near my right wrist that I originally thought was contact dermatitis, but I could not recall the initial contact. The rash persisted, and 2-13-21 it spread, began to crust, and started burning, consistent with shingles in the C8 distribution. I'm a 49 year old quacks-like-a-duck doctor, and wanted to share my story due to the possible connection between the Pfizer mRNA vaccine and herpes zoster.
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| 49 | 2021-02-15 | tremor, pain in extremity |
1/6/2021 vaccination; Later that afternoon, I started to go into a 'fog', tired, HA. I could functi...
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1/6/2021 vaccination; Later that afternoon, I started to go into a 'fog', tired, HA. I could function but nothing seemed 'clear' or 'sharp', 1/7/2021 fatigue, arm sore. The 'fog' was worse; 1/8 fog was really bad; forgetting conversations. 1/9 2:45 in morning. Went to bathroom. Walking, about 1/2 way there, felt like a 'spike' and instant HA. I went to bathroom, door closed, I got sick/vomiting. The shiver, shakes, and fever spiked. I bent down to throw up and I cant relieve. I fell into the wall, pushed self to stand up. Was back in bedroom, laying on floor and passed out. Wife woke me, I was bleeding. Don't know how long I was on the floor. BP144/78, 133 blood sugar, O2 was 98%, temp 98.1. 3:45 I decided to go to hospital, EKG, CT scan, Xray, etc. 'Just fainted' *PCP stated it was due to shot / vaccine. **busted lip, ER bill ***2nd vaccine; minor side affects (slight HA, )
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| 49 | 2021-02-16 | weakness | FEVER, DIARRHEA, HEADACHE, WEAKENESS, MILS ABDOMINAL DISCONFORT |
| 49 | 2021-02-22 | bell's palsy | Patient developed R sided Bell's Palsy approximately 10 days after vaccination |
| 49 | 2021-02-25 | muscle spasms |
1/22 ? Received second dose of vaccine 1/23-1/25 ? started having LLQ abdominal, flank, and back pai...
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1/22 ? Received second dose of vaccine 1/23-1/25 ? started having LLQ abdominal, flank, and back pain. The pain was isolated, sharp in nature and rated 7/10. No rash or blistering in the area. 1/25 ? Contacted primary care physician and referred to medical facility for work up. Ruled out kidney stone. Abdominal CT scan negative. Treated with Torodal and Dilaudid with minimal relief. Discharged dx of muscle spasm and rx for muscle relaxants. 1/26 ? Follow up appointment with primary care physician. Added NSAIDS for ongoing pain. 1/27 ? Represented to ETC for ongoing LLQ abdominal, flank, and back pain. Noted constipation. KUB(kidney, ureter, and bladder) showed ileus. 1/28 ? Follow up appointment with primary care physician. Started on gabapentin 100mg TID for ongoing pain. 2/3 ? LL abdominal bulge noted (16cm x 10cm). Contacted primary care physician and referred back to hospital. Repeat KUB(kidney, ureter, and bladder) and CT scan are negative. 2/4 ? Follow up appointment with primary care physician. MRI of lumbar spine ordered. 2/10 ? Appointment with colorectal surgeon. Appreciated continued bulge. Recommended follow up appointment with hernia surgeon. 2/11 ? Appointment with hernia surgeon. Noted that the bulge decompresses when laying flat. Abdominal ultrasound ordered to rule out spigelian hernia. 2/12 ? Ultrasound negative for any kind of defect. Lumbar MRI performed. 2/17 ? follow up appointment with hernia surgeon. Based upon everything they believe that this is a pseudohernia likely caused by the COVID vaccine and possible irritation of HZ virus. Continued to not show any rash or blistering. Continue with gabapentin and added acyclovir."
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| 49 | 2021-02-26 | tingling, numbness |
Reaction started approximately 10 hours post-vaccination and included loss of vision in left eye, nu...
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Reaction started approximately 10 hours post-vaccination and included loss of vision in left eye, numbness and tingling on right side (arm, legs), numbness of tongue, pain in all joints including knees, shoulders, neck, ankles and arms/elbows.
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| 49 | 2021-02-28 | weakness |
Injection site pain-minimal Tiredness- 3days, low energy Headache-severe for over 3 days Nausea- mil...
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Injection site pain-minimal Tiredness- 3days, low energy Headache-severe for over 3 days Nausea- mild, 2 days Difficulty breathing- on two separate occasions after minimal activity
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| 49 | 2021-02-28 | bell's palsy, numbness |
Feb 15, 2021 Monday, I started feeling pain on the right portion of my neck; Feb 16, 2021 Tuesday, I...
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Feb 15, 2021 Monday, I started feeling pain on the right portion of my neck; Feb 16, 2021 Tuesday, I felt the pain radiating inside my right ear and had a mild headache. Tuesday evening, my wife noticed that I am not fully blinking/closing my right eye; Feb 17, 2021 Wednesday, I didn't have the same pain but there's numbness on my right cheek extending to my right lips. Wednesday afternoon around 2pm, I went to my dentist thinking it was due to my Invisalign which I started on Jan 25, 2021. The dentist told me it is most likely Bell's palsy so I decided to go to Emergency.
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| 49 | 2021-03-01 | weakness, one side paralysis, sensory loss |
Decreased sensation from chest/abdomen through lower extremities, diminished strength and mobility ...
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Decreased sensation from chest/abdomen through lower extremities, diminished strength and mobility of left side. Symptoms started approximately 24 hours after receiving the vaccine starting with decreased sensation in the lower extremities . 02/14/2021 I started experiencing weakness on the left side. 02/16/2021 symptoms progressed to limited movement on the left side preventing ability perform normal daily functions and digestion was effected.
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| 49 | 2021-03-01 | pain in extremity |
Early Wednesday morning (2/24) around 5:00AM, I woke up to extreme pain in my left arm, primarily al...
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Early Wednesday morning (2/24) around 5:00AM, I woke up to extreme pain in my left arm, primarily along the upper forearm, inside of my elbow, and lower bicep. There was no trauma or unusual behavior prior to onset of pain. It came on suddenly and worsened with extension of the arm. Symptoms worsened over the next few days, with pain intensifying and extending down into my hand and up into my armpit and shoulder. I tried ice, Ibuprofen, Acetaminophen, and Vicodin for pain relief, but nothing really helped other than the ice. On Saturday morning (2/27), I visited Urgent Care and was diagnosed as brachial plexis neuritis, aka Parsonage-Turner Syndrome by Dr and prescribed Prednisone and rest. On Sunday evening (2/28), I went to the ER seeking pain relief and second opinion. On Monday (3/1) morning, I was seen by ED doctors, and then three different neurologists. After doing an ultrasound which ruled out vein/artery thrombosis, the neuro team diagnosed Parsonage-Turner Syndrome. They've prescribed Gabapentin, Acetaminophen, and Ibuprofen for pain relief, a follow-up neuro consult, an MRI for next Friday, and an EMG in a few weeks. Last night while sitting and reading, the same pain began in my right arm, similarly to how it presented in my left arm last week. The right arm pain is less than the left arm pain, but at this point seven days later, I am experiencing neuropathic pain in both arms.
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| 49 | 2021-03-04 | pain in extremity |
Bitter metallic taste in my mouth; fatigue; arm soreness; lip tingling; headache; This is a spontane...
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Bitter metallic taste in my mouth; fatigue; arm soreness; lip tingling; headache; This is a spontaneous report from a contactable consumer (patient). This 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EL9262) via an unspecified route of administration in the left arm on 02Feb2021 at 09:30 (at the age of 49-years-old) as a single dose for COVID-19 immunization. Medical history included kidney cancer from 2009 and unknown if ongoing; costochondritis from an unknown date and unknown if ongoing; non-alcoholic fatty liver disease (NAFLD) from an unknown date and unknown if ongoing; gastroesophageal reflux disease (GERD) from an unknown date and unknown if ongoing; irritable bowel syndrome (GERD) from an unknown date and unknown if ongoing; migraines from an unknown date and unknown if ongoing, low immunoglobulin A (IgA) from an unknown date and unknown if ongoing; and steri strip allergy from an unknown date and unknown if ongoing. Prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medications included rosuvastatin calcium (CRESTOR) from an unknown date for an unknown indication; vitamin D from an unknown date for an unknown indication; and vitamin B12 from an unknown date for an unknown indication. The patient previously received a dose of BNT162B2 (lot number EK5730) in the left arm on 12Jan2021 for COVID-19 immunization. On an unspecified date in 2021 (reported as 02Jan2021 at 15:00) the patient experienced bitter metallic taste in his mouth, fatigue, arm soreness, lip tingling and headache. The events were reported as non-serious and did not require hospitalization. No treatment was provided for the events. Lab tests and procedures included polymerase chain reaction via nasal swab on 31Jan2021 with negative results. The clinical outcomes of bitter metallic taste in his mouth, fatigue, arm soreness, lip tingling and headache were not recovered. It was also reported that since vaccination the patient was tested for COVID-19.
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| 49 | 2021-03-04 | tingling |
Left arm tingling after vaccination that did not go away after 30min. Evaluated by EMS. ST elevation...
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Left arm tingling after vaccination that did not go away after 30min. Evaluated by EMS. ST elevation in screening lead 2, 12 lead performed but revealed only enlarged QRS, no ST change. No resp distress, no chest pain, given aspiring by EMS and transferred to hospital for continued monitoring and observation.
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| 49 | 2021-03-06 | tingling |
Developed prickly feeling and slight rash...perhaps some mild hives about 11 hours after the vaccine...
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Developed prickly feeling and slight rash...perhaps some mild hives about 11 hours after the vaccine. I also felt like I had a bit of a lump in my throat. I called the Doctor's office and spoke with a nurse who suggested I take Benadryl. I did so at around midnight and that seemed to take care of things. Went to bed and woke up the next morning feeling ok (though groggy from the Benadryl).
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| 49 | 2021-03-07 | depressed level of consciousness |
Patient was administered COVID vaccine while in ER for monitoring of possible reaction. Per ER repor...
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Patient was administered COVID vaccine while in ER for monitoring of possible reaction. Per ER report: "Pt noted to be having reaction, pt with decreasing level of consciousness (groggy), did answer questions. Epi/Benadryl given from bedside. VSS at that time. Currently speech is slow but does answer appropriately." Patient was discharged home.
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| 49 | 2021-03-07 | numbness, numbness and pain in extremities |
Peripheral, digital neuropathy: Dysaethesia in fingers Dig 4 and 3, first occurence in the left Hand...
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Peripheral, digital neuropathy: Dysaethesia in fingers Dig 4 and 3, first occurence in the left Hand. The dysaesthesia was self limting (at least to date and lasted ca 5 days), now I have it on the right hand on Dig 4. No motor function issues observed, purely dysaethetic in nature. Tactililty altered and reduced. Whole finger is affected, albeit distal lateral portion most. No other issues, left hand , Dig 4 is almost back to normal sensation (80%). No neurological history personal or in the family- ever. No treatment attempted, resp what would help anyway?
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| 49 | 2021-03-10 | bell's palsy | Bell's palsy(Left face) |
| 49 | 2021-03-12 | flushing, tingling |
Pfizer-BioNTech COVID-19 Vaccine EUA: 10 minutes after vaccination patient reported flushing, dizzin...
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Pfizer-BioNTech COVID-19 Vaccine EUA: 10 minutes after vaccination patient reported flushing, dizziness, lightheadedness, and tingling. Vital signs all within normal ranges. Transported to emergency department where physical exam was normal; neurological exam reported no focal deficits. Patient denied chills, blurred vision, shortness of breath, nausea, pain (including chest pain), rash, and headaches. Patient observed, symptoms resolved, and discharged to home stable.
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| 49 | 2021-03-14 | weakness, pain in extremity |
On the day of the shot I had a little soreness in my arm but on day 2 I couldn't lay down on that ar...
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On the day of the shot I had a little soreness in my arm but on day 2 I couldn't lay down on that arm because it hurt. For 4 days I had to have a nap during the day because I ran out of energy. However, since that shot I feel like I have been living in a "brain fog" because I can tell I'm processing things slower and it's not getting better.
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| 49 | 2021-03-15 | tingling |
Received first dose vaccine at approximately 1045 began feeling tingling in hands and lips about 20 ...
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Received first dose vaccine at approximately 1045 began feeling tingling in hands and lips about 20 minutes later. Vitals were taken and remained stable. Patient was given citirizine 10mg orally and symptoms began improving at approximately 1115. Symptoms resolved completely by 1200.
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| 49 | 2021-03-17 | unresponsive to stimuli, flushing |
Systemic: Fainting / Unresponsive-Medium, Systemic: loss of color, unresponsive, sweating. epipen gi...
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Systemic: Fainting / Unresponsive-Medium, Systemic: loss of color, unresponsive, sweating. epipen given. ems evaluated and determined stress rxn and sent home. -Medium, Systemic: Flushed / Sweating-Medium
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| 49 | 2021-03-18 | pain in extremity |
bleeding; my skin on my hands and the bottom of my feet started to peel off; very painful in the fin...
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bleeding; my skin on my hands and the bottom of my feet started to peel off; very painful in the fingers and the feet; This is a spontaneous report from a contactable other healthcare professional (patient). A 49-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL3249, expiration date not reported) via unspecified route of administration in the arm right on 21Jan2021 at single dose for COVID-19 immunisation. Patient medical history and concomitant medications were not reported. The patient previously took iodine and experienced drug allergy; also received first dose of bnt162b2 (Lot number: EJ1685) via unspecified route of administration in right arm on 30Dec2020 14:00 for COVID-19 immunization. Facility type vaccine: clinic. It was reported that on 23Jan2021, couple of days after the second shot, patient experienced skin on hands and the bottom of my feet started to peel off and bleeding and very painful in the fingers and the feet. The events resulted in both: Doctor or other healthcare professional office/clinic visit, and Emergency room/department or urgent care. It was unknown if treatment received for the events. Outcome of all events was recovering.; Sender's Comments: Based on plausible temporal relationship and known drug profile, a contributory role of the suspect BNT162B2 cannot be excluded in the development of bleeding, skin exfoliation and pain in extremity. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 49 | 2021-03-22 | numbness |
Felt swelling in arm, third fourth and fifth finger on right arm became numb, tiny pinpoint red bump...
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Felt swelling in arm, third fourth and fifth finger on right arm became numb, tiny pinpoint red bumps appeared on arms and legs. Right eyebrow and extending down to the right cheekbone feels "puffy"
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| 49 | 2021-03-22 | numbness and pain in extremities, tingling | Peripheral neuropathy and/or paresthesia in hands, feet and (occasionally) face. |
| 49 | 2021-03-23 | tremor, feeling cold |
joint and muscle ache and fatigue, fever, chills, sweating, headache, shaking, cycling between feeli...
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joint and muscle ache and fatigue, fever, chills, sweating, headache, shaking, cycling between feeling cold and shaking to hot and sweating. I was positive for COVID-19 in April of 2020, the reaction to the first shot of the vaccine was worse than the virus itself (with the exception of chest congestion and cough). it is nearly 48 hours from receiving the vaccine and I feel slight improvement, but still have body and muscle aches, slight fever, chills.
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| 49 | 2021-03-24 | inability to speak |
Approximately 5 minutes after vaccination was administered, patient was diaphoretic, pale in color, ...
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Approximately 5 minutes after vaccination was administered, patient was diaphoretic, pale in color, and unable to speak. Blood pressure was taken (48/28) with a pulse of 24. Patient stated that he had not eaten anything that day prior to coming to get his vaccination.
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| 49 | 2021-03-25 | pain in extremity, night sweats |
Had a very strong erection through night most of the morning; Very horrible side effects; very unusu...
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Had a very strong erection through night most of the morning; Very horrible side effects; very unusual side effects, Was pretty crippling; Lost my voice; Left groin is terribly painful; I go urinate and it would come back; was very really weird; Groin is so tender; Leg is uncomfortable; couldn't walk/Balance was off; I was on the floor; couldn't even make me anything to eat; Lethargic; I pee pretty frequently; Head, the base of head is very uncomfortable; Had sweats last night really strong; Couldn't sleep; Left buttock and all the way down to my toes was extremely painful; Body aches and chills; Glands swollen; Headache; Sick most of the day; This is a spontaneous report from a contactable consumer. A 49-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 19Feb2021 15:00 (Batch/Lot number was not reported) at singe dose for covid-19 immunisation. Medical history included genital herpes, TBI (Traumatic brain injury), chronic laryngitis, low blood pressure, seasonal allergy, appendix taken out, sinus surgeries, no sense of smell, tonsils removed, allergy. It was reported that he got her vaccine (unspecified Vaccine) Friday afternoon at 3 o'clock pm mountain standard time. He was fine on Friday and Saturday, he was horrible, very horrible side effects, that's why he thought he need to call, very unusual side effects he had typical, he was really struggling to talk today. On on 19Feb2021 23:00 he lost my voice, my glands were swollen, body aches he experienced. He got my shot in my left arm, my left buttock and all the way down, all the way to my toes was extremely painful and it cuts through my groin area. My left groin which is terribly painful. patient left buttock, all the way down to the toes extremely painful and that continued into my groin. And he had erection, he had a very strong erection through night, most of the morning. He go urinate and it would come back that was very really weird. That was when he knew it was really weird. And he knew that Pfizer was the one that makes Viagra. And my groin is so tender. When he pee, he pee pretty frequently. He think that was the most unusual side effects. His head, the base of my head was very uncomfortable. He had sweats last night really strong. Today, he woke up, he could not sleep, he went to the bed early. He had no energy today, he was doing a lot (not clarified over the call). He do have a headache today and obviously my voice hasn't come back completely and my leg is uncomfortable, he couldn't walk he was like if he was drunk yesterday, he couldn't, my balance was off. He was on the floor. He couldn't even make me anything to eat. It was pretty crippling that it made me feel like. He was very lethargic and he was sick most of the day. he was just hoping to give you information. He waited for long time on the phone to share experience. I hope this information helps you, I mean the other people if having the same problems or maybe not. Consumer also stated, he cannot locate the card that was given to me. He could not locate today. He was doing my laundry today maybe it is in my pocket. he dig into my pocket, he guess could not find it. They gave me card but he was not sure if he had it. Date when started experiencing the events: Consumer stated, I would say the date of the vaccine 19Feb2021. It probably towards the evening, I would say late at about 11 o'clock. Still experiencing Consumer stated, I am experiencing mild headache. I am experiencing dull pain at the base of my neck. I am experiencing the tenderness in my left groin. I am experiencing a little pain when I pee. I am experiencing a little bit of body aches, chills. I haven't fully gotten my voice back. I feel so sick. The erection has subsided but my penis is painful, it is uncomfortable. For treatment Consumer stated he did today he took this afternoon about maybe 3 pm, he took 4 Ibuprofen. Outcome of the event had a very strong erection through night most of the morning was recovering, outcome of the events lost my voice, left groin is terribly painful, groin is so tender, left buttock and all the way down to my toes was extremely painful, body aches and chills, headache not recovered. Outcome of the other events unknown. Information about lot/batch number has been requested.
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| 49 | 2021-03-26 | weakness | Extremely ill,weak and somewhat flu like but tested negative for both |
| 49 | 2021-03-26 | pain in extremity |
Joints pain - hands, elbow, knee, wrist, ankle pain in the back - pain on my clavicle Pains are no...
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Joints pain - hands, elbow, knee, wrist, ankle pain in the back - pain on my clavicle Pains are not constantly, come and go every two or three days.
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| 49 | 2021-03-28 | tremor |
3/25: Approx 5 mins after injection, started breathing quickly and became lightheaded. Moments later...
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3/25: Approx 5 mins after injection, started breathing quickly and became lightheaded. Moments later, heart rate elevated north of 190 bpm and blood pressure went up to approx 180/100. Developed dry mouth (was very thirsty) and shaking/chills. Took about 60 minutes to stabilize. Went to ER for evaluation and tests around 2:30P. Received a liter of fluid. Both EKG and Bloodwork was indicated as normal. Released from hospital around 6P. Slept through most of the night. 3/26: heart rate was erratic all day. Would race and then stabilize throughout the day/night. Extremely lethargic. No trouble breathing (was able to breathe and take deep breathes) but took effort to breathe. 3/27: 1:40A woke up heart began racing at close to 200 bpm. Dry mouth, shakes. Similar to what I experienced immediately following the vaccine shot. Went to ER out of precaution. Symptoms stabilized after about an hour. Hospital did EKG, blood work and chest X-ray. all were normal, lungs were clear. However, glucose and bilirubin were both slightly elevated. 3/29: Still feeling lethargic. Heart rate has stabilized some but is still erratic. It easily increases from simply walking around the house (much more than usual). 3/30: Scheduled appointment with primary care physician 3/31: Scheduled appointment with cardialogist
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| 49 | 2021-03-29 | flushing | Fever, stiff neck, pain in low back, full body aches, flushed face. |
| 49 | 2021-03-30 | cold extremities, numbness |
pt. c/o of pain in the chest. heavy chest like someone is standing on my chest- pt. said. lt. hand...
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pt. c/o of pain in the chest. heavy chest like someone is standing on my chest- pt. said. lt. hand cold and numbness dizziness, blur vision. His leg numbness.
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| 49 | 2021-03-31 | slurring, tingling, numbness |
Patient received 2nd dose of vaccine at 1120 today . He had 2 petite mall seizures, tingling, numbne...
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Patient received 2nd dose of vaccine at 1120 today . He had 2 petite mall seizures, tingling, numbness to right hand, glazed stare, slurred voice within 30 min of receipt of vaccine. Patient transported to emergency room via wheelchair.
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| 49 | 2021-03-31 | numbness, burning sensation |
1 hour after receiving the vaccine, my face and neck on the side of the shot started to burn like a...
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1 hour after receiving the vaccine, my face and neck on the side of the shot started to burn like a nerve issue and then went numb. My arm where I received the shot went cold and burned. A friend came over and took the temperature of my hand because it was cold and it was 15 degrees colder than my other hand. I took 1 Benadryl of 25mg and laid down for a few hours. At around 4 hours after the vaccine my neck went stiff as well as my upper back. I am reporting this because I don't believe the neck and face going numb is a normal thing and it was concerning and had it continued I would have went to the ER. I am not sure if the Benadryl helped but maybe.
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| 49 | 2021-03-31 | tremor | uncontrollable shivering/shaking multiple times during the evening and night |
| 49 | 2021-04-01 | feeling cold |
1800 hrs at work(same day as shot 1), started feeling nausea, vomited several times from 1815-1830. ...
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1800 hrs at work(same day as shot 1), started feeling nausea, vomited several times from 1815-1830. started with chills and sweating then and extreme fatigue. 1845 started vomiting again until about 1900 when it ended with violent vomiting and retching. Left work early, freezing the whole way home. fell asleep on the couch in clothes, sweatshirt and two blankets due to chills. Slept for 2 1/2 hours, woke up feeling much better. next day had slight headache and slight lethargy.
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| 49 | 2021-04-01 | pain in extremity | Fatigue Chills Runny nose Sore arm |
| 49 | 2021-04-01 | pain in extremity | persistent left shoulder pain |
| 49 | 2021-04-01 | tremor | Loss of taste, smell Achy Fever and shakes Loss of appetite Irritability Lethargy |
| 49 | 2021-04-03 | coordination abnormal | Fever, loss of equalibrium (fall), loss of coordination. |
| 49 | 2021-04-03 | discomfort |
Shortness of breath when exercising or active. Slight fluid in lungs...lungs feel heavy. Must stop a...
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Shortness of breath when exercising or active. Slight fluid in lungs...lungs feel heavy. Must stop and catch breath, cough and rest. Has happened 7-10 times since vaccine. No fever. Some fatigue
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| 49 | 2021-04-03 | numbness, tingling |
Tingling and partial numbness on the left side of my face; from my left cheekbone down to just under...
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Tingling and partial numbness on the left side of my face; from my left cheekbone down to just under my chin.
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| 49 | 2021-04-03 | nerve pain |
adverse event: shingles; symptoms include itch, nerve pain, muscle pain, rash/sores; onset at 3 days...
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adverse event: shingles; symptoms include itch, nerve pain, muscle pain, rash/sores; onset at 3 days following covid vaccination treatment: Valacyclovir hcl 1 gram tablets (3 daily for 7 days); ibuprofen as needed; administered at 1 week following covid vaccination outcome: ongoing recovery
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| 49 | 2021-04-04 | tenderness |
Swelling and mild tenderness of lower left axilla; possible lymph node; developed the day after the ...
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Swelling and mild tenderness of lower left axilla; possible lymph node; developed the day after the vaccine which patient states was "injected roughly". Pt describes swelling into left chest; was seen in the ER on 4/3-4/3/21, and seen via video visit with me on 4/5/21.
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| 49 | 2021-04-05 | numbness, tingling | patient started day after vaccine with rt hand numbness and tingling and left hand trigger finger. |
| 49 | 2021-04-06 | facial paralysis, numbness |
Numbness on side of face and cheek/numbness went from his cheek up on to the temple area and jaw are...
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Numbness on side of face and cheek/numbness went from his cheek up on to the temple area and jaw area; Mouth pulls weird; Previous nerve damage in his neck that hadn't been acting up in about a year but it was acting up now; Previous nerve damage in his neck that hadn't been acting up in about a year but it was acting up now; Felt loopy; Some weird palsy going on in his face/mild palsy in the left side of the face/Felt like face was heavy on left side or drooping/left side of his face was sagging; This is a spontaneous report from a contactable consumer reporting for himself. A 49-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6203), via an unspecified route of administration on 23Mar2021 14:40 at single dose for COVID-19 immunization. Medical history included he had some previous nerve damage in his neck that had not been acting up in about a year. Concomitant medications were not reported. Historical Vaccine included first dose of BNT162B2 (Lot Number: EL9269) on 02Mar2021 for COVID-19 immunization. On 24Mar2021, patient had some facial numbness and mild palsy in the left side of the face. He stated he had some previous nerve damage in his neck that had not been acting up in about a year, but it was acting up then. He stated it was the feeling like when you go to sleep on something, and it felt heavier. He asked what he should do, if he should seek medical attention and for information on this. After providing information from the Prescribing information, he asked if the Bell's Palsy went away in these individuals in the clinical trials? He stated his wife just said that the left side of his face was sagging. He stated he did not think it was a stroke though because he could move that side of his face and can articulate everything. He felt loopy but did not feel like it was a stroke. Patient reported that basically he felt numbness on the side of his face and cheek. There were reactions when he smiled, it seemed a little bit off. There was a weird feeling and numbness in his face. The numbness went from his cheek up on to the temple area and jaw area, the numbness was primarily on the left side of his face. Patient had nerve damage in his neck already. Patient wanted to know if he should go somewhere with it, was it ok, what was going on with the numbness in his face. Patient thought the numbness in his face and cheek had worsened. Felt like face was heavy on that side or drooping: Caller reported that looking in mirror, the left side of his face did not react the same. Patient's face felt like it was heavy or drooping on the left side, but that it pulls up higher. Patient reported that his face looked ok. Mouth pulls weird: Patient reported that this could be from his prior nerve damage, it was like he had got some weird palsy going on in his face. Patient stated that he just wanted someone to tell him dude wait it out, go to the emergency room, go to the doctor. Patient inquired if the facial numbness was because he had prior nerve condition and if the Covid-19 vaccine had exacerbated his existing nerve condition. The outcome of the events were unknown.
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| 49 | 2021-04-06 | feeling hot |
Minutes after vaccination patient began feeling hot, was diaphoretic, hypotensive, and was placed in...
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Minutes after vaccination patient began feeling hot, was diaphoretic, hypotensive, and was placed in trendelburg position
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| 49 | 2021-04-06 | flushing |
Flushing/sweating, dizziness, chills. Initial BP 151/80 (pulse 80). Glucose 285. F/u BP 112/74 (puls...
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Flushing/sweating, dizziness, chills. Initial BP 151/80 (pulse 80). Glucose 285. F/u BP 112/74 (pulse 72). O2 sats 93% and 95%.
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| 49 | 2021-04-06 | pain in extremity | Very sore arm. Unable to move |
| 49 | 2021-04-07 | seizure |
He got the vaccine, 15 minutes later he got very fatigued, could not walk in his house and could bar...
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He got the vaccine, 15 minutes later he got very fatigued, could not walk in his house and could barely make it to the bed and had to lie down. He had headache, nausea, disoriented. Then he went to bed, woke up at 9:00 AM and had a seizure, which he has had in the past but it had been over a year. He rested after the seizure and knew what to do and it took 2-3 days to recover from that due to the weakness in the legs, disoriented. He has gotten stronger and is pretty much back to his normal self. He has not had any additional seizures since then. He had his FU physical today and she is aware of the seizure and told them to report the incident.
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| 49 | 2021-04-08 | burning sensation |
Rash all over my body that looks like chicken pox, which started in my hair. I have a bad patch betw...
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Rash all over my body that looks like chicken pox, which started in my hair. I have a bad patch between my breasts. It itches horribly. Severely tired. My body, especially my ears and face, have this feeling of being on fire occasionally. Stomach upset with diarrhea that hits suddenly. Horrible headache. Skin is extremely itchy and dry. I cannot think. Memory loss.
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| 49 | 2021-04-08 | unresponsive to stimuli |
I went with my wife, whom we were more concerned about possible reactions to the vaccine given her h...
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I went with my wife, whom we were more concerned about possible reactions to the vaccine given her history of anaphylaxis reactions to bee and wasp stings, has had to carry a Epi-pen always, so we stayed an additional 15 minutes for 30 minutes total before we left. She was completely fine throughout, I however as we were walking out I began to feel a little ?Off?, not necessarily nauseous or dizzy, just a bit Off. Told my wife that and that I wasn?t sure I should drive us home (I drove us there), so she drove. About 15-20 minutes into the drive, it got worse and I passed out. My wife says my eyes rolled in the back of my head with my eyes open but no responsive. She says she kept hitting my chest but I didn?t respond. I came to about 2 minutes after passing out. She asked me if I felt like I needed to goto the hospital, I told her I needed to eat, that I felt like what I needed was food, then we go from there. I did eat breakfast, an English muffin at about 8am that morning, it was almost 12:30 by that point. When I finally got food in me I felt much better and have had no adverse reactions since.
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| 49 | 2021-04-09 | flushing |
3/30/21 at 1:30 am until 4/1/21 approximately noon: 103 F fever, chills, joint aches, extreme fatigu...
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3/30/21 at 1:30 am until 4/1/21 approximately noon: 103 F fever, chills, joint aches, extreme fatigue, loss of appetite, difficulty sleeping, headache, brain fog. 4/1/21 until present: tachycardia / racing heart rate as high as 125 bpm, feeling flushed as though I have sunburn but without any sun exposure, forgetfulness / trouble focusing / brain fog , Insomnia and frequent awakenings from sleep, feeling dehydrated and head achy or thirsty frequently, more frequent than normal urination, urine clear or pale yellow.
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| 49 | 2021-04-10 | feeling of body temperature change | Had extreme soarness throughout entire body. Bad headache Chills Hot and cold episodes |
| 49 | 2021-04-10 | numbness |
I noticed numbness and blood withdrawal from my left toes when exposed to cold weather a few days af...
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I noticed numbness and blood withdrawal from my left toes when exposed to cold weather a few days after receiving the first shot. It started with my big left toe and has now spread to four other toes on my Left foot. Right foot is perfectly normal. I've never had raynauds like symptoms after living in alaska for almost 20 years.
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| 49 | 2021-04-11 | weakness |
Chills and body ache for 18 hours since symptoms started. Low energy and fatigue since the day aft...
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Chills and body ache for 18 hours since symptoms started. Low energy and fatigue since the day after the second dose of vaccine. Dizziness, stomach ache 10 days after the vaccine. A mont later after the vaccine (3/30) I had headache, body ache and chills for 6 days. COVID test was negative Palpitations started on 4/4. Dizziness, chills, dry eyes, weakness and fatigue until today.
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| 49 | 2021-04-11 | cold sweat |
Both the following are being experienced 1) Vertigo (sensation of movement, whirling or feeling off...
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Both the following are being experienced 1) Vertigo (sensation of movement, whirling or feeling off-balance) 2) Disequilibrium (feeling of unsteadiness or impending fall). They are worse in the early morning and brought on my rapid head movement while in bed. Symptoms remain throughout the day and are triggered by rapid movement (standing quickly). Severe enough that upon onset I am unable to stand and must come to the ground to seek stability. Also experiencing mild cold sweats during these attacks. Minor injection site pain was experienced but subsided after 48 hours.
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| 49 | 2021-04-11 | pain in extremity |
Sore arm, lasted 2 days. Swollen lymph node in collar bone area on right side. Still ongoing. Bac...
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Sore arm, lasted 2 days. Swollen lymph node in collar bone area on right side. Still ongoing. Back and joint pain lasted 36 hours. Mild chills lasted 48 hours.
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| 49 | 2021-04-11 | unresponsive to stimuli |
I counselled the patient prior to giving him the Pfizer Covid19 vaccine. He received the vaccine at...
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I counselled the patient prior to giving him the Pfizer Covid19 vaccine. He received the vaccine at 10:10am. During the 15 minute observation period, one of my technicians was standing next to him talking to another patient. She saw some papers slip out of patient's hand and noticed he was unresponsive when she tried to talk to him. She yelled out for help and I ran out and saw his head rolled back, eyes open, and he sounded like he was snoring. He never left the chair--just his head rolled back. We tried to rouse him awake and I had my other technician call 911. I also called for a store manager. The patient came to about 15-30 seconds later. I asked him his name, what day it was, and if he knew where he was. He answered all questions correctly. He told me that he's fainted before after vaccines, however he never disclosed this to me prior to the vaccine and had answered "no" under the question if you've ever had a serious reaction to the vaccine. We gave him some water and a cold paper towel. The paramedics came and evaluated him. He declined to go to the hospital and his wife came and picked him up.
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| 49 | 2021-04-12 | one side paralysis |
Had subarachnoid hemorrhage 1 hour after getting shot. Ended up in hospital for 13 days. Had drain ...
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Had subarachnoid hemorrhage 1 hour after getting shot. Ended up in hospital for 13 days. Had drain placed in head and multiple CT scans and MRI exams while there. Discharged with home PT and neurologist follow ups. Experiencing left side weakness and head fogginess still.
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| 49 | 2021-04-14 | weakness | Severe lower back pain at site of herniated disk, fever, diarrhea, weakness. |
| 49 | 2021-04-14 | feeling hot |
Started experiencing some dizziness on March 8th that lasted for approximately 3 weeks. Did get the ...
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Started experiencing some dizziness on March 8th that lasted for approximately 3 weeks. Did get the second dose of the Pfizer vaccine and a week later felt a sort of hot feeling in my head similar to that ballon sensation when first coming down with the flu but nowhere near as intense. The dizziness was worst on March 10th then slowly resolved itself over the next few weeks. It was mild to moderate in intensity, I could feel a continuation of movement after turning my head sideways, it felt like the head was still going. Strange. I was still able to go to work but the effect was noticable. The only variables in my life recently were beginning Humira on Feb 2nd 2021 and getting the series of Pfizer Covid vaccines on Feb 19 and March 12. I did notify my gasteroenterologist because at first I assumed it was the Humira. He said that is not a side effect. On further research I have seen a lot of people reporting vertigo several weeks out after the Covid shots as if the antibody formation produces and inflammatory response in the ear in some patients. Unknown the symptoms are related to the shot or not. I had one outbreak of Meniere's Disease in 2006 and has not recurred. Perhaps the vaccine can cause a recurrance?
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| 49 | 2021-04-14 | muscle spasms, unresponsive to stimuli |
Patient was in observation for 15 minutes, before releasing patient nurse noticed that patient looke...
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Patient was in observation for 15 minutes, before releasing patient nurse noticed that patient looked as if they were going to pass out. Nurse pulled patient aside and shortly after patient's eyes began to roll back and started to have muscle spasms an became unresponsive. Nurse layed patient back and gave sternal rub in attempt to awaken the patient. Patient remained unresponsive and nurse administered epi pen 0.3mg to left thigh. Patient awoken after 3 minutes and became alert. EMS arrived and transported patient to emergency room.
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| 49 | 2021-04-15 | numbness |
Jaw locking up, numbness across face from mouth back to ears, severe pain in posterior neck radiatio...
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Jaw locking up, numbness across face from mouth back to ears, severe pain in posterior neck radiation to jaw, feels like jaw is in a vise.
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| 49 | 2021-04-15 | muscle spasms |
stomach ache and diarrhea about 7-9 hours after shot that lasted about 24 hours leg cramps about 18 ...
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stomach ache and diarrhea about 7-9 hours after shot that lasted about 24 hours leg cramps about 18 hours after shot while sleeping (only an issue the first night) general malaise for 72 hours after shot massive headache that started 48 hours after shot and lasted ~24 hours before turning into a milder but continuous headache for about 4 days. Around the time the headache turned milder I developed a case of tinnitus which has still not gone away. Tinnitus is ever present in both ears
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| 49 | 2021-04-17 | tingling |
Metallic taste hour about an hour after shot that lasted about an hour. Severe headache that lasted...
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Metallic taste hour about an hour after shot that lasted about an hour. Severe headache that lasted about 4 days, mild headache another 3 days Most concerning was a super sensitive, tingly lower back. A ?rash? developed Monday (4/12). I went urgent care on 4/17 and was diagnosed with shingles.
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| 49 | 2021-04-17 | tremor, night sweats | Shaking, chills, and night sweats. |
| 49 | 2021-04-18 | weakness, hot flush |
The evening of the shot my body basically turned on itself and began an all out mission to rid the v...
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The evening of the shot my body basically turned on itself and began an all out mission to rid the vaccine. Of course, that couldn't happen, but my body was going to proceed until I was dead or recovering. I began having severe chills, roasting heat flashes, headache, and body ache. Every sweat gland turned on full blast and did not turn off. I began to vomit in outrageous fashion. As violent as I've ever experienced. I had "sessions" of vomiting at least thirty times from Thurs night to Monday afternoon. When I could get out of the bathroom, I would collapse back into my sweat soaked bed. I would have an awful time trying to catch my breath. It would be up to ten minutes of hyperventilating and racing pulse, until it would suddenly normalize. And then I'd be utterly exhausted and slip into some kind of semi-sleep coma. This would not last even an hour before I'd be racing to the bathroom again. This was the first sixty hours. Vomit. Hyperventilate. Wish for death. Sleep coma. Repeat. About 24 hrs in I added severe diarrhea that was a part of every bathroom journey from then on. Ate nothing. Couldn't take normal meds. Sipped some pedialite. Late Sunday I turned a corner and felt like I wouldn't die. Took a full seven days for me to get any energy back and feel human again.- Every single symptom besides headache, was the worst I've ever experienced.
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| 49 | 2021-04-18 | bell's palsy | Bell's Palsy on Right side of face |
| 49 | 2021-04-20 | weakness |
Extended period of lethargy after second injection, from day 7 (post injection) to at least day 18. ...
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Extended period of lethargy after second injection, from day 7 (post injection) to at least day 18. Afternoon and evenings are mentally cloudy, low energy, and sleepy, requiring afternoon naps, and loss of work every day. Symptoms were worst at about day 10 to day 14, post second injection, and gradually reducing in severity through day 18 (though still existing at this time of reporting).
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| 49 | 2021-04-20 | pain in extremity |
Starting night of 2nd vaccine, started having low grade fever, fatigue, arm pain. Continued for an a...
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Starting night of 2nd vaccine, started having low grade fever, fatigue, arm pain. Continued for an additional day. Started experiencing lupus flare symptoms 3 weeks after 2nd vaccine - rash, hair loss (alopecia), joint pain/swelling, low grade fever, worsening kidney function (elevated proteinuria). Continued to have symptoms for 2 months - led to change in medications with rheumatologist.
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| 49 | 2021-04-22 | pain in extremity |
Severe pain in foot 1 day after injection. Pain increased about 4 hours after running. Doctor repo...
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Severe pain in foot 1 day after injection. Pain increased about 4 hours after running. Doctor reported bursitis in the left foot heel.
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| 49 | 2021-04-22 | unresponsive to stimuli, seizure |
Two 10 second convulsions followed by paleness and sweating. Patient was anxious prior to shot and w...
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Two 10 second convulsions followed by paleness and sweating. Patient was anxious prior to shot and was not responsive during convulsions. Wife stated that he "always has this reaction". Nurse Practioner that administered the vaccine stated that it was congruent with classic vasovagal symptoms after immunization. EMS arrived but patient did not want to go with them.
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| 49 | 2021-04-24 | numbness and pain in extremities |
Existing light neuropathy in feet and hands increased about 4-5 days after first dose. Feet more pro...
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Existing light neuropathy in feet and hands increased about 4-5 days after first dose. Feet more pronounced than hands. Seems to be progressing vs receding. Have not had second dose yet. The neuropathy is not extremely painful or debilitating but is probably 25-50% more pronounced in my feet post vaccine and doesn't seem to be subsiding may be getting worse, but hard to tell. Definitely some sort of reaction.
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| 49 | 2021-04-24 | pain in extremity |
continued arm pain after 12 days. goes from my shoulder down to my forearm.; The is a spontaneous r...
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continued arm pain after 12 days. goes from my shoulder down to my forearm.; The is a spontaneous report from contactable consumer. A consumer (patient) reported for self that the 49-year-old male patient received first dose of bnt162b2 (BNT162B2, COVID19, Pfizer), via an unspecified route of administration on 24Mar2021 16:00 at single dose for covid-19 immunisation. Medical history included covid-19 from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced "continued arm pain after 12 days. goes from my shoulder down to my forearm" on 25Mar2021 with outcome of not recovered. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No treatment was received for the adverse event. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No allergies to medications, food, or other products. Reporter wanted to discuss a possible side effect that he is experiencing after he received the firs dose of the vaccine. He did not elaborate further. No Follow-up attempts are needed. No further information is expected.
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| 49 | 2021-04-25 | tremor, hot flush |
The night of the second vaccine, I experienced severe chills, sweating and uncontrollable shivering/...
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The night of the second vaccine, I experienced severe chills, sweating and uncontrollable shivering/shaking. The next day I began experiencing headaches, body aches, nausea and continued hot flashes and waves of fever. This has now persisted for over 48 hours.
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| 49 | 2021-04-27 | tremor |
Flared- Autoimmune Disorder; Flared- Autoimmune Disorder; Extreme Fatigue; Fever; Headache; Body Ach...
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Flared- Autoimmune Disorder; Flared- Autoimmune Disorder; Extreme Fatigue; Fever; Headache; Body Aches; Muscle Tremors; Rash on Tongue and Lips; Rash on Tongue and Lips; This is a spontaneous report from a contactable consumer. This 49-year-old male consumer (patient) reported for himself that he received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported) via an unspecified route of administration in right arm on 01Apr2021 12:00PM (at the age of 49-year-old) at single dose for COVID-19 immunisation. Relevant medical history included known allergies to mushrooms, latex and adhesive; mystenias Gravis (preliminary diagnosis) and autoimmune disorder (still in research). The patient had not COVID prior to vaccination. Concomitant medications were not reported. On 01Apr2021 12:00PM the patient experienced extreme fatigue, fever, headache, body aches, muscle tremors, rash on tongue and lips flared- autoimmune disorder (diagnosis still pending research - as reported) symptoms lasted for more than 4 days. The patient was tested for COVID post vaccination - no results reported. The events were resolving at the time of report. Information on the lot/batch number has been requested.
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| 49 | 2021-04-28 | discomfort |
Increased resting heart rate. Noticed that my heart started to pump harder, first during an afterno...
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Increased resting heart rate. Noticed that my heart started to pump harder, first during an afternoon while sitting, no stress or agitation. The next morning, I woke up in the middle of the night due to some discomfort. I was at 100 BPm (normally at 60).
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| 49 | 2021-04-28 | facial paralysis, slurring | 4/23/21- Experienced lip numbness 4/24/21- current - Eyes, cheek, mouth droopy and slurred speech. |
| 49 | 2021-04-28 | flushing, feeling hot | Flushing - feeling of warmth, anxiety. Received water. BP 144/61 (pulse 89), 160/78 (pulse 82). |
| 49 | 2021-04-28 | night sweats, tingling | Chills, night sweats, fever, arm tingling, muscle aches |
| 49 | 2021-04-28 | pain in extremity |
Arm/Shoulder are extremely sore. Mainly at night or when arm is at rest for period of time. Been...
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Arm/Shoulder are extremely sore. Mainly at night or when arm is at rest for period of time. Been going on for a week and its not getting better.
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| 49 | 2021-04-28 | tingling, pain in extremity | Muscle aches, intense arm pain, left arm tingle |
| 49 | 2021-04-28 | tingling |
Hypertension spike since 1st dose of vaccine (averaging 150/100) since getting vaccine. Lightheaded...
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Hypertension spike since 1st dose of vaccine (averaging 150/100) since getting vaccine. Lightheaded, shortness of breath. No history of Hypertension (though always on the borderline (averaging 120/80).
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| 49 | 2021-04-29 | bell's palsy |
3 days of intractable headache beginning 4/11. Right sided facial symptoms beginning 4/14 - diagnosi...
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3 days of intractable headache beginning 4/11. Right sided facial symptoms beginning 4/14 - diagnosis of Bell?s palsy. Later diagnosis of cluster headaches. Treatment: prescribed 7 days of Prednisone (60mg) and Valtrex. Currently acupuncture 2x weekly, oral B12 (2500mcg), TCM herbal supplements. Prescribed Sumatriptan for h/a but not used as they have subsided. Headaches currently subsided to jaw only. 15 days after diagnosis, Bell?s palsy symptoms show very minor improvement (R eyelid more functional now).
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| 49 | 2021-04-29 | cold sweat, unresponsive to stimuli |
Client received COVID vaccine @ 3:45pm. Client in observation area, reported having "cold sweats" t...
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Client received COVID vaccine @ 3:45pm. Client in observation area, reported having "cold sweats" to EMT staff @ 3:55pm. EMT staff provided client with water, attempted to assist client to zero-gravity chair. Client became unresponsive @3:58pm. Client became responsive @4:01pm, transferred over to cot with assistance, with legs raised. Client able to speak, denies shortness of breath, reports "anxiety with injections and anything going in to my body". Vital signs @ 4:06pm, BP 102/58, P 87, RR 12, O2 sat 97%. Client continued with observation, provided with water. Vital signs @ 4:14, BP 104/60, Pulse 82, RR 12. Client reports he feels much beter, able to sit up in chair. Client advised to follow up with primary care, client reports he will call parents for ride home. Client left observation area @ 4:30pm, walking with steady gait.
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| 49 | 2021-04-29 | feeling hot |
1st shot: No adverse reactions after the shot. 2nd shot: 3 minutes after the second shot, felt warm ...
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1st shot: No adverse reactions after the shot. 2nd shot: 3 minutes after the second shot, felt warm wave in my body and became dizzy. Did not have additional side effects and left in 20 minutes. During driving back and 1 hr after the vaccination became even more dizzier and fatigued, with walking balance issues. Second day dizziness disappeared, but I had a pain in the area of the shot, headache, body aches, and fatigue, balance issues. 3rd day started recovering. 3-8 day side effects gradually disappeared but started having panic attacks and generalized anxiety which I suffered years ago.
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| 49 | 2021-04-29 | tingling, numbness |
Experienced tingling, numbness and weakness in my left arm shortly after receiving injection. The nu...
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Experienced tingling, numbness and weakness in my left arm shortly after receiving injection. The numbness was throughout my entire arm but was especially pronounced along the outside down to the pinky finger. Within about 2hours the numbness also affected my left leg along the outside of the leg to the pinky toe and all around the lower thigh. Symptoms still present 8 hours after injection at time of writing this description.
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| 49 | 2021-05-05 | muscle spasms |
4:40pm: Patient complained of arms cramping, back of head pounding, coughing blood, tachycardia; 1...
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4:40pm: Patient complained of arms cramping, back of head pounding, coughing blood, tachycardia; 16:48pm EMS called. 17:08 EMS Arrived; Vitals: 16:50pm 148/90 101 18 O2 100%; 1700pm 144/100 100 20 O2 100%; 1730pm EMS departed to hospital. Pt. status when transported to hospital: Stable, no longer vomiting.
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| 49 | 2021-05-09 | unresponsive to stimuli |
He felt very bad the night he received the 2nd shot of Pfizer covid-19 vaccine on April 27. He even ...
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He felt very bad the night he received the 2nd shot of Pfizer covid-19 vaccine on April 27. He even joked he probably would die that night. He also complained that despite his protest, the person who administered the shot insisted to inject on his shoulder joint. He developed a bigger-than-quarter-size bruise on his right inner arm the next day. He was feeling tired the following days. On May 4 around 3:30, I heard he was making loud noises. I came to his side immediately. At the time I thought he was making louder than usual snores. I nudged him gently but he didn't respond. After about 15 seconds, the sound stopped, and he had no breath. I then called 911 within 10 seconds, tried to do CPR on him. It took EMS 6 minutes to arrive even though we live very close to a fire station in a well-accessed urban area. EMS worked on him for about 30 minutes before transported him to hospital. They continued to work on him for a while. He never regained breath.
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| 49 | 2021-05-11 | numbness and pain in extremities, pain in extremity, sensory loss |
have some clots; Neuropathy; autoimmune disorder; Fell and hit elbow and 3 ribs on left side; lost 6...
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have some clots; Neuropathy; autoimmune disorder; Fell and hit elbow and 3 ribs on left side; lost 6 (lbs) pounds/Within 2 months, he has lost 47 lbs and eats all the time and is still losing weight; falling; felt super strong; dizziness; failed all the tests for motor skills for his arms and legs; Fell and hit elbow and 3 ribs on left side; Fell and hit head; Sensory nerves are all gone; Fatigue; scabs; delusional; tore tendons in between ribs; They are tender(ribs); hurting all over; Cannot walk or lift anything; chest pain; his arm was sore a little; Left arm injection site pain; Disoriented; This is a spontaneous report from a contactable consumer (patient). A 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 intramuscular, administered in left arm on 03Feb2021 (batch/lot number and expiration date not reported) at the age of 49 years old, as 1ST DOSE, SINGLE for COVID-19 immunisation. Medical history included COVID-19 from Dec2020 to an unknown date, vascular disease, bilateral stents placement, cataracts since he was born. Concomitant medication included gabapentin taken for an unspecified indication from an unspecified start date and ongoing. On 04Feb2021, the patient experienced left arm injection site pain. The patient experienced dizziness, falling, and couldn't go to work on unspecified date. He was treated by his (MD) physician, was given a CT scan, echocardiogram, and found to have some clots. He stated he has a history of vascular disease and had bilateral stents placed a year ago. He was placed back on an aspirin/Plavix regimen and referred to a neurologist because he has no motor skills anymore. He stated he failed all the tests for motor skills for his arms and legs. He was advised not to take the second dose of the vaccine and was diagnosed with neuropathy and autoimmune disorder (caller does not specify which disorder). He reported being positive for Covid-19 in Dec2020. He wanted to know what else he can do for his symptoms and is offering to be tested by Pfizer for treatment. The symptoms come in really hard seven days later. He actually had to go to the (ER) emergency and they worked on him and a whole string of doctors. He went to the emergency room and something was going on and wanted him to go to a family practitioner. They sent him to vascular, neurological and now they want to send him to a research center. It was a whole week after receiving vaccine before he began having symptoms. With the neuropathy and autoimmune, he cannot work like he did. He can hardly walk. Unspecified autoimmune was diagnosed last week. He can't remember the name of it. They told him not to take second one because the first one did what it did to him. It hurt a little and it was quick. The next day (04Feb2021), he said his arm was sore a little. He is only taking 4 medications and they looked it up. He did not think they were relevant. He was disoriented and fell and hit his head a couple of times. They ran an MRI on his head trying to figure that part out. That was done last week. He doesn't know the date and said it may have been on Friday. Results were good. The date he was disoriented was Wednesday 03Feb2021, when he took the shot. He has been disoriented and has been that way ever since. They kept him for 15 minutes to make sure no one passed out. He has been disoriented since then. He could not think clearly, and he could not do his job. He tore tendons in between ribs. He first thought he actually broke his ribs, but did not. There were two different falls. He cannot feel feet or anything. His motor skills are OK but when they did neuropathy test, they put needles in and shocked him to make his motor fire. His reflexes were really bad. He fell and hit elbow to keep from falling on face and twisted going down hitting 3-4 ribs on left side. It has been over 3 weeks now for his ribs. They are tender but they are not like the initial blow. It feels like they are healing. He fell and hit head a week ago. He was unsure of the exact date. He did not go to the emergency room with this one because the bed caught him. He fell and hit his head. All he has left is scabs. He cannot walk or lift anything (11Feb2021). That next Wednesday, he got ready to go to work and was so delusional and could not go in. He slept from 5:30 all that day and all that night. Then Thursday, he gets up and goes to work and goes slower, just to see what happened on Wednesday. He had fatigue and was disoriented. He did not provide start date or outcome for fatigue. He walked in and said either call an ambulance or he would go home. He went home and that was the last day of work. He then stated he laid in the car for 30 minutes and he said he is going to the emergency room. He went straight there that day. He had stents put in lower part of his body a year before. The neuropathy and the autoimmune kicked in 7 days later after the shot. The reason he went to the ER is because he thought it was his stent. He had bilateral, 4 of them. He was having chest pain and hurting all over on 11Feb2021. He thought he was having a heart attack. He was seen in the emergency room and released. It depends on how far he goes, how the chest pain worsens. Right now, he is ok, but when he gets up and moves around, it does the same thing. Within 2 months, he has lost 47 lbs and eats all the time and is still losing weight. He was about 200 something and was kind of built and now is skin and bones. He lost 6 (lbs) pounds within a week and is eating like crazy. Sensory nerves are all gone. If hit with a baseball bat and he would not feel it. It came on slowly almost that he did not know it was happening. That is why they want to send him to Privacy for a research center and he does not want to go. He never had this happen before. ER or physician's office required: 1st date was on Thursday, 11Feb2021, when he went to Privacy. He was having chest pain and hurting all over. He thought he was having a heart attack. He was released. The patient stated he wanted to change the information he had provided since he was not in his right mind since he had taken the wrong medication dose than the doctor had given him. He stated the medication dosage he wanted to change was for Amiripyin. He stated he wanted to say he told the representative the symptoms he had experienced was enhanced which they were yesterday because he was trying to fight everything and stay awake. COVID 19 vaccine: he stated the doctor did not want him to take the second dose of the vaccine. He stated one of the symptoms he had experienced after the vaccine that he wanted to change the outcome for is the neuropathy. He stated he is back to where he used to be and yesterday it was bad he could hardly walk or talk. He stated also the other symptoms he wanted to change the outcome for is the autoimmune. The patient has not recovered from neuropathy, autoimmune disorder, disoriented, can't walk or lift anything, chest pain, and sensory nerves all gone; while outcome of the remaining events was unknown. Information on the lot/batch number has been requested.
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| 49 | 2021-05-14 | bell's palsy, numbness |
Bells Palsy; Facial numbness and drooping left side. Eye, cheek, lips.; This is a spontaneous report...
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Bells Palsy; Facial numbness and drooping left side. Eye, cheek, lips.; This is a spontaneous report from a contactable nurse. A 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 11Jan2021 15:00 (Batch/Lot Number: EK4176) as 2nd dose, single for COVID-19 immunization. The patient had no medical history. The patient's concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 21Dec2020 15:30 in the left arm (lot number: EH9899). The patient did not receive any other vaccines within 4 weeks prior the COVID vaccine. The patient experienced Facial numbness and drooping left side. Eye, cheek, lips; had Bells Palsy on 30Apr2021 11:00 which resulted a visit in the emergency room or urgent care. Steroids and acyclovir were taken as treatment for the events. The patient was not diagnosed with COVID prior vaccination and has not been tested after vaccination. The outcome of the event was unknown. The event Bells Palsy was assessed as serious- medically significant.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug in the reported serious event cannot be completely ruled out given the known suspect drug profile and/or implied temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to the Authorities, Ethics Committees and Investigators, as appropriate.
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| 49 | 2021-05-17 | pain in extremity |
Patient had vaccine on the 12th. Leg pain three days later. Diagnosed with DVT six days later. No ri...
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Patient had vaccine on the 12th. Leg pain three days later. Diagnosed with DVT six days later. No risk factors for DVT. Unknown lot number for vaccine. Not done at my faciluty
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| 49 | 2021-05-18 | tingling, pain in extremity, cold sweat |
Zero arm pain until around 8PM. Then came on and intensified for next two hours. Became very tired. ...
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Zero arm pain until around 8PM. Then came on and intensified for next two hours. Became very tired. Went to bed at 10PM. Woke up at 12;30AM with a 101 degree fever and intense pain in lower back/upper buttocks. Fever/pain persisted and worsened throughout the night. Aches spread to other areas of my body but still centralized to back/buttocks. Headache introduced in the AM. Fever bounced all day between 102 and 104.2 degrees all day until about 8:30PM on Sunday. Tried ibuprofen to manage pain and temperature but had minimal effect. General tingly and buzzy feel after 8:30PM and into Monday. Headeache reappeared on Monday evening with cold sweats. Strange calf ache in right leg Monday night into Tuesday AM that consistently woke me up. Tried massage, stretching, to no avail. Tuesday AM most everything dissipated with just a bit of fogginess throughout Tuesday (though less than Monday).
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| 49 | 2021-05-19 | pain in extremity |
Arm pain; aches; tiredness; This is a spontaneous report from a non-contactable consumer (patient). ...
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Arm pain; aches; tiredness; This is a spontaneous report from a non-contactable consumer (patient). A 49-year old male patient received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 17Feb2021 12:30 (Lot Number: EL3247) as single dose (at age of 49-year-old) for covid-19 immunisation. Medical history included asthma. Patient received first dose of bnt162b2 (BNT162B2) on 26Jan2021 at 12:00 PM in Left arm (at age of 49-year-old) for covid-19 immunisation, lot number: EL3247. Concomitant medications in two weeks included ubidecarenone (COQ10), ergocalciferol (VIT D), glucosamine (GLUCOSAMINE). Patient did not receive any other vaccine in four weeks. On 18Feb2021 patient experienced arm pain, aches, tiredness. Patient was able to perform work but at a reduced pace. No treatment was received for the events. Patient did not have COVID prior vaccination and also patient was not tested for COVID post vaccination. Patient had not recovered from the events, at the time of the report. No follow-up attempts are possible. No further information is expected.
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| 49 | 2021-05-20 | night sweats |
Patient readmitted on 5/19 who was just discharged on 5/15. Patient initially presented with fever, ...
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Patient readmitted on 5/19 who was just discharged on 5/15. Patient initially presented with fever, SOB, lymphadenopathy, diffuse maculopapular rash. He had his first dose of COVID vaccine (Pfizer) on 4/23, and his symptoms began on 4/29. He was itchy all over, but when he developed fever and SOB he came to the ER on 5/2 and was discharged on prednisone. His symptoms continued and so he came back to the ER and was admitted. He had a lymph node biopsy to rule out lymphoma (pathology returned negative for lymphoma). He was treated empirically with ceftriaxone and doxycycline. He tested + for EBV IGG but not IGM. EBV PCR was pending upon discharge. He had a borderline positive lyme serology. He was discharged on doxycycline and steroids with improved symptoms. He returned to the ER with again worsening SOB, night sweats, worsening rash, recurrence of fever. He denies sore throat or any sick contacts. He reports a normal appetite. He was found to be hypotensive and in AKI.
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| 49 | 2021-05-23 | feeling hot |
Patient received dose 2 of the Pfizer COVID vaccine (lot EW0179, exp 8/2021) at 1300. At 1318, patie...
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Patient received dose 2 of the Pfizer COVID vaccine (lot EW0179, exp 8/2021) at 1300. At 1318, patient was sitting in the observation area when he informed EMT that he felt dizzy, warm, and had blurry vision. EMT informed PHN who came over to assess. At 1320, vital signs: blood pressure 130/86, O2 97%, pulse 93, respirations 18. Patient reported blurry vision had resolved. EMT r offered to have patient lay down in the zero-gravity recliner but patient declined. Patient denied allergies, medical conditions, or taking medication. Patient reported eating breakfast and that he experienced no adverse reaction to dose 1. PHN encouraged patient to follow up with provider and when to contact 911. PHN offered Benadryl but patient declined. At 1326, vital signs: blood pressure 124/82, pulse 97, O2 98%, respirations 18. Patient reported all symptoms had resolved. Patient stood up, reporting no dizziness or remaining symptoms. PHN encouraged patient to wait for 30min since onset of symptoms, patient stated he was leaving. Patient left AMA, walking with steady gait at 1330.
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| 49 | 2021-05-25 | weakness |
Dizziness and weakness, injection site pain, tiredness, headache, muscle pain, chills, fever, nausea...
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Dizziness and weakness, injection site pain, tiredness, headache, muscle pain, chills, fever, nausea, diarrhea
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| 49 | 2021-05-25 | bell's palsy | I developed Bell's Palsy |
| 49 | 2021-05-25 | tingling, muscle twitching |
had twitching and tingling sensations all over his body, mostly in his legs, thighs, calves, ankles,...
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had twitching and tingling sensations all over his body, mostly in his legs, thighs, calves, ankles, and occasionally in his lower and upper arm as well as his fingers; big finger twitch/had twitching and tingling sensations all over patient body, mostly in his legs, thighs, calves, ankles, and occasionally in his lower and upper arm as well as his fingers; This is a spontaneous report from a non-contactable consumer (patients wife) via medical information team. A 49-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date were not reported) via unspecified route of administration on 23Mar2021 (at the age of 49-year-old) as 2nd dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Reportedly, patient received historical vaccine first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date were not reported) via unspecified route of administration on 02Mar2021 as 1st dose, single for COVID-19 immunization. Reportedly, on an unspecified date in Mar2021 (48 hours after the second dose) patient experienced very big finger twitch. On an unknown date (Within last 2 or 3 days) patient had twitching and tingling sensations all over patient body, mostly in his legs, thighs, calves, ankles, and occasionally in his lower and upper arm as well as his fingers. Reporter wanted to know if it was related to the vaccine. Reporter stated that while they were researching about it, they saw that bells palsy has also been reported with the use of the vaccine. Reporter also said that there were some people who had the same reaction as patient after receiving the vaccine. Reporter mentioned that patient was from (place name withheld), and they said that they heard about an existence of a Bells Palsy-like symptoms there. With that, reporter wanted to know if there was any information about neurological side effects or something similar to Bells Palsy that may be associated with the vaccine. Reporter also wanted to know what they should tell the doctor once they meet up with him or if there was any additional information from Pfizer that she could tell their doctor to help rule out what patient had. The outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
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| 49 | 2021-05-27 | pain in extremity |
I have a broken shoulder and my humerus bone broke; I have a broken shoulder and my humerus bone bro...
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I have a broken shoulder and my humerus bone broke; I have a broken shoulder and my humerus bone broke; May be just felt a little bit of a sore arm; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 49-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiration date was not reported) via an unknown route of administration on 05May2021 as 2 nd dose, single for Covid-19 immunization. The patient received co suspect Ibuprofen (IBUPROFEN) 800 mg in the morning (Batch/Lot number: not reported), Paracetamol (TYLENOL) 1000 mg (around 12 took Tylenol 1000 mg) (Batch/Lot number was not reported) via an unknown route of administration on an unknown date for an unknown indication. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 on an unknown date as SINGLE for Covid-19 immunization and experienced no adverse event. On an unknown date, the patient experienced to have a broken shoulder and humerus bone broke and may be just felt a little bit of a sore arm. It was reported that patient had been hearing multiple news conferences about aspirin and ibuprofen when receive Pfizer vaccinations as it lowers the dose of vaccination. It was reported that patient was informed not to take Ibuprofen and Tylenol whatsoever and patient had been taking it all long like Ibuprofen 800 mg in the morning and then Tylenol 1000 mg around 12 and patient did not felt the first vaccine even the second vaccine patient did not feel nothing. May be just felt a little bit of a sore arm other than that nothing and patient do not feel protected. The outcome of the events was unknown. No follow-up attempts were possible; information about lot/batch number cannot be obtained.
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| 49 | 2021-05-28 | pain in extremity |
Upon waking up the morning following the injection, a ~2 inch diameter erythema was present on the p...
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Upon waking up the morning following the injection, a ~2 inch diameter erythema was present on the patient's upper arm at the injection site. In the center was a ~1 inch raised bump, painful and hot to the touch. Later in the day, corresponding to ~24 hours post injection, the patient developed 101 degree fever, an unusually strong headache, chills and myalgias. The symptoms peaked ~28 hours post injection. The patient took 1,000 mg of acetominophen which didn't appear to have an impact. Before going to bed that day, the patient took a full dose of Nyquil liquid. The fever, headache, myalgias and chills resolved overnight. The arm was painful and the myalgia/bump persisted for 4 additional days.
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| 49 | 2021-05-31 | sciatica |
4/21: Felt "explosion in head," lightheaded, poor focus, vision off, felt like concussion, fatigue, ...
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4/21: Felt "explosion in head," lightheaded, poor focus, vision off, felt like concussion, fatigue, "my computer short circuit", spinning, dizzy, anxiety, "eyes darting", racing thoughts at night while trying to sleep. 4/26: light sensitivity, new onset sciatica, hypersensitivity, inability to focus, spinning. 2nd phase: right posterior occipital pain (neuralgia). 3rd phase: moving eyes, felt crunching noise. Vertigo treated with vestibular therapy. Anxiety/insomnia treated with Xanax.
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| 49 | 2021-05-31 | sensory loss, numbness |
Patient reports to the pharmacy 3 days after receiving the 2nd dose of his Pfizer vaccine, complaini...
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Patient reports to the pharmacy 3 days after receiving the 2nd dose of his Pfizer vaccine, complaining of complete numbness and loss of sensation in both hands along with swelling of right hand. Vaccine was received on the afternoon of 5/29 and patient reports a loss of sensation in both hands beginning that evening. This has continued for 3 days up to today morning (06/01) where patient reports some improvement in degree of swelling of right hand and a return of some feeling in both hands.
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| 49 | 2021-06-01 | bell's palsy |
I developed Bell's Palsy, paralysis on my left side of my face. This occur 3 weeks after I receive m...
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I developed Bell's Palsy, paralysis on my left side of my face. This occur 3 weeks after I receive my first dose of the Pfizer vaccine. I could not close my left eye, inability of smile, drooling, facial distoration, difficulties in eating.
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| 49 | 2021-06-01 | burning sensation |
Pharmacy reported to patient that he was given a full vial of the vaccine instead of one dose. They ...
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Pharmacy reported to patient that he was given a full vial of the vaccine instead of one dose. They indicated the error was not diluting it before giving him what they thought was one dose. He reported that it burned when he was injected with the vaccine.
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| 49 | 2021-06-01 | hot flush, tingling |
Headache; hurt right below my chest and in stomach; skin became extremely prickly; Low grade fever l...
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Headache; hurt right below my chest and in stomach; skin became extremely prickly; Low grade fever like 99; Dimer test showed kind of high levels with mainly blood clot; some fiber or Fibrogen which was for thickening of blood/ supposed to be between 400 and 420, his was 879; have COVID, it was positive COVID antigen test; have COVID, it was positive COVID antigen test; felt pressure in his back almost like pneumonia; Chills; sweat; Hot flashes; Stomach was cramping/ hurt right below my chest and in stomach; This is a spontaneous report from a contactable consumer (patient). A 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route on right shoulder single dose for COVID-19 immunization; second dose with lot number: EV10161 on 22Apr2021, first dose with lot number: EP7533 on 01Apr2021, at 49-year-old. Medical history and concomitant medication were not reported. The patient was non-smoker, non-drinker. The patient had a little headache with the second shot but 2 weeks later on 03May2021 started having chills every night and would sweat. He was having chills and hot flashes and stomach was cramping and when inhaled like taking a deep breath, felt pressure in his back almost like pneumonia like lungs were filling with fluid or clotting. On the 07May2021, he took a little flu medication Theraflu over the counter (treatment) thinking that'd clear it up. Every time he took a deep breath, it'd just hurt right below my chest and in stomach and skin became extremely prickly. He'd have like a low-grade fever like 99. This was 2 weeks after the second shot, so he went to the ER on 07May2021 and was given a COVID test, a fluid test and lab work trying and figure what he was having. One of his blood test - Dimer test showed kind of high levels with mainly blood clot so they gave him a CT scan, scan showed no blood clots, no kidneys stones or anything like that should had any sweating. ER doctor gave him an antibiotic (ciprofloxacin) for infection like diverticulitis or diverticulosis. The doctor said the patient did not have a stomach infection, his tests showing such high levels for clots so the doctor did more lab work a PRC, CRT, TRP or CPR, a CRT lab work and some fiber or Fibrogen which was for thickening of blood. Those numbers are supposed to be between 400 and 420, his was 879 today (17May2021). The patient did have COVID, it was positive COVID antigen test, I got those results today (17May2021). Outcome of the events was unknown.
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| 49 | 2021-06-01 | migraine |
Client (received the COVID vaccine (Pfizer dose 2, lot # EW0187, expiration 6/28/2021) at 1800. At 1...
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Client (received the COVID vaccine (Pfizer dose 2, lot # EW0187, expiration 6/28/2021) at 1800. At 1829, the client reported itching on his skin and in his throat. EMT, EMT #2, PHN, and RN responded at this time. The client was sitting comfortably in his chair, alert and oriented x4. The client's vital signs were as follows: heart rate 57, O2 97, respiratory rate 14, blood pressure 150/92. The client's skin was pink, warm, and dry. The client denied any shortness of breath or chest discomfort. The client was able to speak in full sentences and had no visible swelling on his face or tongue. The client declined Benadryl at this time. The client stated he has environmental allergies and has had an anaphylactic reaction to trees in the past. The client stated he has a medical history of anxiety, acid reflux, migraines, and hay fever; he takes antacids, sumatriptan, and allegra. The client stated that he took 1 allegra at 1816, but stated he didn't know the exact dosage and did not have the medication bottle with him. The client was able to speak in full sentences. At 1835, the client identified a small, red, erethematous area approximately 1 centimeter in length on the left medial area of his elbow, which he stated itched. He also stated his eyes were itching; neither eye or eyelid appeared red. The client stated his throat was dry and was offered and accepted water. The client declined Benadryl again at this time. The client was transferred to the zero gravity chair at this time, denied any dizziness during ambulation or transfer. At 1839 the client's vital signs were as follows: blood pressure 142/84, heart rate 74, O2 97%. The client stated "I had an itchy throat this morning" and said that he had a migraine that morning but did not remember if he had taken any medication for the migraine. At 1849, the client's vital signs were as follows: blood pressure 122/84, heart rate 73, respiratory rate 16, O2 99%. At 1853, the client stated "I feel less itchy." At 1900, the client initially requested Benadryl, but then refused both the medication and vital signs when offered. The client stated that his arm "still itched" but denied that it was getting worse. The client stated "I wanted a Benadryl for the road but now I think I'm going to wait." The client denied shortness of breath, chest tightness or pain, or any difficulty breathing. The client did not appear to be in any distress and had no swelling visible on his face or tongue. The client continued to chat with staff and spoke with a pleasant demeanor. Education provided by PHN, EMT, and RN regarding primary care follow up and when to seek medical care. At 1915, the client requested Benadryl and stated "I think my rash is growing." The client's vital signs at that time were as follows: blood pressure 138/92, heart rate 88, O2 99%, respiratory rate 12. At 1922, the client was given 50mg Benadryl orally. At 1927, the client stated "my wife is here, it's time for me to go." RN reiterated the importance of staying for a 30 minute observation time, but the client continued to leave the building. EMT accompanied the client outside, where he ambulated with a steady gait. He walked to the outdoor observation area and then sat down, requesting to be evaluated by EMS. EMS was called by RN at 1933. The client was sitting comfortably and denied any shortness of breath or chest pain. EMS arrived on scene at 1936. At 1938, the client's vital signs were as follows: blood pressure 140/90, heart rate 60, and O2 100%. The client stated at that time that he "felt better" and declined transport to the hospital. The client signed AMA paperwork at 1945 and ambulated to his car with a steady gait, accompanied by his wife, who he stated was going to drive him to an urgent care.
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| 49 | 2021-06-01 | pain in extremity | Disseminated, non-traumatic bruising, Pain and swelling in the leg. |
| 49 | 2021-06-01 | unresponsive to stimuli |
Patient was given the second dose of Pfizer Covid 19 vaccine on 6/2/21 at 12:29pm and was asked to w...
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Patient was given the second dose of Pfizer Covid 19 vaccine on 6/2/21 at 12:29pm and was asked to wait for 15 minutes to watch how the patient reacts with the vaccine. He didn't have any side effect on his first dose. After 3 minutes of getting the vaccine, his wife notified me that she needs assistance. He was sweating profusely and was about to lose consciousness. His wife and I kept saying his name to check his response. He could not response or was about to faint. His pulse is slow, and his face is red. Since there was other customers waiting for shots in the clinic, I asked the technician to ask for pharmacy manager assistance. He came in the clinic, and checked patient's pulse and blood pressure. The blood pressure was high (170/89). We checked his blood pressure again, and it was lower after couple minutes. Patient started to have consciousness and understand what we are talking. He told us that he always had the same reaction after getting his blood drawn. We asked him to sit down and was monitored by us in the clinic. After 30 minutes, he said that he was feeling fine without any problems and decided to leave. He can breathe ok and didn't have any adverse reactions such as swelling of throat and lip or hives. His wife and he didn't eat anything before getting the vaccine. I checked his blood pressure again, and it was 130/80. Will follow up on him this evening and tomorrow.
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| 49 | 2021-06-02 | pain in extremity |
Anaphylactic reaction; skin was on fire; sweating; stomach cramps; throwing up; his arms and saw the...
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Anaphylactic reaction; skin was on fire; sweating; stomach cramps; throwing up; his arms and saw they were solid red; inflamed; hands swelled up; itchy; sore; sore where injected the Testosterone into left arm.; sore where injected the Testosterone into left arm.; This is a spontaneous report from a contactable consumer (patient). An 49-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 11May2021 16:45 (Lot Number: EW0182; Expiration Date: 31Aug2021) as 1st 0.3 ml single dose at the age of 49-years-old for covid-19 immunisation; testosterone cipionate, via an unspecified route of administration from 2020 (Lot Number: 88945; Expiration Date: 30Sep2021) and ongoing, at 150 mg, 2x/week (150 mg injection bi weekly ) for gonads, low testosterone. The patient medical history included low testosterone, gastrooesophageal reflux disease, COVID in the past (He did not know initially he had it, he had lost of taste and smell). Concomitant medication included dexlansoprazole (DEXILANT) taken for gastrooesophageal reflux disease from an unspecified start date and ongoing. None prior vaccinations (within 4 weeks). No family medical history relevant to AEs. No additional vaccines administered on same date of the pfizer suspect. The patient experienced anaphylactic reaction (medically significant) on 17May2021. Time of onset (24-hour clock): Roughly 18:00. Usually he took the testosterone in the morning, but he forgot. He was wrapping up the day, took the testosterone and by 18:02 he was on the ground, cold. The patient got his vaccination last Tuesday (11May2021). He was also on testosterone for gonadism. He usually administered the vaccine in his shoulders. He took the testosterone bi-weekly. On Monday he administered it his left shoulder and on Thursday it is in his right shoulder. After getting the vaccine he administered testosterone in his right shoulder on Thursday and had no issues. The patient mentioned everyone else who got the COVID Vaccine he knows had sore arm, nausea, but he did not have any of that. On Monday (17May2021) he injected his testosterone into the same arm/location, left arm, where he got the COVID vaccine and had an anaphylactic reaction. He contacted his doctor and went to the emergency room. The patient confirmed he felt like he had recovered completely from the anaphylactic reaction. Caller clarified the anaphylactic reaction. He did the testosterone injection in the same spot he had the COVID injection. Within 5 minutes it was like his skin was on fire. He was sweating, had stomach cramps, and was throwing up. Once he stopped throwing up he looked at his arms and saw they were solid red. They were all inflamed. His legs were inflamed. His hands swelled up. They were red. He had to take his wedding ring off. He was itchy. It was like he was on fire. He was sore, and sore where injected the Testosterone into left arm. He confirmed he had no problems swallowing or breathing. Based on the symptoms he was experiencing he realized these were things listed to be aware of when getting the COVID shot and to seek medical attention for. He went to the ER and they verified it was an anaphylactic reaction. Treatment included: He was given an Epi-Pen. It made him feel like off, like he had too much coffee or something. he was also given Benadryl and some Anti-Inflammatory to calm his body down. Investigations: He had blood drawn at the ER. However, he does not know if was actually tested. He was informed when the nurse drew blood it would be up to the doctor, but he has no knowledge if anything was done. Action taken of testosterone cypionate was dose not changed. Outcome of the events was recovered on 17May2021.
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| 49 | 2021-06-02 | seizure | seizure (one time) |
| 49 | 2021-06-05 | pain in extremity |
Arm alittle sore for less than a day. During the time dated on this report. Personality changed. Bec...
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Arm alittle sore for less than a day. During the time dated on this report. Personality changed. Became extremely agitated, paranoid, showed symptoms of a Mood Disorder such as Bipolar 1 or 2. Family noticed a significant change in personality and mood. Also some hallucinations mostly at nights. This all occurred suddenly with no explanation
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| 49 | 2021-06-07 | tingling |
per Spanish interpreter, pt had Pfizer vaccine, the 2nd dose on the 29th foot swollen and has hand ...
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per Spanish interpreter, pt had Pfizer vaccine, the 2nd dose on the 29th foot swollen and has hand tingling sx started on the 31rst, sx still present but improved vaccine given at marlin stadium lot number ew0153 first vaccine on may 8th no reaction
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| 49 | 2021-06-09 | facial paralysis, slurring |
Eye, cheek, and mouth droopy; Slurred speech; Lip numbness; This is a spontaneous report from a cont...
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Eye, cheek, and mouth droopy; Slurred speech; Lip numbness; This is a spontaneous report from a contactable nurse. A 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EK9231), intramuscular in left arm, on 19Feb2021 (at the age of 49 years), as second dose, single dose, for COVID-19 immunization. The patient's medical history included rosacea. There were no concomitant medications. The patient previously took the first dose of BNT162B2 (Lot Number: EK9231) on 29Jan2021 (at the age of 49 years) for COVID-19 immunization (intramuscular in left arm). The patient had no known allergies. The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. The vaccine was administered in a hospital facility. On 23Apr2021, the patient experienced lip numbness. On 24Apr2021, the patient experienced eye, cheek, and mouth droopy, and slurred speech. The adverse events resulted in emergency room or department or urgent care. The patient received treatment for the events including steroids and antivirals. The patient has not been tested for COVID-19 post-vaccination. The patient had not recovered from the events.; Sender's Comments: A possible contribution role of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of the reported events cannot be excluded considering temporal relationship. This case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 49 | 2021-06-09 | numbness, feeling cold, weakness, sensory loss, tingling, burning sensation |
Paresthesia starting in left arm especially along the outside of arm to the outside of hand and litt...
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Paresthesia starting in left arm especially along the outside of arm to the outside of hand and little finger. Progressed to affect both arms within several hours. Numbness, cold, burning sensations, tingling. Also feeling of weakness and slight loss of motor control. Symptoms continued to occur intermittently for around 6 days affecting the arms and legs along the outer part of the limbs. At one point I had almost no feeling in my lower legs. I still have numbness/loss of feeling in the outside portion of my left thigh which became worse after the second does of the vaccine, but has persisted since my first does of the same vaccine. I also experienced severe stiffness and strong pain in my spine. The pain affected different parts of my spine but the worst of it was concentrated in my lower back, which lasted several days.
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| 49 | 2021-06-10 | discomfort, weakness, burning sensation, feeling hot |
wife is reporting that his right arm felt like it was on fire and like he had hot fingers. About 30...
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wife is reporting that his right arm felt like it was on fire and like he had hot fingers. About 30 hours after taking the vax he felt hot at the core and felt like his breath was hot when he was breathing out. He went to PCP. had blood work with normal results. He has not developed chest pains and a feeling of heaviness on the left side of this body. He is feeling weak, tired and BP is elevated. He went to medical facility. He had a CTA. He was discharged to go home and FU w/ PCP where the test results were sent.
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| 50 | 2021-01-01 | pain in extremity |
Had chills, body aches, and low grade fever starting approximately 14 hours after vaccination. Sym...
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Had chills, body aches, and low grade fever starting approximately 14 hours after vaccination. Symptoms continued off/on for approx. 16 hours. Treated with Tylenol and Ibuprofen without any further issues. Arm was quite sore also for a day and a half.
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| 50 | 2021-01-04 | flushing |
2 min after shot became dizzy, flushed, sweaty. Lasted 6-7 min. Arm soreness and extreme tiredness b...
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2 min after shot became dizzy, flushed, sweaty. Lasted 6-7 min. Arm soreness and extreme tiredness both for two days. Next day developed itching that progressed over several days. Rash/hives to upper chest, arms, and back started on day 3 after injection. Had to take Benadryl and vistaril initially then Doctor prescribed Prednisone on day six.
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| 50 | 2021-01-04 | tingling | Patient reported tingling in her fingers but reported she was fine by 3:06pm |
| 50 | 2021-01-05 | weakness |
Cough; Flu like symptoms; It hurts to walk; I have a stuffed up nose, I did not have it yesterday; P...
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Cough; Flu like symptoms; It hurts to walk; I have a stuffed up nose, I did not have it yesterday; Pale; I felt weak; Bones ache; Have not been feeling good; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch Number and Expiration Date unknown) via an unspecified route of administration on 28Dec2020 at single dose on arm for suppress the COVID-19 (COVID-19 immunization). The patient's medical history included blood pressure, stomach ulcer and psoriatic arthritis. The concomitant drug was reported as colecalciferol (VITAMIN D), potassium citrate, multivitamin, etanercept (ENBREL) at once a week, pen shot in stomach, omeprazole (PROTONIX) at once a day for stomach ulcer and blood pressure medications. The patient was a correction officer, patient work at the prisons in (state name) and were given vaccination of Pfizer on Monday and he did that on Monday and have been getting sick and it's getting worse everyday, so yesterday at work everything was fine and he went home at 8 'O' clock at night because he was getting pale, felt weak, bones ache and have not been feeling good and today he called it in because he woke up with the cough, flu like symptoms. And it's worse today than it was yesterday. Consumer stated today, bones ache was worsening of like weaker, it hurts to walk and bone ache was really, today was worse than yesterday for the bone. Today flu like symptoms was worse, today patient have more heavier cough, was coughing more today and have a stuffed up nose, I did not have it yesterday. Wanted to know if this was a side effect or is that normal with that vaccine. Start date of events was on 28Dec2020. When patient started feeling some symptoms that started getting progressively worse on 29Dec2020. Treatment included Tylenol for bone pain and hurts to walk. Lab test blood work done in Dec2020, once a month through psoriatic arthritis doctor. The outcome of events, weak, Bone pain, Cough, Flu like symptoms, was not recovered. The outcome of other events was unknown. Information on Lot/batch number has been requested.
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| 50 | 2021-01-05 | flushing, tingling |
1011-2nd Dose of Pfizer administered; 1025 pt began feeling a quivering in his stomach about where h...
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1011-2nd Dose of Pfizer administered; 1025 pt began feeling a quivering in his stomach about where his diaphragm is located. the feeling went away and pt went back to his office. 1045-Symptoms began again flushed/faintness accomapanied the initial quivering. Pt bean feeling tingling his fingers and toes and felt like a lump was in his throat, his neck felt tight. 1052-Reported back to COVID pop up vaccine clinic reporting symptoms to staff in the clinic. 1100-BP 200s/90s HR 110s SPO2 96%. pt interviewed by lead FNP and evaluated. PT given water and granola bar as he reported he did not eat that morning, only took Excedrin. 1115-BP 165/86 HR 92 SPO2 98%RA. pt reports symptoms starting to resolve. 1120-HR 84 SPO2 98%RA. 1122-Pt dc'd to work. pt asked to not leave the hospital for 4-6 hours, not even to work offsite. pt agrees to report to ED if symptoms return.
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| 50 | 2021-01-05 | flushing | Neck and Face flushing. Tachycardia with rate of 120 for 1.5 hours. |
| 50 | 2021-01-06 | weakness |
Headache, Fever, fatigue, weakness, sore throat Narrative: 12/29 - received vaccine. 12/30 - woke up...
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Headache, Fever, fatigue, weakness, sore throat Narrative: 12/29 - received vaccine. 12/30 - woke up with a fever and scratchy throat and headache. Since then the symptoms have lingered. Jan 2- 3 he developed more fatigue. Jan 4 - fever to 101 and headache. He also feels weak and has intermittent scratchy throat. Also had injection site soreness. He has Rheumatoid Arthritis for which he's taking actimira, and methotrexate (immunesupressants). Will test him today (1/4) for COVID-19. 1/5 - COVID-19 test is negative. Employee reports resolution of all symptoms.
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| 50 | 2021-01-06 | tingling |
Patient received Pfizer Covid 19 vaccine at 1400. He felt fine initially. At 1600 developed lighthea...
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Patient received Pfizer Covid 19 vaccine at 1400. He felt fine initially. At 1600 developed lightheadedness, slight headache and intermittent tingling to his left fingers. He reports itching to his extremities. He has not noticed a rash. He denies syncope, nausea, vomiting, sore throat, congestion, chest pain, SOB, palpitations, weakness, slurred speech, abdominal pain, diarrhea. He denies history of prior allergic reactions. No new medications. he is not anxious. Denies rash likely related to vaccine administration at 1400; seen in the urgent care at 1600 and discharged after treatment and evaluation at 1858. Inventions: ekg no acute findings; methylPrednisonolone 125 mg IV; diphenhydramine 25 mg IV; famotidine 20mg po; odansetron 4mg IV home with Benadryl 25 mg Q6 hours for 5 days.
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| 50 | 2021-01-07 | flushing |
he dust that landed on his face caused hives; feeling flushed; started feeling itchy about 2 hours p...
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he dust that landed on his face caused hives; feeling flushed; started feeling itchy about 2 hours post vaccine; This is a spontaneous report from a contactable nurse. A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EK5730, intramuscular from 23Dec2020 11:00 at a single dose for COVID-19 immunization. Medical history included patient's known allergies: Only grass, pollen, dust mites; and hives all from unspecified dates. Concomitant medication included naproxen sodium (ALEVE) for " itchy", ibuprofen (MOTRIN) and paracetamol (TYLENOL 8 HOUR). The patient got the COVID vaccine on 23Dec2020 at 11:00. He stayed at vaccination location for 30 minutes and then drove to his destination. Upon arrival at 12:00, he started feeling flushed. No shortness of breath or breathing difficulties. He then started feeling itchy about 2 hours post vaccine. He took an Aleve. At home in the evening, took Benadryl with improvement of symptoms. The following day he also took Benadryl. On 25Dec2020 & 26Dec2020, he still had some itching, but not bothersome enough to take medications. On 27Dec2020 he was working cutting tile and wearing protective eye wear, but the dust that landed on his face caused hives. He has been taking Benadryl since. He said that this has occurred in the past when his body was hypersensitive, the hives. He has seasonal allergies but no allergies to food/medications/vaccines. Patient was not diagnosed with COVID-19 and since the vaccination, he has not been tested for COVID-19.
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| 50 | 2021-01-07 | pain in extremity |
Sore arm for day and a half; onset of chills, body aches, low grade fever.; onset of chills, body ac...
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Sore arm for day and a half; onset of chills, body aches, low grade fever.; onset of chills, body aches, low grade fever.; onset of chills, body aches, low grade fever.; This is a spontaneous report from a contactable nurse (patient). A 50-year-old male patient receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: EL0142), via an unspecified route of administration on the right arm on 31Dec2020 07:45 at SINGLE DOSE for COVID-19 immunization at the hospital. There were no concomitant medications. It was reported that the patient was the patient diagnosed with COVID-19 prior to vaccination on 12Dec2020 (pending clarification). On 31Dec2020 22:00 (approximately 14 hours after vaccination), the patient had a sore arm for day and a half and onset of chills, body aches, low grade fever were noted. It was mentioned that the symptoms were treated with acetaminophen (TYLENOL) and ibuprofen. The patient was not tested for COVID-19 since the vaccination. The patient recovered from sore arm on 02Jan2021 10:00 (day and a half) and from the remaining events on 01Jan2021 14:00 (lasted for approx. 16 hours off/on).
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| 50 | 2021-01-08 | flushing |
12 minutes after receiving the 2nd covid vaccination, I felt flushed and became diaphoretic. I felt ...
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12 minutes after receiving the 2nd covid vaccination, I felt flushed and became diaphoretic. I felt heart palpitations and checked my heart rate which was 117, increasing to a max of 123. I was placed on a pulse ox monitor, which showed 93%, BP was elevated at 146/85. I was not given any medical treatment, and was placed on a monitor for one hour. Once my hr and 02 stas were at my baseline, I was allowed to be discharged. I went back to my department and decided to go home, as I felt tired and was mildly nauseous.
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| 50 | 2021-01-08 | numbness |
Left sided facial numbness 36 hours Dizzy spells 36 hours Fatigue 58 hours and counting body aches 4...
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Left sided facial numbness 36 hours Dizzy spells 36 hours Fatigue 58 hours and counting body aches 48 hours headache 36 hours stabbing pain 36 hours
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| 50 | 2021-01-10 | flushing |
Patient experienced lip swelling, tachycardia and flushing after vaccine administration. Patient was...
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Patient experienced lip swelling, tachycardia and flushing after vaccine administration. Patient was evaluated and treated in the ER and has been discharged at this time.
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| 50 | 2021-01-11 | feeling hot, hot flush, flushing |
Patient hot and flushed in the head, face, neck, and back area. It was disappears after 10 minutes....
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Patient hot and flushed in the head, face, neck, and back area. It was disappears after 10 minutes. The patient was given Benadryl 25mg as a precaution.
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| 50 | 2021-01-11 | flushing |
0811 - pt c/o lightheaded and flushing. Pt reports I feel like I am going to pass out. Pt assisted...
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0811 - pt c/o lightheaded and flushing. Pt reports I feel like I am going to pass out. Pt assisted to stretcher. BP - 131/83, hr 87, rr 22, sats 100. Pt given water. 0813 - Pt reports "I am feeling normal.: 0814 - 120/79, p 74, rr 20, sats 99 0818 - Pt clearing throat. Pt states this happened with first vaccine. Pt states "I feel a tickle in my throat." Pt unable to take Benadryl pills. 0820 - Pt given 25 mg liquid Benadryl 0828 - bp 137/85, hr 67, rr 18, sats 98.. Pt reports I feel better. Pt assisted to chair. 0835 - Walked in hallway with patient. Pt reports I feel normal. 0840 - Pt walked to door. Denies throat tickle, being lightheaded or flushed.
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| 50 | 2021-01-11 | tingling, weakness |
Shortness of breath on exertion; weakness; fatigue; chills; tingling sensation of extremities that c...
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Shortness of breath on exertion; weakness; fatigue; chills; tingling sensation of extremities that continues on; This is a spontaneous report from a contactable healthcare professional, the patient. A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EK9231) solution for injection intramuscular on 21Dec2020 (at the age of 50-years-old) as a single dose for COVID-19 vaccination. Medical history included neuropathy. Concomitant medication included gabapentin. Past drug history included known allergies: TOPAMAX. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 27Dec2020, the patient experienced fatigue, chills, tingling sensation of extremities that continues on. Treatment for the events fatigue, chills, tingling sensation of extremities included ibuprofen (MOTRIN) and acetaminophen (TYLENOL) taken with minimal or short temporary relief. On 30Dec2020, the patient experienced shortness of breath on exertion and weakness and tried to go to Urgent care clinic for Covid test but no available test so the doctor prescribed ZITHROMAX in case it was Covid. On 30Dec2020, MRI, XRAY, LABS were taken and all came back negative and normal except having all these symptoms. On 02Jan2021, Covid test done and result was negative, tested for antibody and it was positive. The outcome of the event fatigue was unknown. The outcome of the events chills and tingling sensation of extremities was recovered in Jan2021. The outcome of the events shortness of breath on exertion and weakness was not recovered. The events fatigue, chills, tingling sensation of extremities that continues on, shortness of breath on exertion and weakness required a physician office visit.
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| 50 | 2021-01-13 | weakness |
Feverish feeling and chills with myalgias and weakness at 4am on 12/18/2020. Took 800mg advil and 10...
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Feverish feeling and chills with myalgias and weakness at 4am on 12/18/2020. Took 800mg advil and 1000mg tylenol. Felt perfect by 7 am. Despite this, fearing covid, I did not go to work, was rapid trsted covid negative that day and pcr tested that day retirning negative 2 days later. Days later I began to have vague nagging chest pain with occasional sharp chest pain over my heart. I had what I would describe as chest tightness in addition in which it felt hard for me to expand my chest fully like pressure without being short of breath. This would last at most several minutes and perhaps occurred three or four times over a seven day period. Throughout this. I could exercise with no chest pain no increasing shortness of breath, including a PR on Peloton and two hours of tennis without cardiac symptoms. Yesterday, my smart internist heard a split S2 heart sound as I lay on my left side and held my breath; the EKG showed a depressed PR interval ad some ST elevstions consistent with pericarditis, which I am treating with motrin. I assume this is a viral pericarditis. I had two types of Covid tests during that time period. My second dose of the vaccine was January 8. The feverish feeling occurred before dose 2, as did some of the chest oains and tightness.
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| 50 | 2021-01-13 | flushing, tenderness | Anaphylactic reaction - swollen lips, dizziness, flushing, rapid heart rate |
| 50 | 2021-01-13 | muscle spasms |
Moderate severe headache, chills, muscle aches and muscle spasms/cramps. Severe enough to keep me i...
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Moderate severe headache, chills, muscle aches and muscle spasms/cramps. Severe enough to keep me in bed the following day.
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| 50 | 2021-01-14 | weakness, night sweats |
1/12/2021 @ 2200hrs - Muscle/body aches, injection site tenderness 1/12/2021 @ 2300hrs - Muscle/body...
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1/12/2021 @ 2200hrs - Muscle/body aches, injection site tenderness 1/12/2021 @ 2300hrs - Muscle/body aches, chills 1/13/2021 @ 0300hrs - Muscle/body aches, chills, fever of 99.0, general malaise 1/13/2021 @ 0600hrs - Muscle/body aches, chills, tired, no energy, difficult to get out of bed. Did not go to work. 1/13/2021 @ 1000hrs - Symptoms continued. Advil 600mg PO taken. Allowed sleep from 1030-1230hrs. 1/13/2021 @ 1230hrs - Woke up feeling damp as if having had night sweats. Rested the entire day. 1/14 to 1/15/2021 - Left arm site tenderness with raised hard area at site of injection. Left armpit raised/swollen, appears as lymphadenopathy.
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| 50 | 2021-01-18 | flushing | facial and eye flushing, hot breath |
| 50 | 2021-01-18 | numbness, tingling |
C/O felling numbness in the back of his head and some tingling in left arm. Seen By EMT. BP-131/91,7...
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C/O felling numbness in the back of his head and some tingling in left arm. Seen By EMT. BP-131/91,76. O2 Sat 98%. TEl./EKG SR.
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| 50 | 2021-01-19 | pain in extremity |
on the night of 1/5/2021, headache and right arm pain. starting in the pm on 1/16/21 vomiting starte...
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on the night of 1/5/2021, headache and right arm pain. starting in the pm on 1/16/21 vomiting started and lasted through Tuesday 1/19/21. As of today lasting symptom is fatigue.
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| 50 | 2021-01-19 | pain in extremity |
the night of the vaccine, headache and arm pain started. On Saturday 1/16/21 vomited started and las...
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the night of the vaccine, headache and arm pain started. On Saturday 1/16/21 vomited started and lasted until Tuesday 1/19/21. Continues to feel fatigue today on 1/20/21.
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| 50 | 2021-01-20 | muscle spasms |
I expeirienced Body aches and cramoing. It was not sharp pains like cramping but a dull pain and was...
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I expeirienced Body aches and cramoing. It was not sharp pains like cramping but a dull pain and was very stift/sore till next day, approx 18 hours. Mild headache
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| 50 | 2021-01-25 | numbness |
numbness in his right hand; This is a spontaneous report from a contactable pharmacist (patient hims...
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numbness in his right hand; This is a spontaneous report from a contactable pharmacist (patient himself). A 50-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; lot number: EH9899, expiration date was unknown), intramuscularly on the right arm on 18Dec2020 at 12:00 at a single dose for COVID-19 immunization administered at the hospital. The patient had no medical history. He had no known allergies. There were no concomitant medications. The patient had no other vaccine in four weeks and had no other medications in two weeks. The patient had no Covid prior to vaccination. He was not tested for Covid post vaccination. On an unspecified date, following the first vaccine, the patient had numbness in his right hand for two (x2) days. The patient did not receive any treatment for the event. The patient recovered from the event "numbness in his right hand" on an unspecified date.
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| 50 | 2021-01-26 | muscle spasms, weakness | Malaise, weakness, muscle cramps fatigue. |
| 50 | 2021-01-27 | burning sensation, pain in extremity |
Date these symptoms started was 1/27/2021: About 12 hours after injection, developed fatigue and sl...
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Date these symptoms started was 1/27/2021: About 12 hours after injection, developed fatigue and slight nausea as expected. Oral temperature 98.0. Commuted to work without issue. ~ 1400: As day progressed, nausea subsided, but fatigue grew more profound and developed pain in the right subscapular area with exertional shortness of breath walking any length of time. (Injection of initial and second doses were both in right deltoid). 1540 - 1800: Fatigue increased, developed a burning/tearing pain with every yawn and deep breath from the top of my trachea into both left and right mainstem bronchi and radiated to right arm. It literally felt like someone was trying to tear out my bronchial tree with each breath. 1800: Arrived home and medicated self-medicated with Motrin 400mg. 1800 -2030: rested at home with still some breathing pain, no shortness of breath, but incredibly tired. 2045: Went to bed and slept for the next 12.5 hours without any issued during the night. 0800: Woke up nearly all symptoms were gone, only some minor residual fatigue. No breathing pain, no nausea, no subscapular pain. I did not seek medical attention for symptoms, nor did I contact my provider. I experienced fatigue and a headache with the first dose, but no other symptoms. I never experienced fever or chills
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| 50 | 2021-01-27 | numbness | Numbness right side of face and gums. Rash on arms. |
| 50 | 2021-01-27 | pain in extremity | Red sore arm, body aches, and head ache |
| 50 | 2021-01-28 | numbness, facial pain |
fever; my lighter weight facial fillers swelled and were painful (around the eyes - not my lip fille...
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fever; my lighter weight facial fillers swelled and were painful (around the eyes - not my lip fillers); my lighter weight facial fillers swelled and were painful (around the eyes - not my lip fillers); numbness in both hands; This is a spontaneous report from a contactable pharmacist (patient). A 50-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK4176, expiration date not reported), intramuscular on the left arm, on 07Jan2021, at 11:30 at a single dose for Covid-19 immunization. The patient has no medical history and no known allergies . There were no concomitant medications. The patient previously took the first vaccine of bnt162b2 on 18Dec2020, at 12:00 PM, Intramuscular, on the Right arm for Covid-19 immunization, he had numbness in his right hand x2 days. On 09Jan2021, following second dose, he has had numbness in both hands x2 days and on 10Jan2021, day 2, he ran a fever and his lighter weight facial fillers swelled and were painful (around the eyes - not my lip fillers). His eyes have a mix of Juvaderm products. It spontaneously resolved after 1 day with a subjective loss in overall volume. Density of the product used seemed to be a factor in the response. He knows this has been reported with the Moderna product, but he does not believe is has been reported with our product. It appears the response may not be product specific, but more specific to the type of vaccine. The patient has no Covid prior vaccination and not covid tested post vaccination. No treatment was received for the events. Outcome of the events was recovered in Jan2020.
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| 50 | 2021-02-01 | flushing | Patient felt flushed and nauseous. |
| 50 | 2021-02-02 | pain in extremity |
6 hours after shot, arm was in pain where i could hardly move, by morning felt like i had flu, by mo...
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6 hours after shot, arm was in pain where i could hardly move, by morning felt like i had flu, by mon afternoon temperature went up to 101.8 before dropping tues evening.
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| 50 | 2021-02-02 | seizure | Seizure unilateral right side, less than 2 mins. 2 times post injection. |
| 50 | 2021-02-04 | numbness |
Numbness in the cheeks, lips and the tongue; Numbness in the cheeks, lips and the tongue; Numbness i...
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Numbness in the cheeks, lips and the tongue; Numbness in the cheeks, lips and the tongue; Numbness in the cheeks, lips and the tongue; This is a spontaneous report from a contactable consumer (patient). This 50-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot# SL3247), via an unspecified route of administration on 22Jan2021 at single dose for COVID-19 immunization. The patient's medical history included ongoing thyroid. The patient's concomitant medications included thyroid (ARMOUR THYROID) for thyroid. Patient had a COVID 19 vaccine on 22Jan2021 and had couple of side effects with the numbness in the cheeks, lips and the tongue in Jan2021. No treatment received. Outcome of the events was unknown. No investigation assessment.
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| 50 | 2021-02-08 | pain in extremity |
left hand swelling. entire hand and fingers. not arm or lymph nodes. just hand. painful and difficul...
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left hand swelling. entire hand and fingers. not arm or lymph nodes. just hand. painful and difficult to make a fist and bend fingers
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| 50 | 2021-02-09 | pain in extremity, weakness |
sore arm; lack of energy; Headaches on occasion.; This is a spontaneous report from a contactable co...
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sore arm; lack of energy; Headaches on occasion.; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: El1283), via an unspecified route of administration in the left arm on 18Jan2021 14:00 at a single dose for covid-19 immunization. The patient has no medical history and concomitant medications. On 19Jan2021 06:00, the patient reported sore arm, noticeable lack of energy and headaches on occasion. The patient does not have covid prior vaccination and had not tested positive post vaccination. The patient did not receive treatment for the events. The outcome of the events was not recovered.
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| 50 | 2021-02-09 | pain in extremity |
arm was sore; This is a spontaneous report based on the information received by Pfizer. (Case Number...
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arm was sore; This is a spontaneous report based on the information received by Pfizer. (Case Number: 01845505). A non-contactable consumer (Wife) reported 50-year-old male patient that: Description: Voicemail left on PIR line on 14Jan2021 at 10:29 PM. She learned of from her husband, on the Pfizer COVID-19 vaccine. He had his first vaccine on 13Jan2021 and on 14Jan2021 reported that his arm was sore, "really really sore like he had been punched in the arm". There is not permission to contact the patient about this report. No PQC reported. Physical information: Product: Pfizer Covid-19 vaccine Product circular#: N/A Lot number: EL3249 Expiration date: Unknown by reporter Dose/ frequency: single dose No follow-up attempts are possible. No further information expected.
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| 50 | 2021-02-14 | discomfort |
body aches/chills/headache/lymphadenopathy L sided (side of injection) - all resolved except of sign...
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body aches/chills/headache/lymphadenopathy L sided (side of injection) - all resolved except of significant Left axillary lymphadenopathy - swelling was the size of small melon, non-tender, rather uncomfortable. Next day, it got a bit smaller - about size of large fist, but still present, day 4. Post auricular and posterior cervical Left lymph nodes were also enlarged and tender, but not to the same extend.
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| 50 | 2021-02-14 | tingling |
Pfizer-BioNTech COVID-19 Vaccine: About 15 minutes after vaccination, patient started to feel that ...
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Pfizer-BioNTech COVID-19 Vaccine: About 15 minutes after vaccination, patient started to feel that there is a lump in his throat and both hands had tingling. Paramedic was on site and put patient on EKG monitor and observed patient for 20 minutes. The patient left the site independently and stated no further issues.
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| 50 | 2021-02-17 | flushing |
delirium; Fever of 100.8; chills; flushed; overall soreness; deltoid pain; This is a spontaneous rep...
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delirium; Fever of 100.8; chills; flushed; overall soreness; deltoid pain; This is a spontaneous report from a non-contactable consumer. A 50-year-old male patient received BNT162B2 (lot# unknown) on 03Feb2021 01:30 PM at single dose for covid-19 immunization. Medical history and concomitant drug were not reported. Patient experienced Fever of 100.8, chills, flushed, overall soreness, delirium, and deltoid pain on 04Feb2021 04:00 AM with outcome was Recovering. No covid prior vaccination. No covid tested post vaccination. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 50 | 2021-02-22 | flushing |
Flushed, pale, diaphoretic, bradycardic. Epi administered and RRT called. Admitted to hospital with ...
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Flushed, pale, diaphoretic, bradycardic. Epi administered and RRT called. Admitted to hospital with cardiac cath - likely unrelated.
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| 50 | 2021-02-23 | numbness and pain in extremities | B12 deficiency, identified via neuropathy. |
| 50 | 2021-02-25 | pain in extremity |
Little back problems, lower back; hurts(Back); My arm is hurting; my arm was killing me; my arm hurt...
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Little back problems, lower back; hurts(Back); My arm is hurting; my arm was killing me; my arm hurts; I throw up twice yesterday; I got a little sick; I just got a little chill; I got chills on the lower part of my back; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:EL3247), via an unspecified route of administration at the age of 50 years, on 25Jan2021 at a SINGLE DOSE for covid-19 immunisation. Medical history was reported as none. There were no concomitant medications. The patient stated, "Yesterday I took my second vaccine shot and my side effects this morning was a little back problems, lower back, my arm is hurting, and I throw up twice yesterday, I got a little sick. So, I just wanted to call and let somebody know." It was also stated, "Yesterday when I got home after the shot, I just got a little chill and then I laid down, I throw up twice and I just laid down and laid down. And when I woke up I was calling you all since 1 in the morning because my arm was killing me." It was stated, "Yes, my arm hurts and my back, I am in my house and I got the back thing on for, the heating pad (treatment), just for my back." The consumer stated, "I took aspirin because I throw up twice yesterday so I just took aspirin. And then I was laid down and I woke up this morning and I took one in the morning. I have been trying to call you all morning, all morning I just got, just to let you know that my arm is hurting and I got a chills on the lower part of my back." Therapeutic measures were taken as a result of little back problems, lower back; hurts(back) (back pain), i throw up twice yesterday (vomiting). The outcome of the events was not recovered.
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| 50 | 2021-02-26 | bell's palsy |
I received 2nd dose of vaccine on Jan 11. On the date above I developed eye irritation. The next...
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I received 2nd dose of vaccine on Jan 11. On the date above I developed eye irritation. The next day I couldn?t blink that eye and was diagnosed with Bells Palsy.
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| 50 | 2021-02-28 | numbness |
About twenty minutes after the injection, I was walking to the transit and my legs felt a little bit...
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About twenty minutes after the injection, I was walking to the transit and my legs felt a little bit numb (but not tingly) I thought maybe it was nerves. About 25 minutes after the injection, I was concerned (possibly too anxious) and I decided to return to the site. I crossed the bridge and sat down at the bridge gate. The personnel there called an EMT, and about 15 minutes later the EMT came to talk to me and take my blood pressure and pulse Oxygen. Blood pressure was 137 - 87. Pulse Ox was 100%. By that time I had calmed down the sensation in my legs had eased. Approximately 2 hours after the injection I began to feel soreness in my joints (and this did not pre-occupy me, since I knew that feeling the beginning of aches and pains a couple hours after injection is normal). It is now 6 hours and 32 minutes after the injection, and I am feeling ok. It was quite probably anxiety on my end. The folks in city were very nice to me at the pedestrian bridge gate. I have noted talking the EMT below as health professional visit, I also plan to go see Dr. prior to the 2nd shot.
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| 50 | 2021-03-03 | numbness |
The evening of the 2nd vaccine started having numbness in left shoulder and progressed to hand. The...
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The evening of the 2nd vaccine started having numbness in left shoulder and progressed to hand. Then numbness also affected left side of face and neck and left anterior chest wall. Intermittent pain in chest wall with intermittent resolve of numbness. The worst of it lasted a week. After a week, numbness started to resolve, but still have residual numbness in left hand. Did have headaches as well for that week and then headaches resolved after a week.
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| 50 | 2021-03-03 | tingling |
I have experienced low-level numbness/tingling in my left hand; primarily in my thumb and index fing...
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I have experienced low-level numbness/tingling in my left hand; primarily in my thumb and index finger. Range of motion has been normal. No pain either. Strangely it began 1 week after my first injection. It was intermittent in the time after that and before the 2nd injection. On the day of the second injection I experienced renewed symptoms in the same hand immediately after receiving my 2nd dose. I spoke with the attending physician at the time and was told that she had heard about some instances of numbness but it would probably fade with time. Unfortunately I am now over 2 weeks since the second dose was administered and my symptoms have been nearly constant and do not appear to be waning.
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| 50 | 2021-03-04 | tingling |
About an hour after the shot, I felt some tingling in my face; that was followed by a few odd sensat...
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About an hour after the shot, I felt some tingling in my face; that was followed by a few odd sensations, all of which are basically the same as when I have a flu shot. Eight hours after the shot, I noticed that I was smelling smoke; my sense of smell started to do weird things an hour before (for example, smelling rotten food in the fridge), but this became clear when the smoke smell started. Over the first 48 hours, my left arm was sore (sore to touch at 24 hours, gone at 48), and I had some mild flu symptoms (sore throat, stuffy nose, fatigue), plus some chest "tightness" which I have been feeling from time to time since March 2020. The flu-like symptoms were all basically gone except the stuffy nose. I still have a slight stuffy nose, and the strange smell issue. I have been able to smell things fine all along, it's just overlaid with a smell that started as smoke or BBQ, and varies in strength; it's a bit like smelling dirt now. It's always possible this is coincidental, but I wasn't exposed to smoke or anything that I think could cause my nose to go haywire.
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| 50 | 2021-03-06 | tingling, slurring |
Initial confusion upon waking at 7AM. Uncomfortable but unable to determine why. Tried to re-arrange...
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Initial confusion upon waking at 7AM. Uncomfortable but unable to determine why. Tried to re-arrange pillows but could not get arms to complete the process even though fully mobile. A minor amount of weakness in arms/legs and tingling across the lower face, particularly on the right side. Once up, had an inability to form words even though thoughts were coherent. Minor difficulty swallowing water. Speech slurred badly enough to be incomprehensible to my wife. By 7:30 we arrived at the hospital where symptoms were improving.
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| 50 | 2021-03-06 | tenderness |
Testicular pain and tenderness in the left testicle. There is no redness and only slight swelling. T...
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Testicular pain and tenderness in the left testicle. There is no redness and only slight swelling. The pain was focused on the back side of the left testicle and radiated up the inguinal canal into the abdomen. It was present on palpation and intermittently without palpation. Pain came on quickly and subsided over 24 hours. No penile discharge, fever, or other signs were present.
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| 50 | 2021-03-08 | seizure |
Friday at 1:30 (3/5 my husband received the first shot. That evening he wasn't feeling well at all. ...
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Friday at 1:30 (3/5 my husband received the first shot. That evening he wasn't feeling well at all. Went to sleep in the morning on 3/6 he still was feeling horrible. Looked gray in color- thought he was getting the flu. At 2AM I woke to him having a seizure. Followed by another seizure at 10AM ( 3/7) followed by another seizure at 3PM (3/7) followed by another seizure at 3AM (3/8) and another seizure at 6:30 AM on (3/8).
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| 50 | 2021-03-09 | pain in extremity |
Pain at injection site. Achy body. **Severe pain in my left hip and down my left leg. Unable to walk...
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Pain at injection site. Achy body. **Severe pain in my left hip and down my left leg. Unable to walk without severe limp and pain.**
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| 50 | 2021-03-10 | numbness |
Within 5 hours of receiving the shot my entire right arm was numb and tingly and my pinky finger fel...
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Within 5 hours of receiving the shot my entire right arm was numb and tingly and my pinky finger felt like it wasn?t there. I also has the worst headache of my life, ibuprofen didn?t help it. The next morning (Friday) I felt somewhat better but by noon, I felt just as bad as the night before and the horrible headache was back. Saturday and Sunday were exactly like Friday. Monday morning, my arm was back to normal and the horrible headache was gone. Since them I?ve had headaches on and off, but not as horrible as Thursday thru Sunday. This afternoon marks 1 week since my first of 2 doses. I?m not sure at this point if I want to get the 2nd dose or not when it?s due.
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| 50 | 2021-03-11 | feeling hot |
Pt states he felt a flush of warmth through his body for 10 minutes. Had a drink water, take off hi...
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Pt states he felt a flush of warmth through his body for 10 minutes. Had a drink water, take off his jacket and wait. Seen by NP, symptoms resolved. VSS @ 1400 BP 170/98, Pt has history of High blood pressure but did not take medications. HR 88, O2Sat 98%, T: 97.5F. VSS @ 1420 Discharge, T: 97.5, HR 86, OSat 99%
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| 50 | 2021-03-11 | tingling | Swelling and tightness of right side of face (cheek), right leg paresthesia. |
| 50 | 2021-03-12 | seizure | Had seizure in car when leaving the facility, about 1/2 hour after the vaccination. |
| 50 | 2021-03-15 | tingling, burning sensation |
Approximately 3 days after the injection I had a bad breakout of acne on my scalp and on my temples....
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Approximately 3 days after the injection I had a bad breakout of acne on my scalp and on my temples. I went to the dermatologist and this was treated with Doxycycline Hyclate. The bad breakout of acne cleared up in about 1-1.5 weeks. At the two week mark I started to have a burning sensation near my left eye that felt like a sunburn or some nerve tingling. I interpreted this to potentially be the early signals of shingles so I started taking Valtrex. I will take a 1,000 mg dosage of Valtrex twice a day for 7 days to treat this. I had the Shingrex vaccine on 12/19/19 and 4/29/20. I feel like both of these issues were potential side effects from the Covid vaccine.
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| 50 | 2021-03-16 | weakness |
Client had syncopal episode, diaphoretic, n/v assessed by Lead RN & EMS , EMStransported client for...
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Client had syncopal episode, diaphoretic, n/v assessed by Lead RN & EMS , EMStransported client for hypotension and weakness.
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| 50 | 2021-03-16 | flushing, tremor, tingling |
Tingling up left shoulder, neck and head approximately 1 minute post injection. Followed by flushi...
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Tingling up left shoulder, neck and head approximately 1 minute post injection. Followed by flushing, nausea and trembling. Approximately 5-7 minutes post injection experienced onset of difficulty swallowing and rapid heartbeat. 10-12 minutes post injection sensation of throat closing with some difficulty breathing, difficulty swallowing increased. 15-17 minutes post injection, paramedics arrived. Blood pressure was 169/113. Dizzy upon standing. 20 minutes post injection paramedics administered 50mg Benadryl due to difficulty swallowing and sensation of throat closing however it wasn?t worsening. Paramedic asked me to rate the swallowing difficulty (1-10) which was a 5-6 but never exceeded that. Transported to Emergency Room.
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| 50 | 2021-03-17 | pain in extremity | A lot pain in my arms Stomach discomfort |
| 50 | 2021-03-18 | flushing, weakness | Flushed, sweating, ?fever feeling?, altered vision, weakness |
| 50 | 2021-03-18 | numbness |
3-17-21 6:30PM 'A LITTLE NUMBNESS TO RT FOREARM'. PTP INDICATES ANTERIOR ASPECT. MOTOR AND SENSORY I...
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3-17-21 6:30PM 'A LITTLE NUMBNESS TO RT FOREARM'. PTP INDICATES ANTERIOR ASPECT. MOTOR AND SENSORY INTACT; NO DEFICIT NOTED. CAP REFILL GOOD. BOTH ARMS PINK, W/D. EQUAL STRENGTH AND GRIP NOTED. NO ACUTE OR OBVIOUS DISTRESS NOTED.
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| 50 | 2021-03-19 | pain in extremity |
Started with sore arm 10 hrs after shot, then body aches, headache, chills started around 11pm(12 ...
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Started with sore arm 10 hrs after shot, then body aches, headache, chills started around 11pm(12 hrs after) My normal temp us about 97.8 it was up to 99 at 1am Nausea started around then. Dry mouth, by 3am temp was 99.9, vomited 3 times by 4am and temp went to 100.3 20 min later it was 99.6 at 8am i still had massive headache, temp iup to 101, still chills and sweats, nauseous Well it was 101, now 99 in just 20 min Nausea subsided enough to take Acetaminophen Temp around 100 till mid afternoon. Headache continued. Was able to eat dinner. Around then most symptoms stopped except headache and itchy skin Btw i had covid 7/2020
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| 50 | 2021-03-19 | pain in extremity | right arm pain |
| 50 | 2021-03-19 | tremor | Light headed Stomach upset Headache Passed out and shook on the ground Called paramedics |
| 50 | 2021-03-21 | numbness, tingling, bell's palsy |
left side of face just under cheek bone feels slightly numb and tingly, left side of mouth appears v...
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left side of face just under cheek bone feels slightly numb and tingly, left side of mouth appears very, very, very, slightly "drooped" like it does not match the right side of my mouth; left side of face just under cheek bone feels slightly numb and tingly, left side of mouth appears very, very, very, slightly "drooped" like it does not match the right side of my mouth; left side of face just under cheek bone feels slightly numb and tingly, left side of mouth appears very, very, very, slightly "drooped" like it does not match the right side of my mouth; This is a spontaneous report from a contactable consumer (patient himself). A 50-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 06Mar2021 15:45 (at age of 50-year-old) (Lot Number: EN6206) as single dose for COVID-19 immunization. Medical history included high blood pressure, high cholesterol, obesity. There was known allergies: bee stings and sulfa drugs. Concomitant medications included atorvastatin (LIPITOR); hydrochlorothiazide, lisinopril (LISINOPRIL HCTZ); and emtricitabine, tenofovir disoproxil fumarate (TRUVADA). The patient reported "left side of face just under cheek bone feels slightly numb and tingly, left side of mouth appears very, very, very, slightly 'drooped' like it does not match the right side of my mouth but you have to stare and look really close to notice it. Should I hold off on getting my second dose in the next 3 or 4 weeks to see how this goes?" The adverse events start time was 06Mar2021 20:45. The events did not result in emergency room visit or physician office visit. It was unknown if treatment received for the events. There was no COVID prior vaccination or COVID tested post vaccination. The outcome of events was not resolved.
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| 50 | 2021-03-21 | pain in extremity |
I got my first Pfizer covid shot around 3:30 PM on March 16, 2021. Around 10:00 PM, my arm started ...
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I got my first Pfizer covid shot around 3:30 PM on March 16, 2021. Around 10:00 PM, my arm started to get some soreness. I also noticed that I started feeling really sluggish with some muscle pains. Approximately 11:30 PM, I attempted to go to sleep and noticed that I started having a minor respiratory distress where I could hear myself wheezing. The wheezing only lasted about one hour. All the symptoms disappeared after 36 hours without any treatments or medications. At this point, I'm not sure If I should get my second vaccine shot.
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| 50 | 2021-03-22 | numbness |
Numbness from ring to pinky finger of left arm travelling up to shoulder. Heaviness in lower left ar...
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Numbness from ring to pinky finger of left arm travelling up to shoulder. Heaviness in lower left arm. These symptoms started 1 day after vaccination on 01/15/2021 and have persisted until now. Patient reports worsening symptoms in the last 1-2 days.
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| 50 | 2021-03-23 | feeling hot |
Patient received his first dose of Pfizer COVID-19 vaccine on 3/15/21, administered by store. He had...
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Patient received his first dose of Pfizer COVID-19 vaccine on 3/15/21, administered by store. He had the following reaction within minutes of receiving the vaccine. States he was still under the watch of the clinical team who administered it: Turned red, and got really hot. He tried to stand up, he felt fine but was sweating terribly. He developed a rash on the middle of his back 6-7 inches red rash, it did not itch. Reactions resolved within that same day. However, had a severe headache for about 24 hours.
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| 50 | 2021-03-23 | cold extremities |
Extreme sweating, especially under the armpits. I've never had this before. Both armpits have what l...
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Extreme sweating, especially under the armpits. I've never had this before. Both armpits have what looks like a red skin rash. Also, my toes are extremely cold.
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| 50 | 2021-03-24 | weakness |
Severe sweating; fever; weakness; Worst headache of my life/daily headaches; searing eye pain; fatig...
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Severe sweating; fever; weakness; Worst headache of my life/daily headaches; searing eye pain; fatigue; This is a spontaneous report from a contactable physician (patient). A 50-year-old male patient received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: El1284), via an unspecified route of administration in left arm on 05Jan2021 16:00 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek5730) in the right arm on 16Dec2020 12:00 PM. The patient had no other vaccine in four weeks. The patient had not been diagnosed with COVID prior vaccination. The patient experienced severe sweating, fever, weakness, "worst headache of my life," searing eye pain for the last 2 months, daily headaches and fatigue on 06Jan2021 12:00 AM (also reported as first 48 hours). The events resulted in disability or permanent damage. Treatment was administered for the reported events. Outcome of events was unknown. The patient underwent Covid nasal swab test post vaccination on 27Jan2021 with negative result.; Sender's Comments: Based on temporal association and known drug profile a contributory role of BNT162B2 to the reported events cannot be excluded. Case will be reassessed if additional information is received. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 50 | 2021-03-24 | tingling |
Back of left arm tingled after injection. No shortness of breath /dizziness/lightheadedness A&O Cl...
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Back of left arm tingled after injection. No shortness of breath /dizziness/lightheadedness A&O Client left at 4:45pm arm no longer tingling. No shortness of breath
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| 50 | 2021-03-25 | flushing |
30 minutes after receiving Pfizer COVID vaccine #1 pt reports he became very flushed and hot and fat...
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30 minutes after receiving Pfizer COVID vaccine #1 pt reports he became very flushed and hot and fatigued. Itching started later that night. Face felt swollen but no difficulty breathing, swallowing. I saw him the following day via telehealth and he reported generalized redness was improving but not resolved and pruritis persisted but was improving but the hour.
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| 50 | 2021-03-25 | pain in extremity | Sore arm, body aches, nausea, severe headache |
| 50 | 2021-03-27 | numbness, pain in extremity |
1. Around March 20th, 7 days after the vaccination, felt mild pain between left ear and temple. Pain...
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1. Around March 20th, 7 days after the vaccination, felt mild pain between left ear and temple. Pain was more if the head is shaken or if I jump. This pain disappeared on 27th March. 2. On March 26th both the feet are swollen , left foot more than the right. I still feel slight numbness in the feet today on March 28th. 3. On March 27th , around noon, a blood clott showed up on my left palm , it caused intense pain in the arm for 10 minutes before starting to subside itself. I felt a lump in my palm , it was visible in dark color ,about 1 cm in size. I still feel it in my palm today on 28th March.
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| 50 | 2021-03-27 | tingling | Paresthesia In injection arm and face |
| 50 | 2021-03-27 | tenderness | Swelling in Left Underarm area, slightly painful to touch. Tiredness |
| 50 | 2021-03-28 | bell's palsy |
Part of the face started to clench a little, don't know if that's part of Bell's palsy or that was j...
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Part of the face started to clench a little, don't know if that's part of Bell's palsy or that was just; Heart palpitations; Chills; This is a spontaneous report from a contactable consumer, who reported for himself. A 50-years-old male consumer received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE lot EN6206), via an unspecified route of administration, on 03Mar2021 at 3:15 pm (at the age of 50-years-old) as a single dose for COVID-19 immunization, in left arm. Relevant medical history included cholesterol. Concomitant medications included: Rosuvastatin 20mg, once a day for cholesterol, started a year ago and Vitamin C. On 03Mar2021, the patient had heart palpitations that lasted multiple days. I went to a cardiologist and he wasn't sure whether I should do a second vaccine dose, given that was one of the side effect. He gave me metoprolol which took down the heart rate. But I had the chills, I had part of the face started to clench a little. I don't know if that's part of Bell's palsy or that was just, I just don't know. It wasn't strong, it went away relatively quickly, within 4 hours. Treatment for heart palpitation: Metoprolol Tartrate, 25 mg, one. No treatment received for chills. The clinical outcome of the events Heart palpitations and chills was recovered on 11Mar2021, the outcome of the event face started to clench a little was recovered on 03Mar2021.
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| 50 | 2021-03-28 | pain in extremity, tingling |
Sore arm with tingling down to hand. Very present while running. Tingling not completely gone nearly...
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Sore arm with tingling down to hand. Very present while running. Tingling not completely gone nearly three weeks later.
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| 50 | 2021-03-28 | tingling, numbness, pain in extremity |
one day after: sore arm two days after: numbness and tingling in hand and elbow of left arm (my sh...
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one day after: sore arm two days after: numbness and tingling in hand and elbow of left arm (my shot was in the left upper biceps)
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| 50 | 2021-03-28 | tingling, numbness |
Numbness/tingling in lips then spread to cheek and nose on right side of face. Then right thumb and...
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Numbness/tingling in lips then spread to cheek and nose on right side of face. Then right thumb and index finger and back of right hand numbness and tingling. Has lasted for close to 24 hours.
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| 50 | 2021-03-28 | tingling |
Patient felt pressure in the chest, tingling in the right leg and watery eyes after receiving the va...
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Patient felt pressure in the chest, tingling in the right leg and watery eyes after receiving the vaccine. After drinking water the patient felt better. Heart rate and breathing were fine
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| 50 | 2021-03-29 | feeling hot |
Reported being hot and having a headache. No sign or symptoms of distress. Client monitored then R...
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Reported being hot and having a headache. No sign or symptoms of distress. Client monitored then Released.
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| 50 | 2021-03-29 | flushing | Flushing/sweating, dizziness. BP 106/60 (pulse 63). Final BP 120/82 (pulse 75). |
| 50 | 2021-03-29 | tingling | hands tingling. Evaluated by EMS-Cleared |
| 50 | 2021-03-30 | bell's palsy, facial paralysis |
HISTORY OF PRESENT ILLNESS: HPI Patient is a male presenting to the emergency department with conce...
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HISTORY OF PRESENT ILLNESS: HPI Patient is a male presenting to the emergency department with concerns regarding left-sided facial droop. The patient tells me that he received a COVID-19 vaccine (1st dose) 10 days ago. Patient states that he went to sleep around 23:00 last night. He woke up this morning with left-sided facial droop and inability to close his eye completely on the left. Patient presented to the emergency department for evaluation. He denies any symptoms otherwise. He denies any facial numbness, but states that her rather feels like it is ?paralyzed.? Patient denies any numbness or tingling in his arms or legs. He denies any unilateral arm or leg weakness. He denies any visual changes. No blurry or double vision. He denies any difficulty with speech or finding words. He denies any headache or dizziness. No chest or abdominal pain. No nausea or vomiting. No fevers or chills. No flu-like symptoms. He denies any loss of taste. He denies any numbness or tingling in his tongue or lips. He has no symptoms otherwise. There is no problem list on file for this patient. No past medical history on file. Reviewed and negative. He denies any personal medical history. Denies any family history of strokes or personal history of strokes. Vital signs reviewed. Patient evaluated. Based on exam and history, it is consistent with left-sided Bell's palsy. He has no other neurological symptoms and his neurological exam aside from the facial droop is otherwise unremarkable. I have low concern for stroke based on evaluation today. He has involvement of the forehead muscles. At this point, I did discuss with him that this is Bell's palsy and he will be treated with prednisone and valacyclovir . I do not feel additional workup indicated. He was agreeable. He was given an eye shield that he was given eye lubricant to help avoid dry eye. I did discuss with him that this also may be related to the vaccine given recent administration. I discussed that he should talk to his doctor about this prior to his 2nd dose. Patient instructed to monitor symptoms and all questions were addressed. He was discharged in stable condition Follow-up Information No Results Physician, MD. BLOOD PRESSURE SCREENING: HTN (>/=140/90), recommend follow up with PCP within 1 month. Orders Placed This Encounter Medications ? hypromellose (GENTEAL) 0.3 % GEL ophthalmic gel Sig: Apply 1 Application to left eye if needed for Dry Eyes. Dispense: 10 g Refill: 0 ? valACYclovir (VALTREX) 500 MG tablet Sig: Take 2 tablets by mouth 2 times daily for 7 days. Dispense: 28 tablet Refill: 0 ? predniSONE (DELTASONE) 20 MG tablet Sig: Take 3 tablets by mouth daily for 7 days. Dispense: 21 tablet Refill: 0 ? predniSONE (DELTASONE) tablet 60 mg ? valACYclovir (VALTREX) tablet 1,000 mg
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| 50 | 2021-03-30 | numbness | My right foot is numb. I can move the foot but I don?t have any feeling on the bottom of it. |
| 50 | 2021-03-30 | muscle spasms | Chills, muscle cramping |
| 50 | 2021-03-31 | numbness |
30 minutes after shot administered in left arm, pain in left shoulder blade along with pain on left ...
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30 minutes after shot administered in left arm, pain in left shoulder blade along with pain on left side of neck. After 2 days, pain in neck subsided as pain in left shoulder blade and left shoulder increased and after a week left index finger and thumb became numb. Pain remains in left shoulder, however pain in shoulder blade after 2 weeks moves from left should blade to neck and sometimes both. Loss of sleep due to pain and on a scale of 1-10 pain is an 8-9 constantly. Went to a Chiropractor on Monday, March 29, 2021 for an adjustment and assessment, nerve test reveled nerves in that area not firing properly. Followed with a massage with no avail or reduction in pain or numbness. Have an appointment with DO my doctor on Thursday, April 8, 2021 or if she can get me in sooner.
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| 50 | 2021-03-31 | numbness | NUMBNESS FINGER AND TOES |
| 50 | 2021-03-31 | muscle spasms |
I experienced muscle soreness at the injection site (upper-left arm) around 9P followed by cramping ...
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I experienced muscle soreness at the injection site (upper-left arm) around 9P followed by cramping of my left calf. I went to bed and work up at 2A with body aches, stiffness, and joint throughout my body. The next day I continued experiencing the cramp in my leg and body aches, stiffness, and joint pain throughout my body, and general fatigue. The symptoms were mostly gone after my second night's sleep. I am still feeling lingering (mild) soreness and fatigue today, 4/2/2021.
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| 50 | 2021-03-31 | pain in extremity |
Intense pain in upper arm and shoulder, staying about an hour after injection and laying for approx...
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Intense pain in upper arm and shoulder, staying about an hour after injection and laying for approximately 36 hours. Also fatigue that continues to now.
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| 50 | 2021-03-31 | unresponsive to stimuli |
Responded to Nurse Alert in Covid vaccine clinic Department. Interventions: IV NS 0.9% started ...
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Responded to Nurse Alert in Covid vaccine clinic Department. Interventions: IV NS 0.9% started @ rate: Bolus , time: NA, per instruction (Verbal Order) by Dr. Blood Sugar Reading (per accucheck): 106 mg/dl; Nourishment offered: no Baseline and succeeding Vital Signs: Time Taken 1945 Temperature na Pulse Rate 42 Respiration Rate 16 Blood Pressure 96/62 O2 Saturation 72 Quick Nursing Assessment at the Scene: Pt was dysphoretic, A&Ox3 gray in color. Cold and clammy. Pt reports feeling dizzy and almost falling in the bathroom. During assessment Pt want unresponsive. Pt never lost his pulse. Nurses alert was called than 911. Pt was A&Ox3 when EMS arrived. 2L of O2 NC was placed on Pt and SPO2 increased to 100%. 20G IV was started in the left AC and NS bolus was rendered. EMS ALS took Pt to the nearest hospital. Pt did receive 0.3 second dose of Pfizer vaccine. Patient Disposition: 911 called.
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| 50 | 2021-04-01 | tingling |
Starting 3/30/21 head and whole body paresthesias with mild chest tightness. Still present 4/2/21 a...
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Starting 3/30/21 head and whole body paresthesias with mild chest tightness. Still present 4/2/21 and symptoms about the same. No weakness, change in mental status, shortness of breath or loss of any function.
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| 50 | 2021-04-02 | feeling cold |
Major (extreme) chills (almost uncontrollable chills and coldness, teeth rattling, slight delirium);...
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Major (extreme) chills (almost uncontrollable chills and coldness, teeth rattling, slight delirium); body aches, major headache. Couldn't get warm despite spouse providing me with multiple blankets that night. Took tylenol to help with headache through the night. Woke up the next day with major body aches throughout my body. Continued headache and fatigue like symptoms along with the pain. Used tylenol PM the second night to combat continued headache but no chills the second night. Started to feel better today, April 3rd, which is 48 hours since my 2nd Pfizer vaccination.
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| 50 | 2021-04-02 | pain in extremity |
Sore arm for a day after; This is a spontaneous report from a Contactable Consumer (patient's wife)....
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Sore arm for a day after; This is a spontaneous report from a Contactable Consumer (patient's wife). A 50-year-old male patient received first dose of bnt162b2 (BNT162B2; Solution for injection) via unspecified route of administration on 27Jan2021 at single dose for covid-19 immunization. Her husband takes no medications. He has no medical history or conditions. He has no allergies at all. It was reported that She thought she would report some side effects after one shot of the Pfizer COVID19 Vaccine. It is strange. She didn't read the symptoms until seven days out. Then she saw some have reported a lot less. After the shot, that night she had swelling in her upper chest. She thinks it was lymph nodes in the breast and chest area on the side she got the shot. The next day her arm that she got the vaccine in got very large. Then, she doesn't know if it was related, two days later she had itching on both of her feet. It was the tops of her feet and only for a couple of days. She is not counting that. Day five after the shot has been the main problem. Her arm pits started itching like crazy. It was severe itching and swelling in her arm pits. The itching lasted for three to four days. The lymph nodes in her arm are still swollen. It was five days after the shot. It is both arm pits. The night of the shot she had a lot of neck pain and she thinks it was probably the lymph nodes in the back of her neck. That has lasted and is slowly diminishing. Height six-foot one inch or six foot two inches. Weight 225 to 230 pounds. He is not obese, but a big guy. There was an agency for assisted living for people that need help. They were giving it and had extra doses. This guy in charge at the assisted living house offered it to caller and caller's husband because her and her husband run a behavior health counseling. He offered it to them as healthcare professionals. Her husband got it at the same time and didn't even have a sore arm. Caller clarified that he did have a sore arm for a day after. It didn't swell up. The outcome of the event was "Unknown". Information on the lot/ batch number has been requested.
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| 50 | 2021-04-02 | tremor | Headaches Bodyaches Vomiting Fever Shakiness Heart racing |
| 50 | 2021-04-04 | pain in extremity |
Two days after receiving vaccine, left side neck, left arm, and back began to hurt as if a nerve was...
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Two days after receiving vaccine, left side neck, left arm, and back began to hurt as if a nerve was pinched. It is still happening.
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| 50 | 2021-04-05 | hot flush, numbness |
4-Apr, 20:00 - pain at injection site, numbness in right ring and pinkie fingers. Numbness cleared ...
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4-Apr, 20:00 - pain at injection site, numbness in right ring and pinkie fingers. Numbness cleared after vigorous flexing of hand. Repeated symptom and solution throughout night. Treatment: see above 5-Apr, 02:30 - pronounced pain at injection site and right hip (site of existing injury) radiating to groin, nausea (without vomiting), alternating hot flashes and chills, generalized muscular discomfort. Treatment: OTC painkiller (Tylenol) 5-Apr, 04:00 - Headache, sound of rushing blood in right ear. Treatment: none
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| 50 | 2021-04-06 | flushing |
Flushing, headache, and hypertension Treated with intravenous ketorolac and famotidine Flushing, hea...
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Flushing, headache, and hypertension Treated with intravenous ketorolac and famotidine Flushing, headache, and hypertension improving
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| 50 | 2021-04-07 | feeling cold |
Fever and chills beginning approximately 14 hours after second shot. Insomnia and racing heart all ...
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Fever and chills beginning approximately 14 hours after second shot. Insomnia and racing heart all night. Body felt extremely cold, and I had to add three layers of sweatpants/sweatshirts/socks to stay warm. Headache and fatigue lasted approximately 48 hours. Took 72 hours to feel back to 100%
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| 50 | 2021-04-07 | pain in extremity, night sweats |
First dose, next morning. Slight body aches low fever (below 100), lethargy and foggy headedness. ...
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First dose, next morning. Slight body aches low fever (below 100), lethargy and foggy headedness. Arm hurt at injection site and pain spread slightly. All symptoms seemed worse day 2 post shot (3/17/2021). Persisted for about 4 days, gradually getting better. Went to work but was pretty miserable. Took Tylenol and Ibuprofin alternating every 2 hours for fever. Second dose next morning. Higher fever (topped at about 101 and change), severe fatigue, slept 18 hrs and took off work. Alternated tylenol and ibuprofin every 2 hours. Also chills, heavy night sweat body aches.. Next day, sub 100 fever that "rollercoastered" all day. Alternated tylenol and ibuprofin every 2 hours. Body aches, arm ached at injection site. Worked from home. Day 3 post injection (4/8/21) felt better, went to work, fine in the am, slight fatigue towards shift's end.
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| 50 | 2021-04-07 | pain in extremity |
In evening severe left arm and neck soreness, very tired, followed by prolonged diarrhea which cont...
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In evening severe left arm and neck soreness, very tired, followed by prolonged diarrhea which continued until next day.
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| 50 | 2021-04-08 | facial paralysis, bell's palsy |
Two to three hours after injected, I bit my inner lip several time while eating. My wife said left...
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Two to three hours after injected, I bit my inner lip several time while eating. My wife said left side of face seem swelling. The next morning has symptoms of Bell's Palsy. Left side of face seem paralysis. As days progress, the symptoms was more obvious. Text doctor on Sunday and Doctor office called on Monday and recommend i go to ER to confirm .
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| 50 | 2021-04-08 | pain in extremity |
Pain in right big toe. Pain got worse throughout the night, pain on touch and in joint of toe. Una...
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Pain in right big toe. Pain got worse throughout the night, pain on touch and in joint of toe. Unable to put pressure on it, unable to sleep. Pain subsided~12 hours after start. After 24 hrs no pain at all. No other adverse effects.
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| 50 | 2021-04-08 | tremor, tingling |
Site: Swelling at Injection Site-Mild, Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mi...
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Site: Swelling at Injection Site-Mild, Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Nausea-Mild, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: patient described as an almost panic attatck reaction - shakiness, dizziness, blurry vision, nausea. Blood pressure and heart rate not elevated. SAt for 20 minutes and started feeling better then got the chills and more shakiness
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| 50 | 2021-04-09 | flushing |
Face Flushing. About 2 hours later face became red but no other symptoms and patient was counseled t...
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Face Flushing. About 2 hours later face became red but no other symptoms and patient was counseled to go to ER if any other symptoms develop.
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| 50 | 2021-04-09 | hot flush |
I am dizzy and can't hardly stand up, having severe hot flashes, throwing up, gagging, fatigue , out...
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I am dizzy and can't hardly stand up, having severe hot flashes, throwing up, gagging, fatigue , out of it and dry mouth. I need help. The room keeps spinning!
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| 50 | 2021-04-09 | hot flush |
fatigue; chills; hot flashes; headache; insomnia; This is a spontaneous report from a contactable 50...
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fatigue; chills; hot flashes; headache; insomnia; This is a spontaneous report from a contactable 50-year-old male consumer reported that a 50-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Age at vaccination: 50 Years), dose 2 via an unspecified route of administration, administered in Arm Right on 11Feb2021 13:00 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included hypertension. Concomitant medications included amlodipine besilate (NORVASC); telmisartan (MICARDIS); zinc; VITAMIN C [ASCORBIC ACID]; vitamin d nos. The patient previously received first single dose of bnt162b2 on Right arm on 21Jan2021,11:00 single (Age at vaccination: 50 Years) for Covid-19 immunization. the patient not receive any other vaccines within 4 weeks prior to the COVID vaccine; List of any other medications the patient received within 2 weeks of vaccination: Norvasc, Micardis, multivitamin, vitamin C+D+zinc. On 11Feb2021 21:15, patient had fatigue, chills, hot flashes, headache, insomnia. Patient received treatment with Advil. Prior to vaccination, the patient not diagnosed with COVID-19. Since the vaccination, the patient not been tested for COVID-19. The outcome of the events was recovering. Information on the lot/batch number has been requested.
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| 50 | 2021-04-10 | bell's palsy | Pfizer-BioNTech COVID-19 Vaccine EUA Diagnosed with Bell?s palsy. |
| 50 | 2021-04-10 | tenderness |
Vaccine administered 9.20am. Fatigue shortly after vaccine was administered - slept most of afternoo...
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Vaccine administered 9.20am. Fatigue shortly after vaccine was administered - slept most of afternoon. Injection site pain - feels like been punched in arm. Headache in the evening. Night chills and complained of "tight" (not acute) chest pain... but no breathing problems. Morning fever of 101F. Headache, Dizzy, Fatigue, Muscle Pain (esp in legs, asif he had "run a marathon"). He spent most of the day "resting". Evening on day two, we noticed a large bump under his vaccinated arm. Radius about 5cm - larger than what I know swollen lymph nodes to look like - almost looks like a bicep between his armpit and nipple. Tender to touch. Morning of day three (48 hours after vaccine) bump under his arm remains and all other symptoms seem milder.
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| 50 | 2021-04-11 | weakness |
After dose 1 on 3/18/21, extreme fatigue for two weeks and arm hurt for a couple days at shot site....
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After dose 1 on 3/18/21, extreme fatigue for two weeks and arm hurt for a couple days at shot site. After dose 2 on 4/8/21, weak, chills and body aches all over for one day on 4/9, and arm hurt for a couple days at shot site.
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| 50 | 2021-04-11 | numbness |
3 days after shot I developed a rash on my neck, torso ,arms and hands. My thumbs where swollen and ...
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3 days after shot I developed a rash on my neck, torso ,arms and hands. My thumbs where swollen and numb. I developed a fever ranging from 101 to 104.4 for 48 hours. intense body achs.
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| 50 | 2021-04-11 | nerve pain |
Approximately 36 hrs after the injection I started feeling severe nerve and muscle pain to the left ...
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Approximately 36 hrs after the injection I started feeling severe nerve and muscle pain to the left deltoid (the injection site). there are no other signs or symptoms noted. It is a debilitating pain especially after even the most mundane of tasks. OTC pain relief is ineffective.
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| 50 | 2021-04-12 | weakness |
Weakness, headache, nausea, exhausted, wanting to sleep constantly, trouble breathing when sleeping(...
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Weakness, headache, nausea, exhausted, wanting to sleep constantly, trouble breathing when sleeping(wife noticed this). These symptoms although getting better have lasted six days.
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| 50 | 2021-04-12 | difficulty speaking |
About 6.5 hours after vaccination my throat got a bit dry and feeling like a start of a cold /raspy ...
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About 6.5 hours after vaccination my throat got a bit dry and feeling like a start of a cold /raspy feeling and I felt two spots on the front of my neck itching. I looked in mirror and saw two pimple size type spots itchy. over the neck 30 mins another itchy pimple grew and neck got a bit red and under an ear got red and itchy. over the next hour my breathing felt a little more difficult, though oxygen level oximeter reading still good. 8.5 hours after vaccination both sides of my upper back/shoulders were covered in hives. I felt a bit foggy also. I administered epinephrine pen to my thigh. Over next few minutes the hives disappeared (except for a few pimple size spots though they basically disappeared)and the itch was gone. My breathing felt fine. I monitored signs and symptoms with no noticeable issues for the next day+. This was the 1st time I ever used an epi pen.
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| 50 | 2021-04-12 | numbness, tingling |
20 - 25 Mins after shot, Left side of face from ear down to jaw and chin started to go numb and ting...
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20 - 25 Mins after shot, Left side of face from ear down to jaw and chin started to go numb and tingly. tingling continued down on left side of neck from ear to adams apple. Felt consistent with novocaine wearing off and my ear/jaw was numb. Went to ER @ the Hospital, I had an EKG done and they checked physically for stroke. I was in Hospital for approx. 1.25 hours and the feeling started to go away.
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| 50 | 2021-04-12 | tremor, flushing |
Roughly 30 mins (10:30am) after I received my 2nd Pfizer vaccine shot, I was about 5 mins from my ho...
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Roughly 30 mins (10:30am) after I received my 2nd Pfizer vaccine shot, I was about 5 mins from my home and began to feel tingling/numbing in my mouth and tongue. I got in my house and told my wife I was not feeling right and started to notice a dizziness coming on. I was to call the pharmacy to find out what I should do, but noticed my heart rate was up, I looked at my Apple watch monitor and my BPM was 164. I felt flush and told my wife to call 911. Ambulance arrived and took my vitals and ( I do not recall the blood pressure, but it was high for me) when they put me into the ambulance I began to shake uncontrollably and then began to sweat profusely. They took me to the emergency room, but did not administer any drugs. The Dr. came in and said he did not think it was related to the vaccine, but my personal Dr. agreed with me based on my medical history that it had to be related to the vaccine. My resting heart rate (I monitor this daily) is between 45 - 60 and my last blood pressure reading at my yearly physical on April 2nd, 2021 was 100/70.
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| 50 | 2021-04-13 | pain in extremity |
He began to develop a rash on his left arm about three hours after having the vaccine. At first ther...
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He began to develop a rash on his left arm about three hours after having the vaccine. At first there were lumps, then the appearance of blisters, draining clear liquid eventually. The rash continues to itch. His left arm hurts. At the time of evaluation 4/13/2021, the lumps were discrete, some excoriated, scabbing, not in a linear pattern, located on his left upper arm and lower arm.
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| 50 | 2021-04-14 | flushing |
Approx. 30 min after receiving 2nd dose of COVID vaccine pt stated feeling "dizzy and flushed." Pt t...
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Approx. 30 min after receiving 2nd dose of COVID vaccine pt stated feeling "dizzy and flushed." Pt taken by wheelchair to private observation area and VS assessed by RN. Pt noted to have an elevated BP outside of normal parameters. Pt aox4, denies any pain, sob, chest pain or difficulty breathing. Pt continued to monitored and assessed by RN over a period of approx. 30 min. and BP remained elevated outside normal parameters. Pt agreeable to be treated in Emergency Room. Pt taken by wheelchair to ED by charge nurse and another ED staff member. Pt able to follow commands and able to ambulate on his own to wheelchair. Pt denies any dizziness, blurred vision, nausea, sob, head/chest pain or difficulty breathing.
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| 50 | 2021-04-15 | muscle spasms |
Severe allergic reaction anaphylactic shock Hives, rash,swelling, headache, stomach ache, body aches...
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Severe allergic reaction anaphylactic shock Hives, rash,swelling, headache, stomach ache, body aches, elevated heart rate, uncontrollable body spasms, loss of appetite
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| 50 | 2021-04-16 | muscle spasms, muscle twitching |
Had soreness and tenderness at injection within one hour of vaccination. Approximately 13-15 hours a...
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Had soreness and tenderness at injection within one hour of vaccination. Approximately 13-15 hours after Vaccination, woke from sleep with fever and chills. Fever was 100 as measured using oral digital thermometer. Experienced mild body muscle aches and stiffness, especially in the upper back, shoulders and neck. Had mild to moderate fatigue and persistent headache at base of skull. Also experienced muscle twitching within 2 hours of vaccination through the lower limbs and torso, with more activity concentrated in the legs and feet. Was not painful, but strange. Some of this muscle fluttering and twitching preceded muscle cramping in the feet. Frequency was almost continuous with short, 60 second pauses between twitches. The moved and we?re not in the same exact location. We?re especially active when when lying flat, relaxed in bed. All symptoms aside from the twitching subsided fully by the following Morning (April 15th 2021). Took body temp that morning and had returned to 98.7 f. Muscle twitches have continued five days beyond vaccination, although they have grown milder and less frequent.
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| 50 | 2021-04-16 | night sweats |
Shot was received at 6:15pm and symptoms started at 7:30am. I had a soar arm at injection site. Se...
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Shot was received at 6:15pm and symptoms started at 7:30am. I had a soar arm at injection site. Severe dizziness to the point I could not walk, headache and joints pains started around 10am while at work. I left work at 1:30pm When I got home around 2:00pm, I felt tremendous amount of fatigue. I slept from 2pm until 5:00pm. I went back to bed at 6:30pm. During the night I had cold chills and sweated all night until my sheets were drenched. I slept until 9:30am. I felt much better after taking a shower. I would not have the second dose!!
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| 50 | 2021-04-17 | bell's palsy |
patient developed Bell's palsy, left sided facial nerve palsy 2 days after getting first Pfizer vacc...
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patient developed Bell's palsy, left sided facial nerve palsy 2 days after getting first Pfizer vaccine. he is being treated with oral prednisone/Valtrex for bell's palsy now. no fevers or bodyaches. mild left deltoid soreness after injection.
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| 50 | 2021-04-18 | weakness |
Shortness of Breath with cough , generalized weakness, left rib pain radiating to upper back pain (s...
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Shortness of Breath with cough , generalized weakness, left rib pain radiating to upper back pain (sharp in nature)
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| 50 | 2021-04-18 | numbness, facial paralysis |
I have facial numbness on left side of my face. I cannot move my left eye freely, and left side of ...
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I have facial numbness on left side of my face. I cannot move my left eye freely, and left side of my lips freely. I cannot close or open my left eye, and left side of my lips are droopy.
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| 50 | 2021-04-19 | tenderness |
Given at . Patient presents to office 4/20/2021. Rash which is similar to others noted in A reacti...
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Given at . Patient presents to office 4/20/2021. Rash which is similar to others noted in A reactivation of shingles over the upper chest arm and back. Started five days after vaccine, with five small patches of raise clusters of small blisters. Has spread to neck , top of shoulder and back. Symptoms include pain to touch and itching.
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| 50 | 2021-04-20 | slurring |
Pt felt "strange and uneasy" right after the vaccine. Sunday (3 days post shot) pt had very dry mo...
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Pt felt "strange and uneasy" right after the vaccine. Sunday (3 days post shot) pt had very dry mouth, numb tongue, and sore inside his mouth. Patient's wife reports slurred speech. Symptoms have been slowly getting worse since Sunday.
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| 50 | 2021-04-20 | tingling, numbness, feeling cold | left hand numb, left arm cold sensation and tingling, resolved, pt. left site. |
| 50 | 2021-04-21 | numbness, discomfort |
Consistent numbing discomfort that develops into pain daily. Affected area is from the elbow to the...
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Consistent numbing discomfort that develops into pain daily. Affected area is from the elbow to the shoulder. Feels as if there is inflammation in the center area of the arm. Responds to ibuprofen or rest/sleep bur reoccurs in the same cycle daily.
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| 50 | 2021-04-22 | weakness | 4 hours shivering, joint and muscle pain, 24 hours weakness |
| 50 | 2021-04-22 | numbness |
Shortness of breath, heart palpitations, vertigo/dizziness, phantom body pains appearing and disappe...
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Shortness of breath, heart palpitations, vertigo/dizziness, phantom body pains appearing and disappearing in various places, occasional itching sensation, numbness, brain fog, double-vision, extreme tiredness. Symptoms tapered off over 3-5 days. Similar experience with 2nd vaccine but less pronounced with a shorter timeframe, tapering off after 2-3 days. Strongest side effects after first vaccine, symptoms did not become noticeable until a couple of hours after it was administered, increasing next 24 hours before lessening over time. Basically identical to long covid symptoms but lasting only for a few days after vaccinations and not before.
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| 50 | 2021-04-22 | nerve pain, burning sensation |
Headache 2-3 days; Day 3 the rash began on both legs with blisters, itching, pain, burning sensation...
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Headache 2-3 days; Day 3 the rash began on both legs with blisters, itching, pain, burning sensation appeared to be shingles (I have had shingles previously but no shingles vaccine) Lasted a total of 2.5 weeks until most symptoms were gone. Still have occasional nerve pain and burning.
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| 50 | 2021-04-22 | pain in extremity |
Patient is here with complaints of left calf pain. Started after returning from city on 4/12. Drove ...
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Patient is here with complaints of left calf pain. Started after returning from city on 4/12. Drove home. Was very sore, treated with aspirin. Helped at first but now pain and swelling have persisted. Did go jogging while on vacation and thought this may have attributed, now more concerned about DVT. Brother with history of blood clots but is a smoker.
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| 50 | 2021-04-23 | weakness |
2 weeks from the day I received the shot I developed a half dollar sized round rash on the opposite ...
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2 weeks from the day I received the shot I developed a half dollar sized round rash on the opposite arm that the shot was administered. The rash was red in color, raised skin and was located near my right bicep, inside elbow area. This rash subsided for most part the day after. Also had the chills for over 48 hours, slight headaches on and off and was extremely tired with low energy. It felt like I was in a fog for a couple of days.
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| 50 | 2021-04-23 | flushing, unresponsive to stimuli |
Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unrespo...
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Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Severe, Additional Details: anxious before the shot. started sweating and felt dizzy 2-3 minutes after the shot. gave water to patient and asked them to take deep breaths. patient then started to become unresponsive,pale with no blood flow to face. no improvement was seen and then epinephrine shot (adult) was administered. patient started to regain consciousness and became slightly responsive after a couple minutes. had the patient sit down and put theit legs up on a chair. EMT arrived and out of caution took them to ER.
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| 50 | 2021-04-24 | weakness | Flu like , muscle ackes everywhere, no energy, and no hunger only for one day. |
| 50 | 2021-04-24 | bell's palsy |
Bell's Palsy that affects the right side of his face; This is a spontaneous report from a contactabl...
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Bell's Palsy that affects the right side of his face; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP6955), via an unspecified route of administration on 28Mar2021 at 16:45 (at the age of 50 years) at a single dose in the right arm for COVID-19 immunization. Medical history included overweight and high blood pressure. The patient's concomitant medication included an unspecified multivitamins. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 29Mar2021 at 17:00, the patient was diagnosed with a case of Bell's Palsy that affects the right side of his face. The event resulted in emergency room/department or urgent care. Prescription medications were given as treatment for the event. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was not recovered.
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| 50 | 2021-04-24 | pain in extremity |
headache; unable to maintain an erection/ some issues with maintaining an erection; soreness in his ...
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headache; unable to maintain an erection/ some issues with maintaining an erection; soreness in his arms/ soreness was on both shoulders; real soreness" in his arm where he got the injection/ injection site had pain; developed a "large lymph node under that arm", which he "feels internally"/ lymph node he could feel internally/ internal bone like pain; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration on 31Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE at the arm right (reported as right shoulder) for covid-19 immunisation (reported as he is trying to avoid serious illness). The patient medical history includes sleep from unknown date and if ongoing. Concomitant medication included zolpidem (reported as generic ambien) taken for sleep, start and stop date were not reported and added that he has been taking it for years but he hasn't taking it since he got the vaccine but thinks he took it the day before. The patient previously took bnt162b2 first dose on 10Mar2021 (roughly two weeks before the second dose) at the left shoulder for covid-19 immunisation. It was reported that the patient had no reaction to the first dose of the Pfizer-BioNTech COVID-19 vaccine, and he received the second dose on 31Mar2021. He explained following the second dose, his first issue was a "headache", then he had "real soreness" in his arm where he got the injection. He added he developed a "large lymph node under that arm", which he "feels internally". He specified he still feels it a week later. He also explained he is "unable to maintain an erection". He described himself as "athletic" and specified not having erectile problem in the past. He asked if his current symptoms have been reported as side effect to the vaccine. It was also added that after the second dose he appeared to have some issues with maintaining an erection on 04Apr2021. It was stated he is fairly active with a muscular build and could be a result after an exercise injury but this did happen after his second shot. Caller states he also had soreness in his arms and an enlarged lymph node under his arm that he could feel with his hand but that went away yesterday (from 01Apr2021 to 07Apr20210). The soreness was on both shoulders but he thinks the soreness on the other shoulder is from lifting weights and the shoulder from the injection site had pain, internal bone like pain (from 01Apr2021 to 07Apr20210). It was stated that the lymph node he could feel internally but didn't protrude through skin and went away yesterday and lasted 6-7 days. It was also reported that the soreness and lymph node went away yesterday and believes everything will get back to normal, he expected soreness to last a couple of days and it lasted a week. The patient stated he took some sleep medication after the second injection. He doesn't remember if it was the night before the injection. He took Ambien, a higher dosage. States maybe issues with maintaining an erection are beginning to improve. It was also stated the soreness and lymph node he noticed it the day after the injection, by the evening of 01Apr2021 and as of yesterday 07Apr2021 evening it feels like its completely back to normal. It was noted for the treatment that he didn't take anything but bought a gripper where he squeezes it and builds strength in his hands to give him some relief. The patient added that he's pretty active, he works out 4-5 days a week, including running. The outcome of the event some issues with maintaining an erection/ unable to maintain an erection was recovering; for the event headache was unknown, for all other events was recovered on 07Apr2021. Information about the Lot/batch number has been requested.
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| 50 | 2021-04-24 | seizure |
Generalized seizures without ever having a seizure before; This is a spontaneous report from a conta...
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Generalized seizures without ever having a seizure before; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date not available), via an unspecified route of administration, Left arm on 08Apr2021 at 09:00 AM (at the age of 50-years-old) at a single dose for COVID-19 immunization. The patient's medical history was reported as none. The patient had no known allergies. Concomitant medication included celecoxib (CELEXA). The patient was vaccinated at a hospital. No other vaccine was given in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced generalized seizures without ever having a seizure before on 10Apr2021 at 15:00. The event caused hospitalization in Apr2021 and was also reported as life-threatening. The patient underwent lab tests and procedures which included nasal swab test: negative on 10Apr2021. Therapeutic measures taken as a result of the event included hospitalization and med flight, as reported. The outcome of the event was not recovered. Information about lot/batch number has been requested.
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| 50 | 2021-04-26 | discomfort, muscle spasms, weakness |
42-43 hours after receiving the first dose of the Pfizer vaccine, patient starting projectile vomit...
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42-43 hours after receiving the first dose of the Pfizer vaccine, patient starting projectile vomiting, approx. or 10 times, every hour from 10am Sunday, 4/25 until approx. 2pm 4/25. Patient also had extreme abdominal pain (score of 10 on a 10 point scale) , showed signs of extreme agitation, discomfort , weakness, mild disorientation. no fever at this time nor diarrhea . Due to extreme abdominal pain and vomiting, patient was taken to Emergency Room where he was given medications to stop the vomiting, cramping . Tests run: EKG, CAT scan and blood work. Blood was normal, and EKG. CAT scan showed extreme swelling and inflammation to the entire abdominal cavity. Patient was discharged after pain was brought under control . Within hours of coming home the patient started to experience sever diarrhea, (watery discharge every hour for about 6 hours - patient estimates at least a gallon or more of liquid loss). Patient was on Gatorade, water intake , as much as he could take , continuously. No vomiting was experienced, but at this point patient was on the medications to control symptoms given at ER discharge. Patient experienced intermittent sharp pain despite medications to stop cramping and coat stomach and nausea continued despite nausea medication . on Monday, April 26th, around 3pm the abdominal pain increased, and by 10pm a high fever was present: 102.8 without ibuprofen, 101.4 with ibuprofen, and at this writing, Tue 4/27/21 at 2:30pm, the fever continues at 101.4 with continuous ibuprofen. The patient has not eaten solid foods and is now on Pedialyte, He has vomitted twice since 7am and is currently experiencing diarrhea .
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| 50 | 2021-04-26 | pain in extremity |
Pain on left arm for 1 day, Headaches 6 days, bodyache 6 days ,chills ,soft stool for 2 days and Ti...
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Pain on left arm for 1 day, Headaches 6 days, bodyache 6 days ,chills ,soft stool for 2 days and Tiredness 6 days.
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| 50 | 2021-04-26 | pain in extremity |
Lower back pain (continuous as of today however less than before), fatigue (7 days), mid-chest pain ...
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Lower back pain (continuous as of today however less than before), fatigue (7 days), mid-chest pain (1.5 days), intermittent dull pulse pain?right leg calf (continuous)
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| 50 | 2021-04-27 | facial paralysis |
Patient presented to the emergency room with right sided facial droop including foreheady, +bells si...
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Patient presented to the emergency room with right sided facial droop including foreheady, +bells sign, no sensation deficits, no other focal numbness or weakness. Patient also reports dry eye which cannot close. In rhe ER he received 60mg prednisone and, 1000mg valtrex. He received prescription for prednisone (60mg/day for 5 days), valtrex (3 grams/day for 7 days) and hypromellose artifical tear drops). He as instructed to with PCP and neurology.
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| 50 | 2021-04-27 | muscle spasms, cold extremities |
Awoke to uncontrollable spasmatic shivering, ice cold feet, increased heart rate of 110, increased b...
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Awoke to uncontrollable spasmatic shivering, ice cold feet, increased heart rate of 110, increased blood pressure 151/84. Worst of it lasting over 1 and a half hours before extreme shivering subsided with continued stress.
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| 50 | 2021-04-28 | flushing, weakness |
Systemic: Dizziness/Lightheadedness-Mild, Systemic: Flushed/Sweating-Mild, Systemic: Visual Changes/...
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Systemic: Dizziness/Lightheadedness-Mild, Systemic: Flushed/Sweating-Mild, Systemic: Visual Changes/Disturbances-Mild, Systemic: Weakness-Mild, Additional Details: Patient reported feeling dizzy and was found on floor after the vaccine. He was asked to wait for about 30 minutes for extra monitoring. Called patient after he arrived home and reported feeling okay.
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| 50 | 2021-04-28 | tremor, flushing |
During 15 minute observation period, patient complained of dizziness, lightheadedness and minor stom...
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During 15 minute observation period, patient complained of dizziness, lightheadedness and minor stomach upset. Patient was instructed to sit down, his feet were elevated, a cold compress was applied. Patient's blood pressure, heart rate and pulse ox were taken. First blood pressure reading was 168/54 mmHg, first pulse was 71 bpm and pulse ox was 98-99%. Patient was shaky, anxious, and flushed. No complaints of shortness of breath, itching, or swelling of the face/mouth. Repeat vitals after 10 minutes were 185/105 mmHg, pulse was 76 bpm, and pulse ox was 100%. Patient was still dizzy and shaky. Administered 50 mg of diphenhydramine orally and contacted transport to emergency room. While waiting for transport, patient complained of forehead and forearm itching. Still no complaints of shortness of breath, no coughing or lip swelling. Noted red hives starting to appear. EMT arrived and took over care.
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| 50 | 2021-04-29 | pain in extremity | Pain in arm muscles pain drowsy headache |
| 50 | 2021-04-30 | weakness |
Severe 'chicken-pox' like rash began on arms; face pustules; eruct; infection; scarring result; Low ...
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Severe 'chicken-pox' like rash began on arms; face pustules; eruct; infection; scarring result; Low energy; digestive symptoms; skin problems; This is a spontaneous report from a contactable consumer (patient himself). A 50-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in the right arm on 05Feb2021 at 12:00 (Batch/Lot Number: EL3249) as a single dose for COVID-19 immunization. The vaccination facility type was reported as the hospital. Relevant medical history included asthma and known allergies to sulfur and intravenous (IV) contrast; all from an unknown date and unknown if ongoing. Concomitant medications included lisinopril; atenolol; and omeprazole (PROTONIX); all taken for an unspecified indication, start and stop date were not reported. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 21Jan2021 at 12:00 PM (lot number: EK9231) at the age of 49 years, administered on the right arm for COVID-19 immunization. The patient had no other vaccine in four weeks. The patient had no prior vaccination. On an unspecified date in Mar2021 at 12:00 PM, the patient experienced severe 'chicken-pox' like rash began on arms; face pustules, eruct, infection; scarring result; low energy; and digestive symptoms in correlation with skin problems. All the adverse events (AE) resulted in a doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care; and had also led to disability or permanent damage. The patient underwent lab tests and procedures, which included COVID-19 test via nasal swab: inconclusive on 20Mar2021 (post vaccination). Therapeutic measures were taken as a result of all the events, which included topical corticosteroids, oral steroids, and oral antibiotic (antib). The patient was not recovered from all the events.
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| 50 | 2021-04-30 | pain in extremity |
Fatigue/tiredness; cough; head cold; congestion; arm pain; This is a spontaneous report from a conta...
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Fatigue/tiredness; cough; head cold; congestion; arm pain; This is a spontaneous report from a contactable consumer reported for himself. A 50-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in arm right on 01Apr2021 11:45 as single dose for COVID-19 immunisation. Medical history included diabetes mellitus. No known allergies. Concomitant medications included metformin 500 mg, amlodipine besilate (NORVASC) 2.5 mg. The patient experienced fatigue, cough, head cold, congestion, tiredness, arm pain on 08Apr2021 (also reported that on the 4Apr2021 was when the symptoms started), that lasted 24 hours, no treatment received for the adverse events. The events were reported as non-serious. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was recovering. The patient became aware that it may have to do with the vaccine and not with his seasonal allergies on the 11Apr2021. No follow-up attempts are needed. No further information is expected.
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| 50 | 2021-05-09 | seizure | CEREBROVASCULAR ACCIDENT R56.9 - Seizure (CMS/HCC) |
| 50 | 2021-05-11 | seizure |
Brain inflammation; Stroke like event/seizure; Stroke like event/seizure; This is a spontaneous repo...
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Brain inflammation; Stroke like event/seizure; Stroke like event/seizure; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine), via an unspecified route of administration, administered in left arm on 19Apr2021 16:00 (Lot Number: ER8731) 2ND DOSE, single for COVID-19 immunization. Medical history included rheumatoid arthritis from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received 1st dose of bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine, lot number: EP6955) on 29Mar2021 01:00 PM in the left arm for COVID-19 immunization and experienced stroke like event/seizure. The patient had stroke like event/seizure following first and second injections. The patient also had brain inflammation. Events onset date reported as 22Apr2021 11:00. The events were reported as serious due to hospitalization in Apr2021 for 5 days. Events resulted in doctor or other healthcare professional office/clinic visit and a visit to emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient been tested for COVID-19 since the vaccination. Outcome of events was unknown. The patient underwent lab tests and procedures which included Nasal Swab: negative on 22Apr2021. No treatment received for the events. Further information has been requested.
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| 50 | 2021-05-12 | seizure |
seizure; Stroke like event; This is a spontaneous report received from a contactable consumer (Patie...
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seizure; Stroke like event; This is a spontaneous report received from a contactable consumer (Patient) reporting for himself. A 50-year-old male patient received first dose of BNT162B2 (BNT162B2) via an unspecified route of administration on 29Mar2021 01:00 (Batch/Lot Number: EP6955) as SINGLE DOSE for covid-19 immunization. Medical history included rheumatoid arthritis from an unknown date. The patient's concomitant medications were not reported. The patient experienced seizure and stroke like event on 22Apr2021 at 11:00. The patient was hospitalized for seizure and stroke like event for 5 days. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 22Apr2021. Outcome of the events was unknown Information on Lot/Batch number was available. Additional information has been requested.
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| 50 | 2021-05-18 | bell's palsy |
Bell's Palsy - Left Side of Face; This is a spontaneous report from a contactable consumer (patient)...
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Bell's Palsy - Left Side of Face; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 28Apr2021 (Batch/Lot Number: EW0171) as 2nd dose, single for covid-19 immunisation. The first dose was received on 03Apr2021 (lot number: ER8733). There were no medical history. Concomitant medications included metformin, diazepam and lisinopril. No other vaccine were received within 4 weeks. The patient experienced bell's palsy - left side of face on 03May2021 10:00. Event resulted in physician's clinic visit. Outcome of the event was not recovered. Patient was not diagnosed with covid-19 prior to vaccination and had not been tested post vaccination.
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| 50 | 2021-05-19 | bell's palsy | Bell's palsy affecting left facial nerve |
| 50 | 2021-05-21 | speech disorder |
nurse stated it could possibly be blood clots; Patient is afraid he is going to have a stroke or sca...
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nurse stated it could possibly be blood clots; Patient is afraid he is going to have a stroke or scared he had one after the COVID-19 Vaccines; blurred vision in right eye that comes and goes; ringing in his left ear; Very fatigued throughout the day, sleeping a lot/tired and sleeps a lot; Very fatigued throughout the day, sleeping a lot/tired and sleeps a lot; Date received First dose: Third Friday in Feb2021/Received second dose on 12Apr2021, six weeks after first dose; Date received First dose: Third Friday in Feb2021/Received second dose on 12Apr2021, six weeks after first dose; Fullness in face; Body aches; Brain fog: At times he can't do the simplest things. He will look at the clock on the wall and says he knows what it is, but can't find the words to say. Cannot carry on a conversation intelligently; Brain fog: At times he can't do the simplest things. He will look at the clock on the wall and says he knows what it is, but can't find the words to say. Cannot carry on a conversation intelligently; Brain fog: At times he can't do the simplest things. He will look at the clock on the wall and says he knows what it is, but can't find the words to say. Cannot carry on a conversation intelligently; headache all over the back of his head/Affecting his balance. In back of head, moves around, sometimes the front; headache all over the back of his head/Affecting his balance. In back of head, moves around, sometimes the front; feeling dizziness/had to stop driving; This is a spontaneous report from a contactable consumer (patient's wife). A 50-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 12Apr2021 (may have been in morning) (Batch/Lot Number: Unknown; Pfizer COVID-19 vaccine) as 2ND DOSE, SINGLE for covid-19 immunization, at the age at vaccination of 50 years old. The patient's medical history and concomitant medications were not reported. History and Investigations: Doesn't take any medications. Has no medical conditions, unless age was considered a medical condition. Historical vaccine included first dose of COVID-19 Vaccine reported as on Third Friday in Feb2021 (First dose: between 1430-1530), and experienced AEs: Brain fog; Headache: Thinks in the back of the head, but moved around too, sometimes in the front. Has affected his balance. Dizziness: Had to stop a couple times while driving home from vaccine facility. Aches and pains. All symptoms from the first dose went away within 3-4 days. Caller would say patient recovered completely from symptoms associated with first dose. The patient experienced nurse stated it could possibly be blood clots on an unspecified date with outcome of unknown, patient is afraid he is going to have a stroke or scared he had one after the covid-19 vaccines on an unspecified date with outcome of unknown, brain fog: at times he can't do the simplest things. he will look at the clock on the wall and says he knows what it is, but can't find the words to say. cannot carry on a conversation intelligently on 12Apr2021 with outcome of not recovered, headache all over the back of his head/affecting his balance. in back of head, moves around, sometimes the front on 12Apr2021 with outcome of not recovered, feeling dizziness/had to stop driving on 12Apr2021 with outcome of not recovered, blurred vision in right eye that comes and goes on an unspecified date with outcome of not recovered, ringing in his left ear on an unspecified date with outcome of not recovered, fullness in face on 12Apr2021 with outcome of not recovered, body aches on 12Apr2021 with outcome of not recovered, very fatigued throughout the day, sleeping a lot/tired and sleeps a lot on an unspecified date with outcome of not recovered, date received first dose: third friday in feb2021/received second dose on 12apr2021, six weeks after first dose on an unspecified date with outcome of unknown. Patient was caller's husband. Had both doses and had the same problem. His experience is very bad with the second dose and has had it for a month. Within a day after the first dose, had brain fog, headache, and dizziness where he had to stop driving a couple times. This went away within a few days. Patient and caller were concerned about the second dose. They spoke with patient's doctor and the local Health Department, both said it couldn't be from the vaccine. Patient was advised to get the second dose. Had the same symptoms with second dose, but occurred within an hour of received second dose. Symptoms have continued. Also experiencing blurred vision in right eye that comes and goes. Patient had an appointment with his doctor this week, but the doctor basically didn't look at him. Doctor advised patient to see a neurologist. Another nurse stated it could possibly be blood clots. Caller is trying to find help. Caller wanted to add with the second dose, patient experienced ringing in his left ear, fullness in his face, and headache all over the back of his head. Was feeling dizziness after second dose and had to stop driving. Patient is afraid he is going to have a stroke or scared he had one after the COVID-19 Vaccines. If the COVID-19 Vaccines woke up some other health issues, patient wants to get it taken care of. Received second dose on 12Apr2021, six weeks after first dose. Got second dose at a different location. Second dose COVID-19 Vaccine AEs: Started experiencing symptoms within an hour. Headache: Affecting his balance. In back of head, moves around, sometimes the front. Comes and goes. Brain fog: At times he can't do the simplest things. He will look at the clock on the wall and says he knows what it is, but can't find the words to say. Cannot carry on a conversation intelligently. Dizziness. Blurred vision in right eye: Doesn't know if this started on 12Apr2021 or a couple days after. States as the day goes on and he gets tired, it will worsen. It comes and goes. Ringing in left ear: Began on 12Apr2021 or a few days after. Fullness in face: Stated this comes and goes, but has stayed the same. Documented as provided. Body aches: Comes and goes. Seems to worsen as the day goes on. Very fatigued throughout the day, sleeping a lot: He's tired and sleeps a lot. It was hard for him to get out of bed. Caller stated patient's symptoms worse as the days goes on. Patient never experienced pain at the injection site. Guesses patient received COVID-19 vaccines in his left arm because the county was doing a dive-thru clinic. Since he didn't get out of his car, she believed patient would have received the vaccines in the left arm. The events REQUIRE A VISIT TO Physician office: Doctor doesn't think anything is wrong. ER: Not yet. Is considering going to the ER today. PRIOR VACCINCATIONS WTIHIN 4 WEEKS was None. RELEVANT TESTS: None. Events Clot blood and stroke considered medically significant. Follow up attempts are needed. Information of Lot/Batch number has been requested.
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| 50 | 2021-05-24 | pain in extremity | Headache, Chills, Fever, Nausea, Left Hallux Pain for 2 days (Gout) |
| 50 | 2021-05-25 | feeling cold |
body felt cold; Tiredness; This is a spontaneous report from a contactable consumer, a patient and o...
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body felt cold; Tiredness; This is a spontaneous report from a contactable consumer, a patient and other healthcare professional. A 50-year-old Male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL3247), via an unspecified route of administration in the right arm on 11Mar2021 at 1300 hours (at the age of 50-years-old), as a first single dose for COVID-19 immunisation. Concomitant medications included Zyrtec and multi vitamins (manufacturer unknown), for an unspecified indication. The patient did not have any allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Mar2021 the patient experienced tiredness and on 16MAR2021, the patient's body felt cold, however patient did not have any fever and was able to maintain his normal schedule of work and exercise. The clinical outcome of the event tiredness was recovering. The clinical outcome of the event felt cold was unknown. No follow-up attempts are possible. No further information is expected.
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| 50 | 2021-05-25 | numbness, tingling |
Left side numbness and tingling, arm, face, back, leg. Also occurred on 4-19 and 5-6, with ER visit...
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Left side numbness and tingling, arm, face, back, leg. Also occurred on 4-19 and 5-6, with ER visits and hospitalization detailed below
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| 50 | 2021-05-25 | pain in extremity |
chills; Nausea; Extreme body pain; Fever; This is a spontaneous case from a contactable consumer, th...
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chills; Nausea; Extreme body pain; Fever; This is a spontaneous case from a contactable consumer, the patient. A 50-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: EL9266) as a first dose in the left arm on 15Feb2021 at 10:30 am and (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: EN6206) as a second dose in the right arm on 08Mar2021 at 13:30 pm via an unspecified route of administration for COVID-19 immunization(age at the vaccination: 50 years). Medical history and concomitant medications are not reported. Prior to the vaccination the patient was not diagnosed with COVOD-19. Since the vaccination, the patient had not been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The facility where the most recent COVID-19 vaccine was administered was at a Clinic. On 15Feb2021, the patient experienced Fever, chills, extreme body aches, nausea for first dose and no side effects for second dose. No therapeutic measures were taken for the events fever, chills, extreme body aches and nausea. The clinical outcome for the events fever, chills, extreme body aches, nausea are recovered on an unknown date. The patient feels like he didn't get a second dose or something was wrong with the second dose as he did not experience with any events. No follow-up attempts are needed. No further information is expected.
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| 50 | 2021-05-25 | speech disorder, bell's palsy |
On 04/25/21, my face felt like I was having an allergic reaction, but wife couldn't understand my sp...
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On 04/25/21, my face felt like I was having an allergic reaction, but wife couldn't understand my speech. So, we rushed to hospital (emergency room) and Dr diagnosed Bell's Palsy. Recommended I see a neurologist. Neurologist confirmed the diagnosis.
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| 50 | 2021-05-26 | pain in extremity |
I received the first dose of the Pfizer-BioNTech COVID-19 Vaccine EUA on 3/31/21. My arm soreness n...
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I received the first dose of the Pfizer-BioNTech COVID-19 Vaccine EUA on 3/31/21. My arm soreness never subsided by the day of my second dose, which was on 4/24/21 at 12:00 p.m. Here we are on 5/27 & the soreness still has not gone away. It's been 8 weeks and it's actually gotten worse the last 2-3 days. I can't find information on this particular situation anywhere. My arm is not swollen or red and there are no hard bumps or anything like that in the area. It's just sore whenever I move it. This is not right. Please let me know what to do.
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| 50 | 2021-05-26 | pain in extremity | Throwing up, very sore arm happened 20 mins after getting it |
| 50 | 2021-05-26 | tremor |
Site: Pain at Injection Site-Mild, Systemic: Arm Shaking after-Mild, Additional Details: Arm shaking...
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Site: Pain at Injection Site-Mild, Systemic: Arm Shaking after-Mild, Additional Details: Arm shaking told patient to do cold compress
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| 50 | 2021-05-26 | tremor |
High fever 103.5 for about 15 hours then low grade fever 100+ for the next 24 hours with chills and ...
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High fever 103.5 for about 15 hours then low grade fever 100+ for the next 24 hours with chills and shakes. Headache for 5 days and fatigue for 4 days.
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| 50 | 2021-05-29 | pain in extremity | Fever up to 101.4, left arm soreness, fatigue, drowsiness |
| 50 | 2021-06-01 | muscle twitching |
twitching in the muscle in his right arm, which is the arm he got the shot in; positive COVID-19 tes...
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twitching in the muscle in his right arm, which is the arm he got the shot in; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for different doses. This is the first of two reports. A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in arm right on 02Apr2021 reported as at 1600 or 1700 (Batch/Lot Number: ER8732) at the age of 50 years old as 1st dose, single dose for COVID-19 immunization. Medical history was none. There were no concomitant medications. The patient received the 1st and 2nd dose of PFIZER-BIONTECH COVID-19 VACCINE. He experienced twitching in the muscle on Apr2021. It has not gone away. He received both doses of the vaccine. With the first dose, the patient experienced positive covid-19 test with symptoms. He had headache and diarrhea on Apr2021, fever and tired/fatigue on 05Apr2021, muscle aches and pains on 06Apr2021. He had the first dose on 02Apr2021 (Friday). He tested positive for COVID on 09Apr2021. One of the side effects that he has been getting and still has is twitching in the muscle in his right arm, which is the arm he got the shot in. He was asking if this has been reported in anyone else and wanted to know what the timeframe is before it wears off. Headache started Monday or Tuesday and recovered by Friday (Apr2021). Diarrhea started Thursday or Wednesday and recovered by Friday (Apr2021). Fever started Monday night (05Apr2021) and recovered by Friday (09Apr2021). The twitching in his right arm started two weeks after the first shot (Apr2021) and has been more steady the last couple of days - it had worsened. He recovered completely from COVID about a week after symptoms started. No additional vaccines administered on same date. No visit to Emergency Room not Physician Office required. Prior Vaccinations (within 4 weeks) was none. Outcome of event positive covid-19 test with symptoms was recovered on Apr2021, while other event was not recovered. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021503563 same patient, similar event; different dose
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| 50 | 2021-06-02 | tremor |
Patient started shaking a lot 5 minutes after vaccination. Checked Vitals and his BP was 241/212,SpO...
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Patient started shaking a lot 5 minutes after vaccination. Checked Vitals and his BP was 241/212,SpO2 was 98. Called 911 and patient was taken to the hospital. BP dropped to 171/117 when EMS came in and checked.
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| 50 | 2021-06-03 | bell's palsy | G51.0 - Bell's palsy |
| 50 | 2021-06-03 | pain in extremity |
Continue with pain in left arm since April 20, I am taking 2 Advil Avery day to control the pain wai...
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Continue with pain in left arm since April 20, I am taking 2 Advil Avery day to control the pain waiting to the pain let go, but not happening, and I and starting to worry
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| 50 | 2021-06-05 | night sweats |
I had experienced several Adverse Events after getting the Covid 19 Vaccine. I had Pain at the Inje...
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I had experienced several Adverse Events after getting the Covid 19 Vaccine. I had Pain at the Injection site on my Left arm a few hours after receiving the vaccine at 11:00 am on 6/5/21. Initially I did not feel anything. However the Pain got worse thruout the day until I went to bed at night. The Injection site also was a little swollen after a few hours of getting the vaccine. I had experienced some fatigue and tiredness on 6/5/21 after getting the vaccine. When waking up in the morning on 6-6-21 I must of had fever at night because in the morning I was sweaty. I also felt tired and fatigued when waking up. The pain at the injection site seems to have gotten a little better. Also there is no fever or sweating after i woke up.
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| 50 | 2021-06-07 | bell's palsy | Bells Palsy |
| 50 | 2021-06-07 | burning sensation |
BPPV; burning sensation; partial loss of hearing; fullness and burning sensation in ears; tinnitus; ...
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BPPV; burning sensation; partial loss of hearing; fullness and burning sensation in ears; tinnitus; brain fog; pressure in the back of my head; severe vomiting; shortness of breath; Pyrexia; Mental status changes; This is spontaneous report from contactable consumer (patient). A 50-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 21Apr2021 14:30 (Batch/Lot Number: EWO161), at the age of 50 years, as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Previously the patient received first dose of bnt162b2 on 30Mar2021, at the age of 50 years, Time: 03:45 PM, Lot no. EW8730, anatomical location: Left arm. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 30Apr2021 19:30 the patient experienced Benign Paroxysmal Positional Vertigo (BPPV) (hospitalization, life threatening). On 30Apr2021 19:30 the patient experienced fullness and burning sensation in ears, tinnitus, brain fog, pressure in the back of head, severe vomiting, shortness of breath, pyrexia, mental status changes. On 12May2021 the patient experienced partial loss of hearing. On 28May2021 the patient experienced burning sensation. Clinical course: Nine days after taking a second dose of the Pfizer vaccine it started with multiple episodes of vertigo for 2 days, followed by severe vomiting, non-stop vertigo, shortness of breath. Taken into Emergency Room (ER) by ambulance on 02May2021, multiple tests performed (CT scan, blood, EKG) diagnosed with BPPV. Discharged the same night. The symptoms escalated into fullness and burning sensation in ears, partial loss of hearing, tinnitus, brain fog, pressure in the back of my head. Went to primary care physician on 05Jun2021, again multiple tests (blood, urine, EKG). Referred to ENT. Visited ENT on 12May2021, audiology test confirmed partial hearing loss. On 28May2021 the patient was still suffering with burning sensation and fullness in the right ear, as well as loss of hearing (high frequencies) and tinnitus. Periodic episodes of brain fog and severe vertigo. The patient underwent lab tests and procedures which included blood test: diagnosed with BPPV on 02May2021, blood test: unknown results on 06May2021, CT scan: diagnosed with BPPV on 02May2021, electrocardiogram: diagnosed with BPPV on 02May2021, electrocardiogram: unknown results on 06May2021, audiology test: partial hearing loss on 12May2021, urine output: unknown results on 06May2021. The patient received treatments due to the events: Diazepam, Meclizine, Potassium Chloride, Metoclop. The outcome of the events was not recovered.
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| 50 | 2021-06-07 | numbness |
Severe worsening of tinnitus. I don't remember exactly when but it was it was very noticeable the fo...
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Severe worsening of tinnitus. I don't remember exactly when but it was it was very noticeable the following day after receiving the first shot (and very possibly that night) and continued to worsen for the next few days. I've have very mild tinnitus most of my life, however this is *far* worse than anything I have ever experienced (can hear it very clearly over day-time background noise, conversations, etc. whereas before could only hear it when it was relatively quiet.) It has been 3 weeks and has not abated, and in fact is probably continuing to grow worse. It is probably noteworthy that within minutes of receiving the shot, a got quite light headed and my face felt slightly numb for a period of an hour or two. These symptoms went away, however the tinnitus has not.
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| 50 | 2021-06-09 | tingling, numbness |
When I first got the shot, my left arm and leg went numb and was tingling. About a day later, my who...
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When I first got the shot, my left arm and leg went numb and was tingling. About a day later, my whole body started feeling stiff like I could not move. On Feb. 23, I went to the ER. They drug test (negative), blood work, and some x-rays. They could not find out what is causing this.
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| 50 | 2021-06-10 | tingling | Site: Pain at Injection Site-Medium, Systemic: Tingling (specify: facial area, extemities)-Mild |
| 51 | 2021-01-02 | tremor |
Dizziness, shortness of breath, swollen hands and fingers, shaky blurred vision. all occurred 2 hour...
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Dizziness, shortness of breath, swollen hands and fingers, shaky blurred vision. all occurred 2 hours after giving the shot. Patient was given benadryl and felt better in about 1 hour, he went home and the next day came back to work normal
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| 51 | 2021-01-04 | burning sensation |
I felt as if I had blow torches during the 2 hour mark on the lateral thighs, femur bone pain and hi...
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I felt as if I had blow torches during the 2 hour mark on the lateral thighs, femur bone pain and hip pain.
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| 51 | 2021-01-04 | facial paralysis, face paralysis |
Patient developed tingling on the tongue 7 days after vaccine and developed unilateral facial weakn...
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Patient developed tingling on the tongue 7 days after vaccine and developed unilateral facial weakness 9 days later diagnosed as bell's palsy and started on Prednisone, Valcyclovir and ophthalmic Lubricants.
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| 51 | 2021-01-05 | pain in extremity | Myalgia Pain at injection site and arm |
| 51 | 2021-01-09 | weakness | Fever close to 102, rigors, aches, fatigue, overwhelming weakness |
| 51 | 2021-01-09 | pain in extremity |
3 hours after 2nd dose almost fainted when exercising. 4 hours after injection started to feel ache...
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3 hours after 2nd dose almost fainted when exercising. 4 hours after injection started to feel achey, headache, and stiff neck. 12 hours after injection started shivering and increased heart rate. Took advil which helped, but shivering resumed 18 hours later. Took more advil. Body aches, sore arm, and headache continued for 48 hours. I still don't feel great 48 hours later but much better
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| 51 | 2021-01-10 | feeling hot, flushing |
Very hot, flush, stomach upset, sweating, increased respiratory rate, slouched in chair, chills over...
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Very hot, flush, stomach upset, sweating, increased respiratory rate, slouched in chair, chills over face/neck
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| 51 | 2021-01-11 | numbness, tingling |
30 min after injection, right arm and hand suddenly felt tingly and a bit numb (like it was "asleep"...
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30 min after injection, right arm and hand suddenly felt tingly and a bit numb (like it was "asleep"). The sensation moved to shoulder, traps, and face after about 30-45 minutes; 30 min after injection, right arm and hand suddenly felt tingly and a bit numb (like it was "asleep"). The sensation moved to shoulder, traps, and face after about 30-45 minutes.; numbness/tingling mostly right side (arm, shoulder, face); This is a spontaneous report from a contactable consumer, the patient. A 51 -year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, 0.3 mL, lot number: EL0140), via an unspecified route of administration on 05Jan2021 at 05:30 PM, (at the age of 51 years-old) as a single dose in the right arm for COVID-19 vaccination. Medical history included Hashimoto's thyroiditis, hypertension and asthma. The patient was allergic to gadolinium MRI contrast, morphine (plus standard environmental allergies). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included allergy shots weekly, vitamin C, vitamin D3 and zinc quercetin. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 05Jan2021 at 06:15 PM, (also reported as 30 min after injection), the patient's right arm and hand suddenly felt tingly and a bit numb (like it was "asleep"). The sensation moved to the shoulder, traps, and face after about 30-45 minutes. The sensation started to subside after about 3-4 hours. There was never ever any weakness or sensation of throat, hives or rash, breathing issues or pain at injection site. Just a numbness/tingling mostly right side (arm, shoulder, face). The lower extremities or left side was not affected. The events were reported as non-serious. Laboratory data included a COVID-19 test (nasal swab) on 15Oct2020 which was negative. The patient was not treated for right arm and hand suddenly felt tingly and a bit numb (like it was "asleep"), the sensation moved to the shoulder, traps, and face. right arm and hand suddenly felt tingly and a bit numb (like it was "asleep"), sensation moved to the shoulder, traps, and face. The clinical outcome of right arm and hand suddenly felt tingly and a bit numb (like it was "asleep"), sensation moved to the shoulder, traps, and face was recovering. It was also reported that since the vaccination, the patient has been tested for COVID-19 (nasal swab) on 15Oct2020 .
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| 51 | 2021-01-11 | pain in extremity |
got home from the shot at 1145a. Fell asleep until 930pm. During sleep was told by family that i was...
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got home from the shot at 1145a. Fell asleep until 930pm. During sleep was told by family that i was angry, cursing and yelling in my sleep. I don't remember any of it , i felt delirious and out of co; got home from the shot at 1145a. Fell asleep until 930pm. During sleep was told by family that i was angry, cursing and yelling in my sleep. I don't remember any of it , i felt delirious and out of co; got home from the shot at 1145a. Fell asleep until 930pm. During sleep was told by family that i was angry, cursing and yelling in my sleep. I don't remember any of it , i felt delirious and out of co; got home from the shot at 1145a. Fell asleep until 930pm. During sleep was told by family that i was angry, cursing and yelling in my sleep. I don't remember any of it , i felt delirious and out of co; Left arm was extremely painful; This is a spontaneous report from a contactable Other-HCP. A 51-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number # EL1284) on 02Jan2021 at 10:00 AM at single dose via intramuscular on left arm for COVID-19 immunization. Medical history included allergy to codeine hypertension and asymptomatic HIV infection. Concomitant medications were not reported. Patient got home from the shot on 02Jan2021 at 11: 45 am. Fell asleep until 930p:m. During sleep was told by family that He was angry, cursing and yelling in his sleep. He didn't remember any of it, He felt delirious and out of control. Left arm was extremely painful. At the time of the reporting had recovered from the events without any treatment.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported event delirious cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 51 | 2021-01-12 | pain in extremity |
tachycardia (HR110-120); left arm soreness; This is a spontaneous report from a contactable physicia...
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tachycardia (HR110-120); left arm soreness; This is a spontaneous report from a contactable physician (patient). A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular at the left arm on 16Dec2020 14:00 (lot number: EH9899) at a single dose, then intramuscular at the left arm on 05Jan2021 16:00 (lot number: EK9231) at a single dose for COVID-19 immunization in the hospital. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient medical history was not reported. The patient has no allergies to medications, food, or other products. Concomitant medications included allopurinol and atorvastatin. The patient experienced left arm soreness and tachycardia with hr of 110-120 on 06Jan2021 16:30. No treatment was given in response to the events. The patient assessed the events as non-serious. The outcome of the events was not recovered. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since vaccination.
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| 51 | 2021-01-14 | flushing | Whole body aches from head to toes, chills , flushing, diarrhea, low grade fever |
| 51 | 2021-01-14 | pain in extremity |
fluctuating Temperatures up to 103.7 Painful Body aches throughout all joints Chills Symptoms laste...
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fluctuating Temperatures up to 103.7 Painful Body aches throughout all joints Chills Symptoms lasted 36 hours Right leg fluctuating tissue/faccia pain lasting 2+weeks, MD states related to virus/vaccine
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| 51 | 2021-01-18 | weakness |
headaches; Right deltoid is very tender to touch at injection site; A little weak feeling running to...
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headaches; Right deltoid is very tender to touch at injection site; A little weak feeling running to right shoulder blade; This is a spontaneous report from a contactable pharmacist reporting for himself. A 51-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL1284), intramuscular (right arm) on 08Jan2021 07:15 at SINGLE DOSE for COVID-19 immunization. The patient's other medical history was not reported. The vaccine was given at hospital. No other vaccines in four weeks. Patient did not have COVID-19 prior vaccination and was not tested for COVID-19 after vaccination. Patient has no known allergies. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot: EJ1685) on 21Dec2020 07:15, left arm at single dose and experienced headaches, general malaise, moderate soreness at left deltoid running down thru left shoulder and mid back on 21Dec2020 18:00, with no treatment given. Concomitant medication included krill oil and an unspecified multivitamin; unspecified dates and indication. On the second vaccine, patient experienced same headaches starting the evening of after getting second vaccine on 08Jan2021. Patient also experienced headaches feel exactly the same as before, seemingly in the middle, top half of head, right deltoid is very tender to touch at injection site, and a little weak feeling running to right shoulder blade all on unspecified date in Jan2021. No treatment was given. Outcome of the events was unknown. The reporter assessed the events as non-serious.
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| 51 | 2021-01-18 | seizure |
APPROXIMATELY 5 MIN AFTER RECEIVING VACCINE, IN OBSERVATION, BEGAN TO HAVE A SEIZURE. FELL ONTO STA...
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APPROXIMATELY 5 MIN AFTER RECEIVING VACCINE, IN OBSERVATION, BEGAN TO HAVE A SEIZURE. FELL ONTO STAIRS IN THEATER-LIKE SEATING. CARE WAS IMMEDIATELY REDERED BY RNS, A CODE BLUE WAS CALLED. CODE TEAM ATTENDED TO PATIENT AND SUBSEQUENTLY TOOK TO THE EMERGENCY DEPARTMENT.
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| 51 | 2021-01-18 | seizure |
ABOUT 5 MINUTES AFTER RECEIVING VACCINE, PATIENT BEGAN SEIZURE. PATIENT FELL TO FLOOR FROM CHAIR. ...
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ABOUT 5 MINUTES AFTER RECEIVING VACCINE, PATIENT BEGAN SEIZURE. PATIENT FELL TO FLOOR FROM CHAIR. OBSERVING RN'S PROVIDED IMMEDIATE CARE. A CODE WAS CALLED. CODE TEAM TREATED PATIENT, THEN TOOK TO EMERENCY DEPARTMENT.
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| 51 | 2021-01-19 | weakness, tingling, numbness |
2 days after 1st dose: severe headache and body aches. Severe tinnitus. Insomnia, constipation. Afte...
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2 days after 1st dose: severe headache and body aches. Severe tinnitus. Insomnia, constipation. After 3 days tingling numbness and weekends in extremities. Loss of appetite. Weight loss. Symptoms persisting for 3 weeks.
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| 51 | 2021-01-20 | weakness |
Uncontrollable rigors; profound fatigue; weakness; achiness; nausea; fever (up to about 102).; This ...
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Uncontrollable rigors; profound fatigue; weakness; achiness; nausea; fever (up to about 102).; This is a spontaneous report from a contactable physician reporting for himself. A 51-year-old male patient received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL3246, expiry date not reported) on 09Jan2021 at 08:30 via an unspecified route of administration in the left arm for COVID-19 immunization. The patient's medical history included penicillin allergy. No other medical history. The patient had not had COVID prior to the vaccination and had not been tested post the vaccination. The patient had received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EJ1685, expiry date not reported) on 19Dec2020 at 16:30 via an unspecified route of administration in the left arm for COVID-19 immunization. No other vaccine received in four weeks. Concomitant medication included paracetamol (TYLENOL). On 09Jan2021 at 23:30, the patient experienced uncontrollable rigors, profound fatigue, weakness, achiness, nausea, fever (up to about 102). The events were non-serious. The patient took over the counter paracetamol (TYLENOL) and ibuprofen for the events, and was recovering from the events.
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| 51 | 2021-01-21 | slurring |
pt had severe, non-hospitalized covid infection late August: fever, loss of taste/smell, fatigue, dy...
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pt had severe, non-hospitalized covid infection late August: fever, loss of taste/smell, fatigue, dyspnea, cough; recovered all except smell /taste loss has improved but not normal; covid Ab positive in November; After the injection he began with chills that night around 3 am. The next day he felt ataxic, hit a curb twice while driving, was slurring speech; those sx's resolved over the next few hours; fatigue persisted for the next 48 hours.
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| 51 | 2021-01-22 | pain in extremity | fever, chills, arm pain, fatigue but mainly swollen lymph nodes continuing to swell for two days |
| 51 | 2021-01-24 | muscle spasms, pain in extremity |
I had a sore arm for about two days after receiving my second shot with mild tiredness. On the 22nd ...
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I had a sore arm for about two days after receiving my second shot with mild tiredness. On the 22nd of January I work up around 2:30 with severe cramp and joint. I could even close my hands because my nuckles were so sore. I hand a temperature of 101 degrees. On the 25 I?m moving around but very sore but is getting better everyday. I spent the entire day though resting in bed.
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| 51 | 2021-01-25 | facial paralysis |
14th of jan i had a pain around my jaw got up the next day i started having water eyes, the right si...
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14th of jan i had a pain around my jaw got up the next day i started having water eyes, the right side of face started to droop. went to ER and was diagnosed with Belspaulsy. after that did a follow up appointment with neurology
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| 51 | 2021-01-25 | flushing, tingling, pain in extremity, feeling hot, feeling cold, muscle twitching |
Dose 1 -Muscle twitched on injection into R deltoid. Immediately after injection experienced warm a...
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Dose 1 -Muscle twitched on injection into R deltoid. Immediately after injection experienced warm and cold sensations through right arm, intermittent pains along arm. Was asked to be observed 30 mins post injection. Sent home. Paresthesias (intermittent warm, cold, tingling sensations) continued with radiation into right axillary, and into neck. Experienced intermittent facial tingling. On day 3 post injection, started with burning eye discomfort in right eye. Went to eye doctor to rule out eye infection. No eye infection, Instructed to use Refresh drops. In 4 days subsided. Day 7 experienced ear flushing and warmth that last 3 days and subsided. Saw a neurologist to rule out nerve damage. EMG was normal. ANA titer was 1:40 with speckled and cytoplasma pattern. My last ANA was negative when tested for inflammation due to back pain few years prior. Neurologist did not think this was an allergic reaction and since symptoms were gradually improving recommended second dose. Symptoms fully resolved after 2 weeks Dose 2 - Jan 19 , 2021 (21 days post) - Decided to inject left deltoid to avoid trauma to right arm. Was observed 30 mins and released. No symptoms. Moderate arm soreness x 4 days. Day 3 post injection developed burning eye discomfort, intermittent tingling sensation in arm, warm/cold sensations. Pain radiating to shoulder and neck. Day 6 started very mild tingling and warm sensations in in cheek and chin area. Also experienced intermittent prickly sensations in throat and sensation of throat tightness predominantly on left side. (but no actual swelling). Today (Jan 26, 2021) is Day 7 and these intermittent sensations are persisting. Arm soreness has resolved. Right eye burning discomfort improving.
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| 51 | 2021-01-26 | pain in extremity, discomfort |
he had 102.1 temp; he started not feeling well; chills; ringing in ears/ The ringing was in both ear...
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he had 102.1 temp; he started not feeling well; chills; ringing in ears/ The ringing was in both ears; body aches; joint aches; fatigue; lymphadenopathy/had swollen lymph nodes like the size of an apple; he was uncomfortable; His eyes were also hurting; The light bothered his eyes; This is a spontaneous report from a contactable Other HCP (patient) and a contactable Nurse (patient's wife). A 51-year-old male patient received the 2nd dose of bnt162b2 (BNT162B2, Batch/lot # EL3246, Expiry Date Apr2021) at single dose at left arm on 11Jan2021 18:00 for Covid-19 immunisation, administered at hospital as being a certified registered nurse anesthetist (CRNA). The patient medical history was none. There were no concomitant medications. The patient received the 1st dose of bnt162b2 (BNT162B2, lot # EK5730, expiry: 31Mar2021) at single dose at left arm on 23Dec2020 for Covid-19 immunisation and he has been fine, no adverse effect occurred. No additional vaccines administered on same date of BNT162B2. The patient experienced lymphadenopathy which is a size of tennis ball under my left armpit /had swollen lymph nodes like the size of an apple in his left arm in the axillary area, where he received the vaccine on 12Jan2021, he started not feeling well on 12Jan2021 around 9.00, he had 102.1 temp Fahrenheit on 12Jan2021 17:00, chills on 12Jan2021, ringing in ears/ the ringing was in both ears on 12Jan2021, body aches on 12Jan2021, joint aches on 12Jan2021, fatigue on 12Jan2021, his eyes were also hurting on an unspecified date in Jan2021, the light bothered his eyes on an unspecified date in Jan2021. The patient underwent lab tests and procedures which included body temperature: 102.1 fahrenheit on 12Jan2021, he was uncomfortable on 12Jan2021, body temperature: 100 and something fahrenheit on 13Jan2021. The outcome of lymphadenopathy/had swollen lymph nodes like the size of an apple was worsened, of he had 102.1 temp, ringing in ears/ the ringing was in both ears was not recovered, he started not feeling well, his eyes were also hurting, light bothered his eyes was unknown, chills, body aches, joint aches, fatigue was recovered on 13Jan2021. Course of events: Around 9AM on 12Jan2021 he started not feeling well. By the time he got home from work he had 102.1 temp Fahrenheit around 5PM. Temp was ongoing. His eyes were also hurting. The light bothered his eyes. He can't put his arm down. His left arm in the axillary area, where he received the vaccine, had swollen lymph nodes like the size of an apple. He had chills, ringing in ears, body aches and joint aches, and fatigue 12Jan2021. He was uncomfortable. The ringing was in both ears. On 13Jan2021 his temp was one hundred and something. What is concerning was the swelling in the armpit in the arm he received the vaccine in. It was very painful. It was starting to radiate up his arm. He did not go to the doctor, since he was relatively healthy. No event required a visit to Emergency Room or Physician Office. The reporting Nurse assessed the events he had 102.1 temp, His left arm in the axillary area, where he received the vaccine, had swollen lymph nodes like the size of an apple as serious as medically significant. The reporting Nurse assessed the events he had 102.1 temp, His left arm in the axillary area, where he received the vaccine, had swollen lymph nodes like the size of an apple, chills, Ringing in ears, body aches and joint aches, and Fatigue as related to BNT162B2.; Sender's Comments: Based on a compatible temporal association and known product safety profile, causality between events lymphadenopathy and fever and BNT162B2 COVID-19 vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 51 | 2021-01-28 | tingling | sharp pain in shoulder blades that radiates, tingling in right hip |
| 51 | 2021-01-29 | pain in extremity, feeling cold |
Began with a slight headache that eventually got worse. Started, when treated, at a 5 of 10. Left ...
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Began with a slight headache that eventually got worse. Started, when treated, at a 5 of 10. Left facility with a 7 of 10 headache. Then I had a weird taste in my mouth (metallic like). My tongue started to tingle and was a bit numb. Eventually after Doctor at facility took me in, I was given benedryl 50 mg and an antacid. After a few minutes the right side of my mouth became itchy but the tingling stopped. The itch was not unbearable but it was getting there. I was already having a slight difficulty breathing but that was from the morning even with inhalers. As an instrument player a doctor said I have super lungs so my results would be skewed due to how much air I take in. But any loss of air, although in the safe range for others, is like breathing through a straw for me. My blood pressure was 139/90 at the time. My normal blood pressure is 117/70. I went home feeling cold and just not feeling well, relatable to flu symptoms. This is the next day after taking benedryl every 6 hours at 50mg/dose. My breathing is slightly labored. I feel ok but my arm hurts, I have been moving it around a lot just to get it mobile. My chest feels like there is a slight weight on it which is weird for me. At the moment my pulse is 81bpm and my oxygen is at around 96. My norm is around 70bpm and oxygen at 99. No temperature is consistent at 97.3. I feel a little weird today. I am stiff all over as well. Little aches here and there but that is a norm. Doing my stretches and exercise is not a go today. Can't breathe as normal.
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| 51 | 2021-01-31 | bell's palsy, facial paralysis |
I am a pediatric critical medicine physician and received my COVID-19 vaccine at my workplace. 1st ...
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I am a pediatric critical medicine physician and received my COVID-19 vaccine at my workplace. 1st Pfizer EH9899 (on Dec 18, 2020) and 2nd Pfiszer EL1283 (on Jan 9, 2021). Both IM through my left arm. Directly for about less 48H post vaccination I had muscle pain that were self-resolved. On Jan 18, 2021, I started having funny sensation (like having a foreign body) over my left eye medial /innercantus area. The next 2 days I started to have pain over my left external ear canal, then it progressed into pain over my left lower jaw, left vertex of my head, inner side of left eye. My SS progressed on 1/30/21 at around 3:30 PM to numbness over my left sided tongue and left sided lip. Then on 1/31/21 at around 5 AM, I started having left facial paralysis. I have left BELL's PALSY which was confirmed. following a negative non-contrast brain MRI to rule out stroke and negative SARS-CoV2 PCR test. I start taking Prednisone 60 mg daily and Acyclovir 1 g TID on Jan 31, 2021. To this date I still have left facial paralysis but not worsening.
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| 51 | 2021-02-06 | bell's palsy | Left Bell's palsy (unable to close eyelid all the away, tearing, left facial drooping) |
| 51 | 2021-02-08 | cold sweat |
Approx 14 minutes after receiving the vaccine, client felt like his heart was racing and his blood p...
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Approx 14 minutes after receiving the vaccine, client felt like his heart was racing and his blood pressure elevated, and dizzy. vital signs monitored, his BP was 150/108. He was clammy and shaky He was taken behind the white curtain and took his mask off, which he said helped tremendously. He was monitored. BP down to 140/100. He recently started BP medication. Told to discuss this episode with his PCP.
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| 51 | 2021-02-08 | pain in extremity | Sore arm |
| 51 | 2021-02-20 | flushing, feeling hot |
Systemic: Chills-Mild, Systemic: Ringing in ears, chills,then feeling flushes. No obvious signs of ...
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Systemic: Chills-Mild, Systemic: Ringing in ears, chills,then feeling flushes. No obvious signs of diaphoresis-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Hypertension-Medium, Systemic: Tinnitus-Mild, Additional Details: Report. 20 min post admin, Aid ckd BP and reported 204/134. Rpt ringing in ears, chills, then warm sensation all over. BP 5-10 min later in other arm, reported 213/162. Gave Pt water. COO at facility to call paramedics to assess. Lied pt down for 5 min, rck BP 180/117. Pt reported feeling fine w/ occasional chill. Waiting on Paramedics. Approx 5 min, pt sat up complaining of headache. Paramedic arrived about 5 minutes later, assessed pt, bp 232/120?. To Hospital
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| 51 | 2021-02-22 | tingling |
Itchy and tingly hands/arms in morning of 2/22/21. Rash broke out on body in the evening (face, leg...
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Itchy and tingly hands/arms in morning of 2/22/21. Rash broke out on body in the evening (face, legs, shoulders, waist, thighs/groin). Took a Benadryl and ibuprofen. Symptoms improved by morning, but still evidence of the rash. Took normal allegry meds in AM. Will monitor symptoms moving forward.
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| 51 | 2021-02-23 | pain in extremity |
Started being more fatigue and right arm stays sore everyday in the bend shoulder on right side stay...
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Started being more fatigue and right arm stays sore everyday in the bend shoulder on right side stays sore
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| 51 | 2021-02-25 | tingling |
swollen lymph node under his left arm; I feel tingling in my arm; I turn my neck to the right side, ...
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swollen lymph node under his left arm; I feel tingling in my arm; I turn my neck to the right side, I feel like little pain on the neck side; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EK9231) via an unspecified route of administration on 23Jan2021 at a single dose for COVID-19 immunization. Medical history included blood pressure (abnormal) and diabetes. Concomitant medication included lisinopril for blood pressure, amlodipine, atorvastatin and metformin for diabetes. The patient previously received first dose of BNT162B2 on 02Jan2021 for COVID-19 immunization. The patient had his second shot of his COVID 19 vaccine and then the first day was okay but the second day (24Jan2021) was, he had like swollen lymph node under his left arm. And also, he felt tingling in his arm. And when he turned his neck to the right side, he felt like little pain on the neck side. "I don't know if this will go away or what. This is the third day I had the vaccine." Consumer stated, "I took Ibuprofen." The patient underwent lab tests and procedures which included lab on an unspecified date with unknown results (the patient don't have it, his primary care have it). Outcome of the events was not recovered.
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| 51 | 2021-02-25 | seizure |
At about 2am on 2/10/21, Patient got up from bed and fell down a flight of stairs. He was initially ...
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At about 2am on 2/10/21, Patient got up from bed and fell down a flight of stairs. He was initially bleeding and unconscious and was brought by EMS to the hospital. Upon arrival at the hospital he had a temperature of 40 C. He was found to have 2 small left temporal hemmorhagic contusions on CT scan. He had a seizure during the hospitalization. He was initially treated for HSV encephalitis but it is not clear if that was confirmed. The hospital team may not have known of the recent vaccination. He improved during the hospitalization, but remained with a very unsteady gait. He could not return to the group home. He was transferred to a rehab facility to receive PT on 02/16/2021. He remains at rehab. Prior to the fall, on the 3rd day after vaccination, on 2/8/21 at about 10 am, the patient coughed and had a small blood on the inside of his face mask while at his day program. He was seen by his PCP and had no abnormal findings. He had a CBC, BMP and CXR and all were unremarkable.
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| 51 | 2021-02-28 | tingling | Patient noted tingling to LUE and tongue swelling, no other symptoms. |
| 51 | 2021-03-02 | bell's palsy | Bell's Palsy |
| 51 | 2021-03-03 | weakness |
Dizziness/felt woozy/light headed; Weakness; vision changed; increased heart rate/heart rate went up...
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Dizziness/felt woozy/light headed; Weakness; vision changed; increased heart rate/heart rate went up slightly; had pressure in his head; pressure in his hands and feet like he could not move his feet; pressure in his hands and feet like he could not move his feet; headache; muscle tightness/muscles tightened in his back and in his calf muscles/tightness in his neck; he felt like he was just not himself; lethargic; lump in his throat; lymph nodes got tight on the same side as the vaccine/lymph node on his left side was tight throughout his neck; cringing in his stomach muscles; kind of like a muscle spasm in his stomach; didn't sleep that well last night; wobbly; back was hurting; muscle pain; This is a spontaneous report received from a contactable consumer (patient). A 51-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EZ9261, expiry date: unknown), via an unspecified route of administration, from 01Feb2021, at single dose, for COVID-19 immunization. Medical history included anemia (anemic), inflammation, acid reflux (esophageal), pain, on blood thinner, high cholesterol, sinus disorder (sinuses), overactive bladder/bladder control, acid reflux, stools hard (to soften stool), nerves, blood pressure high (high bp), car accident, and costochondritis in chest. Concomitant medication included atorvastatin calcium for high cholesterol from an unspecified date and ongoing; docusate sodium to soften stool; famotidine to soften stool from an unspecified date and ongoing; garlic [allium sativum] as blood thinner from Nov2020 (3 months ago) and ongoing, gabapentin for nerves from an unspecified date to an unspecified date and from Nov2020 (got back on this 3 months ago) and ongoing; hydrocodone for pain; iron for anemia from Nov2020 (been taking this for the last 3 months) and ongoing; meloxicam for inflammation, omeprazole (PROTONIX) for acid reflux from an unspecified date and ongoing; tadalafil for overactive bladder/bladder control from an unspecified date and ongoing; vitamin c (ascorbic acid), colecalciferol (VITAMIN D), vitamin b for trying to build up his immune system; ranitidine hydrochloride (ZANTAC) for sinuses; "One a Day Men's" from 2016 and "50+" (as reported, pending clarification). On 01Feb2021, after the shot, the patient experienced dizziness/felt dizzy and had weakness. When he walked to the desk to check out he felt his vision changed and his heart rate went up slightly but it did go down once he sat down but he felt woozy and had pressure in his head and pressure in his hands and feet like he could not move his feet. He was kind of like dizzy and light headed. He walked somewhere to sit down, he stayed 30 minutes and left after and sat 30 minutes in the car and he got a headache and his muscles tightened in his back and in his calf muscles and he felt like he was just not himself. He felt lethargic and felt like his lymph node on his left side was tight throughout his neck. He felt like his lymph node was getting tight and he just sat until he felt like his symptoms had dissipated. He also had lump on his throat. He had stuff going on with his stomach like cringing in his stomach muscles, it was kind of like a muscle spasm in his stomach. He didn't sleep that well last night (01Feb2021) as he felt some symptoms come on again, the tightness in his neck again and when he sat up, he got dizzy and wobbly, his back was hurting, his calf muscle was tight. He felt more muscle pain. He checked his blood pressure and it was good, but he just felt a little dizzy on 02Feb2021. The patient stated that all his symptoms have improved since 01Feb2021. The patient also mentioned that the girl looked really young (referring to the person who administered the vaccine), "maybe she jacked it up, he knows it supposed to be a very little bit, maybe she put more in him than she was supposed to". He went back to his doctor as he wants to come off of some of his medications because he is supposed to have another shot and he want to take the second shot. He wanted to stop taking all the medications around the second shot in case it was his medications that caused it. The patient asked since he had complications with the fist dose, should he still take the second dose. The patient was recovering from the events.
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| 51 | 2021-03-03 | weakness |
Patient felt weak and lightheaded immediately after receiving vaccine Heart Rate increased to 122 BP...
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Patient felt weak and lightheaded immediately after receiving vaccine Heart Rate increased to 122 BPM. BP 180/80. Other vital signs normal After 45m obs v/s HR 96 O2 98% room air, PB 110/60. Patient stated she felt she felt too sick for discharge home and requested EMS be called. EMS responded and xported to hosp
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| 51 | 2021-03-03 | numbness, tingling |
Numb and tingly face; Numb and tingly face; Fatigued; lethargic; This is a spontaneous report from a...
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Numb and tingly face; Numb and tingly face; Fatigued; lethargic; This is a spontaneous report from a contactable consumer (patient). A 51-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EN 5318), via an unspecified route of administration left arm single dose on 02Feb2021 14:30 (at the age of 51) for covid-19 immunisation. The patient medical history included covid 19 with mild symptoms on 29Dec2020. The patient's concomitant medications were not reported. No other vaccine was received in four weeks. The patient experienced numb and tingly face, both on 02Feb2021 18:00, fatigued and lethargic on 02Feb2021 8-36 hrs after vaccination. The events outcome was recovered.
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| 51 | 2021-03-07 | pain in extremity | Sore right arm, foreign body sensation, mild fatigue |
| 51 | 2021-03-07 | pain in extremity |
Fever started 2 days after vaccination, followed by shortness of breath, dyspnea, weakness and pain ...
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Fever started 2 days after vaccination, followed by shortness of breath, dyspnea, weakness and pain and edema in both legs. edema was traveling up and reached umbilicus. Weakness in both legs. Started to improve with steroids. When steroids were starting to taper, symptoms worsened again. Patient was seen in ED.
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| 51 | 2021-03-07 | pain in extremity | Mild Fatigue, pain in right aram and foreign body sensation |
| 51 | 2021-03-08 | numbness |
Several hours after receiving the injection, patient developed numbness in his 4th and 5th fingers, ...
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Several hours after receiving the injection, patient developed numbness in his 4th and 5th fingers, left hand.
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| 51 | 2021-03-09 | seizure like phenomena | 3 hours post vaccine, patient passed out and lost consciousness, demonstrating seizure like activity |
| 51 | 2021-03-11 | pain in extremity |
I got my shot, 18 hours later I woke up with a mild headache and it go worse. I went into work and h...
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I got my shot, 18 hours later I woke up with a mild headache and it go worse. I went into work and had to have my wife come get me because it was so bad. It lasted 3 days. I had some arm soreness.
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| 51 | 2021-03-14 | tingling |
Warm left arm at the injection site after 4 hours. Both shoulder joints and hip joints were painful...
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Warm left arm at the injection site after 4 hours. Both shoulder joints and hip joints were painful about 8 hours after injection. Took Tylenol. Light headache and tingling under hairline on the back of the neck. 8 hours after injection. 2:30am chills until 3:00am. Fell back to sleep. 8:00 am - 9:30 am. Sore muscles and bones from head to toe. 9:45am took Motrin and Tylenol seems to work. I feel better.
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| 51 | 2021-03-16 | muscle spasms | Extreme headache, fever, nausea, leg cramps |
| 51 | 2021-03-16 | cold extremities |
1st Shot on 2/22/21, no adverse reaction aside from injection side muscle pain. 2nd Shot on 3/15/21,...
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1st Shot on 2/22/21, no adverse reaction aside from injection side muscle pain. 2nd Shot on 3/15/21, vaccine administered at 15:15EST, after going home, became very tired around 17:30, took nap, woke up at 21:30 with pounding headache and the "chills." Went to bed at that time, took ibuprofen for headache, Slept through morning alarm on TUE 3/16 at 05:15, woke up at 08:45, in to work by 10:30. Left work at 13:30 due to continued headache & body aches, chills, (had to turn a space heart on in my office), hands were cold. Took nap from 16:00 - 19:00. Still had headache, body aches, and chills. Went to bed around 21:15. Woke up on WED 3/17 at 01:30, had the chills, and was shivering, still had head ache. Turned up the thermostat from 70 to 75. Put an extra blanket on the bed. Woke up at 03:30, t-shirt and blanket soaked in sweat. Woke up for day at 05:45. Right underarm swollen, (lymph gland/nodes). Experiencing runny nose, body aches, headache continues.
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| 51 | 2021-03-17 | burning sensation, tingling |
After immunization, patient immediately felt nausea and complaint of tingling down (r) arm. Patient...
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After immunization, patient immediately felt nausea and complaint of tingling down (r) arm. Patient was very anxious, also complaint of (r) arm burning. Patient takes Gabapetin, Flexaril, ibuprofen. Patiet felt light headedness. Smoker, anxiety, hiatal hernia, chronic neck pain, history of shoulder surgery.
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| 51 | 2021-03-18 | tremor, cold sweat |
PATIENT BEGAN TO FEEL NAUSEAS, CLAMMY, AND HAD TREMORS. LASTED FOR ABOUT 30-40 MINUTES. CHECKED VITA...
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PATIENT BEGAN TO FEEL NAUSEAS, CLAMMY, AND HAD TREMORS. LASTED FOR ABOUT 30-40 MINUTES. CHECKED VITALS - SUGAR WAS 117 AND BLOOD PRESSURE 126/84. PULSE 64.
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| 51 | 2021-03-19 | flushing |
Systemic: Flushed / Sweating-Medium, Additional Details: patient became flush approximately 5 minute...
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Systemic: Flushed / Sweating-Medium, Additional Details: patient became flush approximately 5 minutes into his 15 minute observation period. Placed patient on floor and elevated legs. Patient was able to return to a sitting position in a chair approximately 8 minutes later. BP during epidose was 130/88 and pulse was 60 per automatic blood pressure cuff machine. Patient also stated he was light-headed as well. Patient was doing much better when he left the observation area.
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| 51 | 2021-03-20 | feeling hot, cold sweat |
About 10 minutes after the shot I started feeling hot, started sweating, clammy hands, dizzy and the...
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About 10 minutes after the shot I started feeling hot, started sweating, clammy hands, dizzy and then I passed out walking to get help. I hit my head on a chair when I was falling and cut my head. I stayed laying down because I was still dizzy and hot. They called the squad and did vitals and I was fine. I sat there for about another half an hour and I went home. I have felt fine ever since. Only thing that hurt was my head from the fall.
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| 51 | 2021-03-20 | tingling |
Patient first reported feeling a tingly/"prickly" feeling down his left arm and left shoulder, we ad...
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Patient first reported feeling a tingly/"prickly" feeling down his left arm and left shoulder, we advised patient to stay an extra 30 minutes for closer monitoring. About 15 minutes later his left knuckle began to swell with some redness, patient reported no difficulty breathing and no itching of the throat. Pharmacist decided to give Diphenhydramine 50mg IM after patient consented. The swelling and redness began to subside within 10 minutes. Patient received a ride home from family due to drowsiness from the Diphenhydramine
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| 51 | 2021-03-22 | numbness |
Patient was found in the bathroom , urinating , walked to the wheelchair complaining of numbness ove...
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Patient was found in the bathroom , urinating , walked to the wheelchair complaining of numbness over his whole right side denies any chest pain no tingling no trauma no incontinenc
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| 51 | 2021-03-23 | tingling |
Progress Notes 3/24/2021 Date: 3/24/2021 ...
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Progress Notes 3/24/2021 Date: 3/24/2021 Subjective Patient is a 51 y.o. male who was seen at COVID Vaccine Clinic today for his first dose of the COVID 19 vaccination. He was given the Pfizer vaccination in the right deltoid muscle. During his 15 minute waiting period after the injection, the patient began to experience "funny feeling in his face" and difficulties breathing. He denied rash, difficulty swallowing, wheezing, throat tightness, dizziness and facial swelling. This provider was notified of patient reaction and he was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to rapid progression of symptoms, respiratory distress and skin changes. ALLERGY REVIEW OF SYSTEMS: Patient denies chills, fever, facial swelling, cough, chest tightness, shortness of breath, wheezing, dizziness and headaches Previous Reactions: Denies. Objective Vitals Vitals: 03/24/21 0825 BP: (!) 132/90 Pulse: 89 SpO2: 100% Physical Exam Vitals reviewed. Constitutional: Appearance: Normal appearance. HENT: Head: Normocephalic and atraumatic. Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. No posterior oropharyngeal erythema. Comments: No swelling or lips or tongue. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing or rales. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: He is alert and oriented to person, place, and time. Assessment/Plan Treatment included: antihistamines, water and snacks Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) and Systemic reaction (hypoglycemia, hypotension, generalized rash) 3/24/2021 9:12 AM
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| 51 | 2021-03-24 | weakness |
After covid second shot I had fever i took Tylenol, fever gone. 01/08/2021 I went to work. Next morn...
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After covid second shot I had fever i took Tylenol, fever gone. 01/08/2021 I went to work. Next morning 01/09/2021 . I was stroked out taken to er. Still I have weakness on left , hearing loss, loss taste, even I drink water taste bitter. Loss smell. I am doing physical and speech therapy. Still not recovered.
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| 51 | 2021-03-24 | weakness |
The patient is a 51 yo old reservist with a history of hypercholesterolemia with an onset of illn...
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The patient is a 51 yo old reservist with a history of hypercholesterolemia with an onset of illness 10 days after Pfizer vaccine (lot #2 ELI283) on 6 JAN 2021, where he was on 87 day active duty orders with Medical Task Force - COVID mission. He denies any AE after dose #1 (Dec 17 lot #ELD140). He denies any immediate symptoms suggesting IgE event(pruritis, urticaria, SOB, wheezing, oral, facial throat, tongue swelling etc.) and denies any local site reaction. He reports about 10 days later he experienced severe nausea vomiting and diarrhea, CP and SOB. He was seen in ER 3 times where he was found to have Acute Kidney injury, and treated with IVF, odansetron meclizine dicyclimine. After the third ER visit he was admitted where he subsequently developed GI pain. He has continued to have significant health issues, but no unifying diagnosis has been identified. He would like to know if this was related to his Covid vaccine receipt. He reports no one else in his group will ill and they were otherwise isolated for travel related Covid quarantine. Per review of records he presented to ER 17 JAN 2021 (day 11) with complaints of nausea global weakness, watery diarrhea, and shortness of breath . He had a acute kidney injury with cr 1.4. A non contrast ABD CT was normal. He was diagnosed with viral gastroenteritis, treated with hydration, Zofran and Bentyl. He returned to ER 19 JAN (day 13) with a complaint of same with severe dizziness. A noncontrast head CT was normal He had a positive Dix-Hallpike and he was diagnosed with benign positional vertigo. On 1/20/21 (day 23) he continued symptoms with tachypnea on minimal exertion noted in ER. CXR demonstrated lateral RLL opacity and he was treated with Rocephin and azithromycin. He developed vague abdominal pain and was transferred to MTF. 26 JAN 21 GASTROENTEROLOGY: EGD - 'marked chronic active gastritis' - blood, stool sample and gastric biopsies are negative for H pylori infection - Protonix 40mg BID CT of kidney showed cyst on the left and nonobstructive 3mm stone and creatinine on is 0.9 (0.7-1.2).
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| 51 | 2021-03-24 | flushing |
I was given the first shot and sent to an observation room. I felt slightly flushed, it went away. B...
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I was given the first shot and sent to an observation room. I felt slightly flushed, it went away. By the evening, I started to feel flushed again. I commented to my wife that I felt like my blood pressure was up. (I don't have high blood pressure). That is the best way I can describe it. I can't recall if the ringing in my ears was noticeable at that time. My the next day I could still feel the flushed feeling and the ringing was clearly noticeable and increased over time, until it can overcome TV or someone speaking to me. I also had a feeling of persistent light headedness. About Feb 3 I had pain in my ear and went to a clinic. I was diagnosed with a minor ear infection (right). I was given and took a course of anti-biotics. The infection went away but the ringing never did, sometimes it would lessen, but always louder than prior to the shot. I went ahead and took the second shot on Feb 11, thinking my problem was probably and ear infection. I the ringing could get so loud it would wake me up and keep me awake. On Feb20 I woke up to very loud ringing, nausea, and general feeling of unease. I went to a clinic the next day. I was told there was probably some inflammation and was given a steroid shot. After about 4 hrs the ringing lessened and I felt better, the first relief I had from the start. On Feb 23, I saw my ENT Dr. He gave me a course of steroids and ordered a brain MRI. The MRI came back with negative results...no abnormal indications. The ringing is starting to increase again as of the last several days.
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| 51 | 2021-03-27 | bell's palsy |
Bell's Palsy; Arm sorness; This is a spontaneous report from a contactable consumer (wife) from a Pf...
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Bell's Palsy; Arm sorness; This is a spontaneous report from a contactable consumer (wife) from a Pfizer Sponsored Program. A 51-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number was not reported) via an unspecified route of administration, at the age of 51-year-old, administered in Arm Right on 01Mar2021 13:00 as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced arm soreness in Mar2021 (after vaccination). The patient experienced bell's palsy/experienced no mobility in the left side of the face and was diagnosed with bells palsy on 08Mar2021. The patient went to the ER in response to bell's palsy. Outcome of the events was unknown. Information about lot/batch number has been requested.
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| 51 | 2021-03-27 | night sweats, tremor |
Very Lethargic late in the night. Went to bed and had really bad chills, shakes, and ultimately nigh...
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Very Lethargic late in the night. Went to bed and had really bad chills, shakes, and ultimately night sweats. This lasted essentially through the night, into the late morning, and early afternoon. Started to fell normal late afternoon, 24-26 hours after the shot.
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| 51 | 2021-03-27 | tenderness |
Several days following 2nd dose, middle/upper back rash size of a softball, with several pimples (?)...
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Several days following 2nd dose, middle/upper back rash size of a softball, with several pimples (?) and muscle pain in that area developed suddenly. Smaller size of quarter rash with no pimples on lower edge of front right rib cage with similar pain and sensitivity. OTC tylenol and 1% hydrocortisone used. Day 5 presently since rash appeared, seems getting better although still tender but redness has subsided. Temperature normal.
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| 51 | 2021-03-28 | numbness, weakness, cold sweat, nerve pain |
chills, shivers, cold sweats, dizziness, headache, joint and nerve pain above baseline, hands and fe...
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chills, shivers, cold sweats, dizziness, headache, joint and nerve pain above baseline, hands and feet completely numb more than baseline, chest (rib cage) pain when breathing, weakness, fell several times, LOC x 1, gas, crawled instead of walked at times, bloating, abdominal cramps, diarrhea every 1-3 hours, slept the rest of the time, was able to drink Gatorade, pedialyte, water, ginger ale for hydration, no vomiting,
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| 51 | 2021-03-28 | pain in extremity, tremor, muscle spasms |
C/O dizzy, blurred vision, SOB, Right arm severe pain and tremors with Rt sided neck pain/spasms. B...
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C/O dizzy, blurred vision, SOB, Right arm severe pain and tremors with Rt sided neck pain/spasms. Brought to Medical Tent by W/C. Verbalized had a Rt sides stroke 10 years ago, hx of pain/spasms in Rt arm if irritated. Had not eaten or drank fluids. Given OJ and Gatorade. Ice applied to neck & upper arm. No redness, rash/hives at injection site. Vitals stable. Home with wife after observation of 30 minutes. Advised to f/u with primary care physician if further adverse reactions. Advised not to have vaccinations in Rt arm.
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| 51 | 2021-03-28 | pain in extremity |
Arm pain within 24 hours. However, the arm pain in my left should really start hurting on the ninth ...
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Arm pain within 24 hours. However, the arm pain in my left should really start hurting on the ninth or tenth day after the 2nd dose. By the time I made it to urgent care, I was in serious pain to the point I had to raise both of my arms to help tolerate the pain. After the EKG was done to comfirm I wasn't having a heart attack, the Nurse Practitioner ordered a pain relief injection in my right hip and a prescription of ibuprofen 800 mg along with ice compression on my left arm where I received the 2nd dose.
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| 51 | 2021-03-28 | tingling |
Developed paresthesias in right arm, into axilla, nex and right side of face; burning irritation of ...
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Developed paresthesias in right arm, into axilla, nex and right side of face; burning irritation of right eye; This is a spontaneous report from a contactable nurse (the patient). A 51-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: EL0142), via an unspecified route of administration, in the right arm on 29Dec2020 at 15:00 PM (at the age of 51 years) as a single dose for COVID-19 immunization. Medical history included sciatica. There was no known allergies. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Dec2020, within 4 hours of vaccination, the patient developed paresthesia's in right arm, into axilla, neck and right side of face, burning irritation of right eye. The patient was evaluated by neurologist. No treatment given. Symptoms resolved in 10 days. The clinical outcome of the events paresthesia's in right arm, into axilla, neck and right side of face, burning irritation of right eye was recovered on 08Jan2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified.
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| 51 | 2021-03-29 | burning sensation, tingling, numbness, feeling cold |
Shortly after receiving the injection my arm went ice cold all the way to my fingers and warmed up a...
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Shortly after receiving the injection my arm went ice cold all the way to my fingers and warmed up again quickly. On the way home (about an hour later) I noticed numbness and tingling in my hand and that has continued since (11 days as of this report). My upper arm muscle was sore later that evening and by the next day the pain in my upper arm was extreme. I couldn't move my arm without extreme pain. I took some tylenol late in the day and that did help cut down on some of the pain. I also put an ice pack on my upper arm but it didn't help. The pain wasn't as bad the next (3rd) day but it's still significant enough for me to restrict activity with it. There is also a burning sensation off and on as well as itching deep in my arm. My upper arm has also felt like there is a tight band around it (since day 2) although the muscles themselves don't feel like there's any tightness or knots. I took ibuprofen on day 10 and it helped a little but not a whole lot. At this point I also have what feels like swelling or tenderness under my arm near the armpit area. The pain, burning and itching in my upper arm continues as well as the numbness, tingling and pins all up and down my arm to my hand and fingers.
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| 51 | 2021-03-29 | feeling hot |
Per pt c/o intermittent feeling of feeling hot lasted 5 minutes and lasted for 2 days. Only occurred...
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Per pt c/o intermittent feeling of feeling hot lasted 5 minutes and lasted for 2 days. Only occurred 2 times. 1 episode 3/10/21 the other episode 3/11/21 then subsided.
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| 51 | 2021-03-29 | muscle twitching |
2.8kg 51 yo M with hx of hypothyroidism and allergy to pencillin was given his first Pfizer vaccine ...
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2.8kg 51 yo M with hx of hypothyroidism and allergy to pencillin was given his first Pfizer vaccine around 0915 3/27 at Medical Center (lot # not reported). Within 5 minutes he states he felt a "jolt" throughout his body and became very nervous and had sweaty hands. Patient reported symptoms at the vaccination location. Blood pressure was reportedly "low" and patient was told he could leave if he felt better. After about 30 minutes from the injection, patient decided to go home but continued to feel nervous and was twitching all over and decided to come to urgent care. He presents with chest pressure (4/10), muscle tremors, mouth dryness and mild dizziness. Denied any history of Covid.Denied any previous reactions to any vaccines. Denied any shortness of breath/trouble breathing, lightheadedness, nausea, or vomiting. No history of high blood pressure or high cholesterol. Denies any history of anxiety or nervousness. States he felt fine prior to the vaccine. Patient did drink his coffee and have a flour tortilla along with a breakfast bar today. HR 82 but BP elevated 199/122.at 1125. BP treated with SL nitroglycerin and four 81mg aspirin. Chest pain improved 1/10. EKG showed inverted T waves V4-V6 with no ST elevation or depression. Sent to ED where EKG was repeated. Incomplete right BBB. BP 128/73 and pulse 47. CXR negative. Unknown if patient was admitted. ED was at Medical Center.
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| 51 | 2021-03-29 | pain in extremity | Soreness in arm, aches, vomiting (though this could have been from food poisoning, we are not sure) |
| 51 | 2021-03-30 | feeling cold | Pain at injection site; fatigue; headache; chills |
| 51 | 2021-03-30 | numbness, tingling |
I had a tingling/numbness feeling in my face similar to Novacaine. It was only in the areas of my f...
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I had a tingling/numbness feeling in my face similar to Novacaine. It was only in the areas of my face where my beard and mustache were. It dissipated in about 30 minutes. Then I had chills at about 1.5 hours.
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| 51 | 2021-03-30 | pain in extremity |
Sore arm; Diarrhea; This is a spontaneous report from a contactable consumer or other non hcp (patie...
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Sore arm; Diarrhea; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 51-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN5318, batch and expiration date not reported), via an unspecified route of administration, administered on the left arm on 26Jan2021 07:00 (at the age of 51-years-old) at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered to the patient was at the Workplace Clinic. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient experienced sore arm and diarrhea on 26Jan2021. Events were assessed as non-serious. Treatment was not received for the events. The outcome of the events reported was unknown.
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| 51 | 2021-03-31 | difficulty speaking | Developed hoarseness and then loss of voice. |
| 51 | 2021-03-31 | pain in extremity |
Dehydration; Pain in kidney area; Soreness in left arm; Costochondritis flare up; This is a spontane...
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Dehydration; Pain in kidney area; Soreness in left arm; Costochondritis flare up; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN6206), via an unspecified route of administration administered in left arm on 06Mar2021 at 10:30 AM as SINGLE DOSE for COVID-19 immunisation. The patient had no other vaccine in four weeks. The patient had no COVID prior vaccination and was not COVID tested post vaccination. Medical history included heart attack 3 years prior and a prior kidney stone event. The patient had no known allergies. Concomitant medication included atorvastatin. On 06Mar2021 at 12:30 PM, the patient experienced soreness in left arm starting about 2 hours after administration of the vaccine. On 06Mar2021 at 18:30, the patient experienced dehydration and pain in kidney area on left side starting about 8 hours after vaccination, lasting through the next day. Felt similar (though not as intense) to a prior kidney stone event, but slightly higher and in front left side. Costochondritis flare up overnight after the vaccine on 06Mar2021. There was no treatment given for the events. The patient was recovering from all events.
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| 51 | 2021-04-01 | bell's palsy |
Myasthenia gravis; double vision, cannot focus; left eye droop/right eye droop; Bell's Palsy came ba...
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Myasthenia gravis; double vision, cannot focus; left eye droop/right eye droop; Bell's Palsy came back with left eye droop/right eye droop; Bell's Palsy came back with left eye droop/right eye droop; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received the first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE), via an unspecified route of administration in the left arm on 09Mar2021 08:48 am (lot number: EN6199) as a single dose for covid-19 immunisation. Medical history included facial paralysis from 20Jan2021 to an unknown date diagnosed initially as bell's palsy but now is diagnosed as myasthenia gravis and gastric reflux. Concomitant medication included unspecified gastric reflux medication and unspecified vitamins. The patient did not receive other vaccines within 4 weeks prior and did not receive other vaccine on the same day. The patient previously he was put on prednisone 60 mg tablets by mouth times 7 days, then 10 mg tablets for an additional 7 days. The patient mentioned he received the vaccine in a vaccination center. The patient reported that prior to his first shot towards the end of Jan2021, his doctor thought he had Bell's Palsy. On 20Jan2021, he stated that he was put on a high dose of steroids to clear it up. He stated that on 09Mar2021, he had his first Covid vaccine with no issues. On 12Mar2021 between 5-6 pm, he mentioned that it came back (the Bell's Palsy) with a vengeance, near his eye and with eye droop. He specifies left eye droop. He added that the Monday after (15Mar2021) over the weekend, it got worse. He mentioned that he talked with his neurologist who told him to speak with his ophthalmologist who the patient spoke to on Tuesday. The patient mentioned that both doctors came up with the diagnosis of Myasthenia Gravis. He inquired since one of his doctor's is concerned about him taking the second vaccine and the other doctor was ok with it. He mentioned that one doctor had a feeling of some bias, and the other doctor. He did some research in an association with people diagnosed with it. One of his doctors said that he is immunocompromised, so he looked at autoimmune information, and the information says it is ok. He reached out to the local medical center that is doing the vaccination and they are unwilling to talk with him over the phone. He has read on the association site and they seem to recommend to take it. He did not want to rebel against his doctor, so he wants to be sure. He inquired if it was safe for him to take his second dose and wanted to get good factual information that can give him a good starting point that is related. He mentioned that his second dose schedule was on 30Mar2021. He also stated that initial onset of Bell's Palsy with left eye droop, he was on a high dose steroid regimen and that seem to help which he finished up early Feb2021. It was mentioned that the event initial onset was not after the vaccine. The Ophthalmologist checked him on Tuesday and his left eye which he could barely open, and his doctor also noticed right eye droop. He stated without medication, it is worsening but with his medication, it is definitely helping to transmit between nerves. He stated before the medication this time of day he could not lift his left eye longer throughout the day, the more difficult it is for the muscles as they become weaker. There was noticeably drooping of the right eye. The ophthalmologist exam on his right eye was drooping which was ongoing. It is still there, his wife and he were comparing their eyes and how much he could open it, and it surprised them how little he could open it. It was different and strange. The time reported for the drooping of the right eye was 2:30 pm and persisting but the left eye was worse. He hasn't noticed a difference about the same, medication has been helping. It was also mentioned that myasthenia gravis reported that it started on the 16Mar2021 2:30 pm (talked to the Neurologist to compare notes, so maybe 3:30 - 4:00) when they made the initial diagnosis and started testing the next day. He is waiting for blood work to come back, but all the tests have pointed in that direction. Myasthenia gravis was ongoing, but the condition has worsened and the medications at a therapeutic level, it keeps it at bay. He further added that his eye became so hard to see, so he pyridostigmine bromide on 17Mar2021 since he couldn't open or focus, he thought he would give it a try. It works when he can't focus and if he doesn't take, it he will go back to where he was before. He will not be able to open his eye and the double vision will come back. The events required physician's office visit but did not require emergency room visit. He mentioned that there were 3 test and one more scheduled. The first one was a common test; the first initial test diagnose Myasthenia gravis. The second test was the ice test since they went on the assumption in their initial thinking it was Bell's Palsy and in his, doctor's, opinion it didn't look right. The test sounds goofy and it is one of the tests, they did to predict how it was going to go. He reported that they placed an ice cube in a cloth on the eye and let cool for 2-3 minutes. The eye lid is raised more than it was before the test and it went back down. This test was done on 16Mar2021. He reported that the did a chest x-ray on 17Mar2021 and looked for enlarge thalamus, he states it was normal. He has a CT scheduled next Wednesday (24Mar2021) to check his thalamus and lungs. The patient underwent lab tests and procedures which included blood test with unknown results on 17Mar2021, he reported that he is waiting for the results to look for antibodies for Myasthenia gravis; chest x-ray was normal on 17Mar2021, he reported that they did a chest x-ray and looked for enlarge thalamus, he states it was normal; endoscopy with results of no finding on Mar2021, his GI doctor wanted to do an upper and lower endoscopy, so 2 weeks prior to the vaccine he had an upper and lower endoscopy with no finding; and ice test with results of bell's palsy on 16Mar2021 and in his doctor's opinion, it didn't look right. The outcome of the events was not recovered.
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| 51 | 2021-04-01 | feeling cold |
Ringing in ears head cold feel. Throbbing and slight pain in ear. Mainly left ear. Have contacted ...
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Ringing in ears head cold feel. Throbbing and slight pain in ear. Mainly left ear. Have contacted nurse and tele doctor and I am taking antibiotics now. About 4 days now.
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| 51 | 2021-04-01 | numbness |
About 3-4 days after the shot I was walking in food city and my left foot felt like it was asleep li...
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About 3-4 days after the shot I was walking in food city and my left foot felt like it was asleep like it wouldn?t wake up later that day it kept getting stiffer and stiffer and eventually went all the way up the whole left side of my body went kind of numb it The next day I woke up it was completely stiff hard to walk so I went to my doctor he thought it was something to do with the spinal cord I told him it could possibly be from the shot I thought maybe went through many thousands of dollars of tests they tested me for MRIs I?ll kinds of stuff they have yet to find anything wrong with me I?ve been in and out of the doctors I still have left sided numbness at times left side of my head feels numb left chest left but area and all way down to my toes At this point after going to the neurologist only thing they?re all just could find was I was low on vitamin B 12 I have started injections on vitamin B 12 I still have no notice no change
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| 51 | 2021-04-01 | night sweats |
Unusual impotence; Extreme night sweats; Elevated heart rate resting rate of 100. My normal is 74 BP...
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Unusual impotence; Extreme night sweats; Elevated heart rate resting rate of 100. My normal is 74 BPM; Shortness of breath; This is a spontaneous report from a contactable other health care professional. A 51-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 intramuscular, administered in Arm Left on 02Mar2021 16:00 (at the age of 51-years-old) (Batch/Lot Number: EN6201; Expiration Date: 30Jun2021) as SINGLE DOSE for covid-19 immunisation. The patient's medical history was reported as none. The patient's concomitant medications were not reported. The patient previously took tylenol and experienced allergies. The patient did not receive other vaccines in four weeks, and other medications in two weeks. On 12Mar2021 16:00, the patient experienced Elevated heart rate resting rate of 100. My normal is 74 BPM. Shortness of breath. Extreme night sweats. Unusual impotence. All started 10 day after injection. The outcome of the events was not recovered.; Sender's Comments: The company does not attribute the unusual impotence (PT: Erectile dysfunction) to BNT162b2, considering the event being an intercurrent disorder. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 51 | 2021-04-01 | pain in extremity |
Sore arm for two days, mild general fatigue, but at -37 hours post-vaccine, upper lip itched and sw...
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Sore arm for two days, mild general fatigue, but at -37 hours post-vaccine, upper lip itched and swelled slightly. Went down after taking a Benadryl.
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| 51 | 2021-04-01 | pain in extremity |
Pain in left arm. Fever (102.7). Chills. Fatigue. Headache. Dizziness. Light-headedness. ... All las...
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Pain in left arm. Fever (102.7). Chills. Fatigue. Headache. Dizziness. Light-headedness. ... All lasting at least 15 hours. Cleared upby the next morning.
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| 51 | 2021-04-01 | pain in extremity |
has a constant severe headache; tinnitus in right ear/Tinnitus continues to persist/Right Ear ringin...
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has a constant severe headache; tinnitus in right ear/Tinnitus continues to persist/Right Ear ringing; stomach pain; high BP; sore arm; tinging in in throat and right side of face,; irritated right eye; Right Ear ringing worsened culminated in 8 days of insomnia from severe ringing; mesenteric inflammation; This is a spontaneous report from a contactable nurse (patient) and a consumer. A 51-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in arm left on 29Jan2021 (Batch/Lot Number: EL3247) at single dose for COVID-19 immunization. Medical history included sciatica (resolved), and the patient took the first dose of BNT162B2 (lot/batch number: EL0142) at 15:00 on 29Dec2020 administered in arm right for COVID-19 immunization and developed paresthesias in right arm, into axilla, nex and right side of face and burning irritation of right eye, both on 24Jan2021. The patient's concomitant medications were not reported. Clinical course: 3 days after vaccination, patient developed sore arm, tinging in in throat and right side of face, irritated right eye. 6 days after vaccination, patient woke up with tinnitus in right ear, stomach pain and high BP. On 30Jan2021 (as reported), patient went to Emergency Room. CT scan showed mesenteric inflammation. Right Ear ringing worsened which culminated in 8 days of insomnia from severe ringing. Tinnitus continues to persist. He also had a constant severe headache. All events were reported as serious and seriousness criteria were disability. No allergies to medications, food, or other products. The adverse event result in Doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was not recovered.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the events cannot be completely excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees. and investigators, as appropriate.
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| 51 | 2021-04-02 | feeling cold, tremor, pain in extremity, cold sweat |
after 4 hours - sore arm - this was expected. After 10 hours - body cold - skin dry - severe shaking...
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after 4 hours - sore arm - this was expected. After 10 hours - body cold - skin dry - severe shaking / teeth chattering - uncontrollable - then sweating / cycle hot & cold. Cannot stop shaking. Severe lower body aches - from hips down - bones aches. After 30 hours - fever of 102.1 for around 2 hours. seems like a sever flu. After 48 hours - feeling much better - low fever - 100 all day Friday April 2nd. Good nights sleep - feel great Saturday April 3rd - temp at 99.
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| 51 | 2021-04-02 | tremor |
Severe pain in shoulder, to where I could not lift arm, Felt like 20 hornets stung me, 100.4 tempera...
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Severe pain in shoulder, to where I could not lift arm, Felt like 20 hornets stung me, 100.4 temperature, fatigue, and had the shakes. This was from Wednesday night through Thursday. Felt better on Friday.
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| 51 | 2021-04-04 | tenderness |
The morning after his vaccination, his left elbow swelled up and was tender. The elbow gradually de...
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The morning after his vaccination, his left elbow swelled up and was tender. The elbow gradually decreased in size. Patient wants to get his next dose in his right arm.
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| 51 | 2021-04-05 | pain in extremity |
About 4 hours after the shot (on Monday), I developed pain in my left leg--particularly the left but...
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About 4 hours after the shot (on Monday), I developed pain in my left leg--particularly the left buttock and left shin. The pain rapidly became worse. Walking became quite difficult. Tuesday, I received a steroid injection from my doctor. The pain got slightly better over the next few days. Saturday, I started a course of oral steroids: 20mg prednisone, three times per day. Symptoms have been improving significantly, although as of today (Tuesday) there is still some pain. The pain was specific to my leg. I didn't get any other aches.
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| 51 | 2021-04-06 | feeling hot |
pt c/o feeling hot. Denies SOB pain, itch or diziness. appears diaphoretic. said he feels anxiety. ...
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pt c/o feeling hot. Denies SOB pain, itch or diziness. appears diaphoretic. said he feels anxiety. Used interpreter. 140/92 HR 128 O2 sat 97 BS 196
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| 51 | 2021-04-06 | numbness, numbness and pain in extremities, tingling |
General muscle soreness 2 days after vaccine, then peripheral neuropathy started day 3 after vaccine...
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General muscle soreness 2 days after vaccine, then peripheral neuropathy started day 3 after vaccine. Signs progressed to dizziness, numbness of feet and hands, prickly sensations over arms and legs. Unable to resume normal daily functions. Symptoms still present as of today
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| 51 | 2021-04-06 | pain in extremity |
Sore arm that developed into very painful area on left side of ribs as well, fever for 3 days up to ...
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Sore arm that developed into very painful area on left side of ribs as well, fever for 3 days up to 101 degrees
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| 51 | 2021-04-06 | pain in extremity |
patient stated his arm swelled and hurt the next day. His lips swelled but he could not take Benadry...
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patient stated his arm swelled and hurt the next day. His lips swelled but he could not take Benadryl. He took a Claritin instead
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| 51 | 2021-04-07 | weakness |
First symptom was weakness and fatigue approximately 8 hours after injection. Onset of fever of 101...
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First symptom was weakness and fatigue approximately 8 hours after injection. Onset of fever of 101? F approximately 12 hours after injection, 24 hours after onset still had 100? F temperature, gone by beginning of day 3. Headache and body aches that lasted about 3 days. After fever was gone the weakness/fatigue/headache/body aches lasted an additional 12 hours or so. Approximately a day after all these symptoms disappeared I got a very minor sore throat and some congestion that has lasted a couple of days. Treatment was Alleve every 8 hrs, lots of fluids and rest.
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| 51 | 2021-04-07 | bell's palsy, facial paralysis |
pt states on 4/1/2021 when he woke up his mouth was crooked and face was dropping. He thought he wa...
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pt states on 4/1/2021 when he woke up his mouth was crooked and face was dropping. He thought he was having a stroke Pt went to Hospital ER. They gave him a CT, Blood test, X-RAYS. pt was transported to another hospital to have the MRI which showed no sign of stroke. He was brought back to hospital where he was admitted for observation. He was released after 3 days. His DX was Bells Palsy. He was prescribed valacyclovir 1mg bds and prednisone. He has to wear a patch of his left since he cant close it and he has no control of the tear ducts in this eye. The left side of this face is still drooping and he cant use the left side of his mouth and he bites his tongue when he is eating. He wishes he had not taken the shot.
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| 51 | 2021-04-08 | numbness | Sensation of numbness/tingling washing over B arms and legs and nose |
| 51 | 2021-04-10 | pain in extremity |
I had the usual sore arm, fatigue, and body aches. But the one side effect I had was insomnia for tw...
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I had the usual sore arm, fatigue, and body aches. But the one side effect I had was insomnia for two days. I missed work the day after receiving the shot (Wednesday). Went to work on Thursday with no sleep. Missed on Friday due to not being able to sleep.
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| 51 | 2021-04-11 | weakness |
From 4pm Saturday including all day Sunday I had fever and chills, low energy, and headache. I alter...
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From 4pm Saturday including all day Sunday I had fever and chills, low energy, and headache. I alternated between Tylenol and Advil to treat fever symptoms.
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| 51 | 2021-04-11 | pain in extremity |
SORE ARM, EXHAUSTED ON SATURDAY. SUNDAY MORNING TEMP OF 102, NAUSEA, CHILLS, JOINT PAIN ITCHING LEFT...
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SORE ARM, EXHAUSTED ON SATURDAY. SUNDAY MORNING TEMP OF 102, NAUSEA, CHILLS, JOINT PAIN ITCHING LEFT NECK AND LEFT FACE FAST HEART RATE (102 AT REST NORMAL IS 60 AT REST) CONTINUED TO MONDAY MORNING.
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| 51 | 2021-04-11 | pain in extremity |
approximately 2-3 hours after injection, unusual discomfort in the front left pelvic area. 8.5 hours...
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approximately 2-3 hours after injection, unusual discomfort in the front left pelvic area. 8.5 hours after injection, left ear ringing and arm left deltoid soreness began. Woke up in the middle of the night with dizzyness. The next morning, dizzyness has subsided, left arm soreness and left ear ringing continues. Took 2x200mg ibuprofen.
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| 51 | 2021-04-11 | tremor, pain in extremity |
It started feeling current in the posterior part of the body, then it started pain in the whole body...
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It started feeling current in the posterior part of the body, then it started pain in the whole body that continued to increase and burning sensation in the skin, chills, felt like was burning, marked respiratory difficulty, sensation of asphyxia, pain in the ribs, urinary retention, hematuria, liquid diarrheas, trembles, pain in the ribs and pain in the left arm (contrary to the one injected). Took Tylenol 500 mg 2 tabs q 4 hrs
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| 51 | 2021-04-14 | bell's palsy |
Bells palsy diagnosis. Given Prednisone. Started to recover then received second dose on 04/06/2021 ...
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Bells palsy diagnosis. Given Prednisone. Started to recover then received second dose on 04/06/2021 and symptoms of bells palsy returned to level prior to medication.
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| 51 | 2021-04-14 | facial paralysis, bell's palsy |
DEVELOPED BELL?S PALSY - DIAGNOSED 4/14/2021 COLD SYMPTOMS DEVELOPED 8 DAYS AFTER SECOND SHOT (4/3/...
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DEVELOPED BELL?S PALSY - DIAGNOSED 4/14/2021 COLD SYMPTOMS DEVELOPED 8 DAYS AFTER SECOND SHOT (4/3//2021), AND THEN FACIAL PARALYSIS WITH BELL?S DIAGNOSED ON 4/14
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| 51 | 2021-04-14 | pain in extremity |
Arm hurt for 3 days, nausea and stomach/intestinal cramping started 24 hours later, vomited once /2...
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Arm hurt for 3 days, nausea and stomach/intestinal cramping started 24 hours later, vomited once /24 hours after vaccine and spent the rest of the day in bed. Felt better 48 hours after vaccine.
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| 51 | 2021-04-14 | tremor | fever and chills with severe shaking that lasted for about three hours |
| 51 | 2021-04-15 | slurring |
Cryptogenic stroke. Experienced garbled speech for a period of less than one minute. Symptoms resolv...
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Cryptogenic stroke. Experienced garbled speech for a period of less than one minute. Symptoms resolved on their own. Went to ER and had an MRI showing three spots for affected tissue.
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| 51 | 2021-04-15 | muscle twitching |
The day after my vaccination I felt like I had mild to moderate flu symptoms, achy, stuffy with head...
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The day after my vaccination I felt like I had mild to moderate flu symptoms, achy, stuffy with headache. The day after that the flu like symptoms abated, but then were replaced with muscular and joint soreness, especially in the lower legs. It felt like my calf muscles were going to charlie horse at any moment. Also, I experienced random muscle twitches throughout my body, but mostly in the calf region. This muscular twitching has continued for two weeks now, though it has abated to some degree in terms of frequency and intensity. The muscle twitching is the reason that I'm writing this report. I expected that I might have flu like symptoms, but not twitching muscles all day and night.
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| 51 | 2021-04-16 | bell's palsy | Bell?s palsy- prednisone and anti-viral drugs |
| 51 | 2021-04-17 | bell's palsy |
Left facial Bell's Palsy; BNT162B2 subcutaneous; This is spontaneous case report from a contactable ...
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Left facial Bell's Palsy; BNT162B2 subcutaneous; This is spontaneous case report from a contactable physician (patient himself). A 51-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL1283), subcutaneous, at Arm Left on 09Jan2021 (at age of 51 years old) at single dose for COVID-19 immunisation. Medical history was none. The patient's concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EH9899) Subcutaneous at Left Arm on 18Dec2020 18:00 (at 51 years old) at single dose for COVID-19 immunisation. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. Test Name: SARS-CoV2 RT PCR. Allergies to medications, food, or other products was None. The patient experienced Left facial Bell's Palsy on 30Jan2021. The patient underwent lab tests and procedures which included Nasal Swab: negative on 31Jan2021. The adverse event Left facial Bell's Palsy result in Emergency room/department or urgent care. Treatment (Prednisone, Acyclovir) received for the adverse event. The outcome of the events was unknown.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported event of Left facial Bell's Palsydue to temporal relationship and current known drug safety profile. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 51 | 2021-04-18 | weakness |
Fatigue, weakness, achiness- especially in legs Now is in the hospital due to severe optic nerve sw...
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Fatigue, weakness, achiness- especially in legs Now is in the hospital due to severe optic nerve swelling behind both eyes
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| 51 | 2021-04-18 | pain in extremity, tingling, numbness |
Tingling and numbness in both arms and hands, but mainly in the left arm. The tingling and numbness...
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Tingling and numbness in both arms and hands, but mainly in the left arm. The tingling and numbness began about a day after the shot and I thought at first that it had to do with yardwork, but it has continued for about nine days so far. It goes away for a few hours a day and some nights are not as bad as others, but it's painful - like your hand/arm falling asleep for an extended period of time - and interferes with sleep as well as concentration during the day.
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| 51 | 2021-04-18 | pain in extremity |
Blood Clot/The Blood clot was in the legs and went to his lungs; Blood Clot/The Blood clot was in th...
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Blood Clot/The Blood clot was in the legs and went to his lungs; Blood Clot/The Blood clot was in the legs and went to his lungs; fell; Leg pain; This is a spontaneous report from a contactable consumer. A 51-year-old male patient received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 27Mar2021 (Batch/Lot Number: EP6955) as single dose for covid-19 immunisation. Medical history included thrombosis from 2020 to an unknown date, it was Months ago in 2020, He was prescribed a medicine for blood clots, but since then he has had no issues, anxiety from an unknown date and unknown if ongoing. Her brother in law had anxiety about even getting the vaccine. The patient experienced leg pain on Mar2021 , pulmonary thrombosis, leg thrombosis and fall on an unspecified date. The patient died on 02Apr2021. An autopsy was not performed. The clinical course was the following: The Blood clot was in the legs and went to his lungs, his leg never got red or anything and it was a blood clot. He was having such bad leg pain, it's too bad, had there been some sort of warning, he would have thought to wait till next year. There was nothing the day he got vaccine, but that night his leg started hurting, his girlfriend said let me go get a cold wrap and she wrapped it, he's a farmer. He wakes up the next day and his leg is still hurting, the 3rd day it goes on, his leg still hurting and no one is thinking it a blood clot, he calls the doctor and tells the doctor his leg is hurting, they suggest ibuprofen for inflammation, the next day thought maybe it's better, by Friday he was making breakfast, fell and died. With his girlfriend she said what's going on, and he went straight to hospital, they said the clot in his leg went to the lung. The Blood clot when it was in the leg it never got hot, red, or anything like that. He had the vaccine in the morning and on that same day the leg pain started later that night. It Started out with Leg Pain, she does not know if it was right or left but it was just one leg.; Reported Cause(s) of Death: Thrombosis pulmonary; Thrombosis leg; Fall; Leg pain
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| 51 | 2021-04-19 | feeling cold |
Ringing in both ears. Both ears feel clogged. Hard to hear. Vertigo Chills and aches (which I ex...
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Ringing in both ears. Both ears feel clogged. Hard to hear. Vertigo Chills and aches (which I expected)
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| 51 | 2021-04-19 | pain in extremity |
sore left arm, for 36 hours post shot. joint pain 12 hours post shot approximately 9 days later, br...
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sore left arm, for 36 hours post shot. joint pain 12 hours post shot approximately 9 days later, broke out in Hives, abdominal cramps, constipation. lasted approx 4 days. no changes in diet
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| 51 | 2021-04-20 | weakness |
Severe muscle pain and weakness in entire body, crippling-unable to walk or even stand with the assi...
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Severe muscle pain and weakness in entire body, crippling-unable to walk or even stand with the assistance of a walker device. lasted 3 days - Same side effect as after 1st dose.
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| 51 | 2021-04-20 | weakness |
Severe muscle pain and weakness in entire body, crippling-unable to walk or even stand with the assi...
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Severe muscle pain and weakness in entire body, crippling-unable to walk or even stand with the assistance of a walker device. lasted 3 days
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| 51 | 2021-04-20 | pain in extremity |
Really sore arm all the way to my hand, around my neck and shoulder where the shot was given. Tired...
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Really sore arm all the way to my hand, around my neck and shoulder where the shot was given. Tired and fatigued really bad. Barely get moving every day since shot.
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| 51 | 2021-04-20 | pain in extremity |
Become so forgetful since I had the injection that it feels like I have Alzheimer's; brain fog; Brai...
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Become so forgetful since I had the injection that it feels like I have Alzheimer's; brain fog; Brain fog and fatigue is unreal/fatigue; chilling pain; it feels like I have Alzheimer's; Arm is till really hurting; Hematoma; This is a spontaneous report from a contactable consumer. A 51-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, in Arm Left on 28Mar2021 (Batch/Lot Number: EP6955) as single dose for covid-19 immunisation. Medical history included ongoing hypertension, anxiety, blood cholesterol increased, hypertriglyceridaemia, covid-19 from Sep2020 ("My wife was tested positive, I had it back in September, my wife was tested positive in January and that's when I started experiencing loss of smell and taste). Concomitant medications included lisinopril taken for hypertension, propranolol taken for hypertension, alprazolam (XANAX) taken for anxiety, atorvastatin calcium (LIPITOR) taken for blood cholesterol abnormal, bacopa monnieri, eleutherococcus senticosus root, rosmarinus officinalis essential oil, schisandra chinensis fruit (BACOPA COMPLEX) taken for hypertriglyceridaemia. On unknown date patient experienced "become so forgetful since i had the injection that it feels like I have Alzheimer's", fatigue, brain fog, chilling pain and on 01Apr2021, arm is till really hurting and hematoma (described as I went to ER last night and he said that the pharmacist might have punctured a vain or a capillary). Patient had no temperature, blood pressure is normal, patient stated he never had anything like that from other vaccines.
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| 51 | 2021-04-20 | tremor | Severe body aches. Pain in the injection site. Extreme body shakes. Headaches and back pains. |
| 51 | 2021-04-21 | burning sensation |
diarrhea. one the day after vaccine Stomach gurgling when eating or drinking day 2...worse when lyin...
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diarrhea. one the day after vaccine Stomach gurgling when eating or drinking day 2...worse when lying down Day 4 upper Stomach discomfort/Pain minor Day 5 increased pain burning sensation Day 14 still persistent
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| 51 | 2021-04-21 | cold sweat |
i experienced cold sweats and an unwell feeling shortly after injection. I passed out at the vaccina...
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i experienced cold sweats and an unwell feeling shortly after injection. I passed out at the vaccination site and was taken by ambulance to the medical center yesterday, april 21st around 356pm.
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| 51 | 2021-04-21 | pain in extremity | Severe fatigue. Arm soreness. Light nausea. Flu-like symptoms |
| 51 | 2021-04-22 | pain in extremity |
102 degree F Fever - 4 hours reduced with Advil Mild 99 - 100 degree F fever for 1.5 days, reduced w...
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102 degree F Fever - 4 hours reduced with Advil Mild 99 - 100 degree F fever for 1.5 days, reduced with Advil Severe headache for 4 hours followed by mild headache for 3 days reduced with Advil Sore achy muscles in arms and legs - 2 days Sore joints, knees, elbows shoulders - 2 days Tired and lethargic for 2 days.
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| 51 | 2021-04-24 | muscle spasms |
Patient had first dose on 4/1/21 he developed fatigue and muscle cramps lasting about 36 hours Pati...
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Patient had first dose on 4/1/21 he developed fatigue and muscle cramps lasting about 36 hours Patient had second dose 4/22/21 and once again developed muscle cramps. He also started to have vision changes, increase thirst, and blood sugar spikes between 400-500. He is not a diabetic
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| 51 | 2021-04-25 | weakness, numbness, feeling hot |
patient having reaction to pfizer shot given on april 11th. patient states symptoms from numbness to...
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patient having reaction to pfizer shot given on april 11th. patient states symptoms from numbness to extremities, shortness of breath, sores on lip, headache, yellow eyes, weakness. on 4/25 Overnight he felt very "hot", like he was breaking a fever, but was not febrile per vital signs. He sweated and then noticed bubbling of his skin on both hands and feet and then those bubbles popped and his skin is peeling now.
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| 51 | 2021-04-25 | migraine, cold sweat |
Migraine headache that persisted the entire day. Took a Bayer Back & Body Extra Strength (500mg) to ...
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Migraine headache that persisted the entire day. Took a Bayer Back & Body Extra Strength (500mg) to attempt to get rid of itarround noon. Headache only lessened slightly but persisted. Cold chills began in the late afternoon and persisted into the evening. No fever was detected when checked. Took a second Bayer Back & Body Extra Strength around 8pm before bed. Fell asleep about 10pm. Woke up with alarm at 2am. Clothes had a feeling of having absorbed a cold sweet while asleep. Cold chills no longer present, migraine headache no longer present.
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| 51 | 2021-04-25 | migraine |
syncope, followed by profuse sweating, patient fainted twice., very low blood pressure, severe migr...
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syncope, followed by profuse sweating, patient fainted twice., very low blood pressure, severe migraine and vomiting EMS called after prolong time of syncope and vomiting. Patient refused travel to ER. I followed up a call to the patient later in the day and patient was tired but had fully recovered.
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| 51 | 2021-04-25 | muscle spasms, weakness, pain in extremity, cold extremities |
Extreme joint pain tiredness fingers felt cold and ached to touch anything sore neck in lymphnode ar...
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Extreme joint pain tiredness fingers felt cold and ached to touch anything sore neck in lymphnode area then the headaches started a few days later like 5 days i felt very tired weak not sick to stomach but felt like blood was dirty hard to explain right kidney hurt then weeks of headaches felt like head was bleeding it hurt so bad chest felt like just got over a chest cold or bronchitis or ran out in cold weather and also very cramped feet some of this still happening but most has subsided . The scariest part was the feeling of my headache terrible .i never went to a er or doctor but almost did.
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| 51 | 2021-04-25 | pain in extremity | Left are was painful and stiff for 2-4 days. |
| 51 | 2021-04-26 | tingling |
Client received vaccine and began to feel a tingling sensation on his left hand and believed it look...
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Client received vaccine and began to feel a tingling sensation on his left hand and believed it looked blue. Assessed client. Vitals all wnl. no further evaluation needed. Client released at 1:15pm.
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| 51 | 2021-04-26 | unresponsive to stimuli |
Systemic: Fainting / Unresponsive-Mild, Additional Details: nurse instructed pt to call for ride hom...
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Systemic: Fainting / Unresponsive-Mild, Additional Details: nurse instructed pt to call for ride home pt declined and said he did not feel the need. he hais he feel better and pt discharged
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| 51 | 2021-04-27 | flushing |
Reports after the vaccine his arm has become swollen and hard. It will go away, but then it comes ba...
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Reports after the vaccine his arm has become swollen and hard. It will go away, but then it comes back. Today in office it was indurated slightly. Reports on and off flushing and body aches that are new- feels like a toothache
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| 51 | 2021-04-27 | tremor |
Swollen glands in neck at collarbone, arm pit and groin area upon awaking on day three. All swollen...
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Swollen glands in neck at collarbone, arm pit and groin area upon awaking on day three. All swollen glands were on the side the injection was given, and are visible to the naked eye. Physician advise taking Benadryl and consult them in 24 hours if effects continue. First dose side effects were shaking, rapid heart rate, and lethargic, lasting 2 weeks. These side effects were not present with second vaccine at this time.
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| 51 | 2021-04-28 | muscle twitching | Frequent facial twitching and on less frequently on the arm |
| 51 | 2021-04-28 | cold extremities, pain in extremity |
he reports discoloration resolved but developed worsening bilateral lower extremity edema; lower ext...
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he reports discoloration resolved but developed worsening bilateral lower extremity edema; lower extremity pain and swelling; lower extremity pain and swelling; blue toes on both feet; extensive deep vein thrombosis in left lower extremity requiring treatment and thrombectomy; legs were cool to touch; This is a spontaneous report from a contactable physician reporting for a patient. A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular on 02Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation, at 51 years old. Medical history included triplegia, neurogenic bladder, hyperlipidaemia, chronic abdominal pain, type 2 diabetes mellitus, chronic opioid use, known allergies: Latex from an unknown date and unknown if ongoing. No other vaccine in four weeks. No COVID prior vaccination and was not tested for COVID post vaccination. The patient's concomitant medications were not reported. The patient previously took sulfamethoxazole;trimethoprim and experienced allergies to Sulfamethoxazole-trimethoprim. The patient experienced lower extremity pain and swelling, lower extremity pain and swelling, blue toes on both feet, extensive deep vein thrombosis in left lower extremity requiring treatment and thrombectomy, legs were cool to touch on 02Apr2021; and he reported discoloration resolved but developed worsening bilateral lower extremity edema on an unspecified date. Clinical course was reported as follows: The patient presented to the hospital on "4/7" (as reported) with lower extremity pain and swelling. Patient reports received 1st dose on pfizer vaccine on 4/2 (as reported) and immediately noticed blue toes on both feet and legs were cool to touch. He reports discoloration resolved but developed worsening bilateral lower extremity edema. Imaging revealed extensive deep vein thrombosis in left lower extremity requiring treatment and thrombectomy. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: negative on 07Apr2021, and sars-cov-2 antibody test (nasal swab): negative on 13Apr2021. Treatment was received for the events. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization (Apr2021). Outcome of the events was recovering. Information on the lot number has been requested.
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| 51 | 2021-04-28 | speech disorder, facial paralysis, one side paralysis, slurring |
Within 30-minutes of vaccination, the patient reported a headache, slurred speech, and right side we...
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Within 30-minutes of vaccination, the patient reported a headache, slurred speech, and right side weakness. EMS evaluated the patient on-site. The patient was hypertensive (197/129) with a FSBG of 95mg/dL. During stroke assessment, the patient had new onset facial palsy/droop and need speech abnormality which signaled a stroke alert. 12-lead EKG was unremarkable. EMS transported the patient to Emergency Department. In the ED, the patient presented with a headache, chest heaviness, and slurred speech, but no aphasia. NIH stroke scale was 0. Patient remained hypertensive (170/109). Labs, tests, and imaging did not indicate rtPA administration. ED physician administered 0.4mg SL Nitroglycerin, 10mg IV Hydralazine, and 325mg PO Aspirin prior to admission for suspected Transient Ischemic Attack. Upon admission, differential was TIA vs. CVA vs. ACS. Admitting physician ordered HbA1C, lipid panel, MRI brain, CTA head/neck, 2D echo, and neurology consult. Throughout course of admission, patient had recurring midsternal chest pain that was relieved with Nitroglycerin. Imaging ruled out CVA. Given elevated TGs and Cholesterol, patient was started on Atorvastatin 40mg PO. Suspected TIA and ACS. Neurology consult reviewed the labs and imaging, and stated the episodes of stuttering are most commonly associated with anxiety or stress reaction. Neuro did not recommend any further workup unless this happened again unprovoked. Patient was discharged after a 3-day admission with diagnosis of cerebrovascular disease, unspecified. The patient was prescribed 81mg PO Aspirin, 20mg PO Lisinopril, and 40mg PO Atorvastatin.
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| 51 | 2021-04-28 | unresponsive to stimuli |
Systemic: Fainting / Unresponsive-Mild, Additional Details: Fainted five minutes after receving 2nd ...
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Systemic: Fainting / Unresponsive-Mild, Additional Details: Fainted five minutes after receving 2nd dose. Hx of fainting due to needles. Reported not eating or drinking prior. Fainted from the chair and broke small fragment of glasses. Did not injure his head. Interventions: bottle of orange juice and water, lifting legs and having him laydown/ sit up for 15 minutes. Walked him to car with his partner ensuring safety. First set of vital signs taken at 1800 (3pm): 96 degrees F, 55 bpm, 102/62, 14 RR. 1815 vitals: 66bpm, 16 RR, 96.8F, 118/84 BP.
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| 51 | 2021-04-29 | weakness |
Patient reports swollen glands, blisters inside nose and mouth, achy body, and pain similar to his p...
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Patient reports swollen glands, blisters inside nose and mouth, achy body, and pain similar to his past shingle infections. Patient believes he is now having an outbreak of shingles. Patient also reports feeling overall very weak 48 hours after the vaccine.
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| 51 | 2021-04-29 | pain in extremity |
Within a day of 2nd Pfizer dose (intramuscular, left shoulder) had flu-like symptoms (aching joints,...
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Within a day of 2nd Pfizer dose (intramuscular, left shoulder) had flu-like symptoms (aching joints, tired, chills, swelling under jawline, metallic taste in mouth) but they disappeared by third day from date of vaccination. By the 10th day after vaccination had developed intense shoulder pain radiating from shoulder to mid-arm (left arm) and upper back (trapezius/neck). Went to local Urgent Care next day and was X-rayed and given the following: Methylprednisolone - 4MG (tapered dosage) ? Shoulder/trapezius muscle pain/inflammation Cyclobenzaprine - 10MG ? Muscle relaxant for shoulder/trapezius muscle pain/inflammation. By end of tapered does still feeling intense ache/throb and pain in same areas.
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| 51 | 2021-05-04 | inability to speak |
The next day I noticed a measles like red spotty rash all over my arms legs and torso. This rash at...
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The next day I noticed a measles like red spotty rash all over my arms legs and torso. This rash at first did not itch but later itched mildly and intermittently this rash continues today, May 5th 2021. Furthermore I've suffered what I can only describe as brain fog that has left me discombobulated, absent mind, stumbling for words. Also my mood is significantly altered as I am suffering from anxiety and a short temper.
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| 51 | 2021-05-05 | flushing | Flushed face, "felt like I had a glass of wine." Felt dazed. |
| 51 | 2021-05-06 | night sweats |
Post nasal drip, sore throat, cough, sinus pressure, nasal irritation, fatigue, night sweats, burnin...
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Post nasal drip, sore throat, cough, sinus pressure, nasal irritation, fatigue, night sweats, burning in chest stay well-hydrated and well-nourished while resting appropriately For cough: honey 1 to 2 teaspoons every 4 hours can help to quiet a cough buPROPion SR (WELLBUTRIN SR)
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| 51 | 2021-05-06 | tingling, numbness |
Tingling in hands and feet; numbness in toes , lose control of legs and arms not being able to walk ...
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Tingling in hands and feet; numbness in toes , lose control of legs and arms not being able to walk and a lot of pain. I was treated with plasma IVIG , and steroids. Still in rehab
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| 51 | 2021-05-07 | pain in extremity |
I had an ultrasound done on my leg where a blood clot was found. I had a chest CT performed where se...
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I had an ultrasound done on my leg where a blood clot was found. I had a chest CT performed where several clots were found; Two days after my vaccine I began having severe pain in my right leg in the calf area and pain in my chest when I took a deep breath or coughed. Over the weekend it got worse and worse, on Tuesday th; Pain in my chest; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 14Apr2021 13:00 (Batch/Lot Number: Ew0153) (at the age of 51 years old) as single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included duloxetine; trazodone; pregabalin (LYRICA); oxycodone hydrochloride, oxycodone terephthalate, paracetamol (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]); and meloxicam, all taken for an unspecified indication, start and stop date were not reported. The patient previously took vancomycin and daptomycin and experienced drug allergy to these medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 16Apr2021 09:00, two days after the vaccine, the patient began having severe pain in his right leg in the calf area and pain in his chest when he took a deep breath or coughed. Over the weekend, it got worse and worse, on Tuesday 20Apr2021, the patient had an ultrasound done on his leg where a blood clot was found. He had a chest computerized tomography (CT) performed where several clots were found. The event resulted in doctor or other healthcare professional office/clinic visit. The treatment included blood thinners. No COVID prior vaccination and not COVID tested post vaccination. The case was assessed as non-serious by the reporter. The outcome of the event was not recovered.
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| 51 | 2021-05-10 | migraine, night sweats |
dehydration; low blood sugar; fatigued; Appetite; Pneumonia; Night sweats; Headache; Couldn't eat an...
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dehydration; low blood sugar; fatigued; Appetite; Pneumonia; Night sweats; Headache; Couldn't eat anything; Wheezing; migraine; Light, hacking cough; Fever/ 103.9 degrees; Chills; No more than 2-3 hours of sleep per night for 5 nights; Short of breath; This is a spontaneous report from a contactable consumer (patient). A 51-years-old male patient received the second dose of BNT162B2 (COVID-19 VACCINE), via an unspecified route of administration, administered on left arm on 14Apr2021 10:45 (Batch/Lot number was not reported) at age of 51 years as single dose. The patient medical history and concomitant medications was reported as none. Historical v for covid-19 immunisation accine included the first dose of BNT162B2 administered on left arm on 24Mar2021 at age of 51 years for covid-19 immunisation and experienced no issues. Patient reported that after the second dose of the Covid-19 vaccine, he had a fever for 8 days and was diagnosed with pneumonia on 21Apr2021. Patient reported that he was tested for both Covid-19, Influenza A, and Influenza B twice on 19Apr2021 and 21Apr2021 and tested negative for Covid-19 and influenza both times. Patient reported that he had no pre-conditions and that he was feeling great the night before he received the second dose of the Covid-19 vaccine, 13Apr2021. Patient reported that he was planning to go to work following the second dose of the Covid-19 vaccine on 14Apr2021. He began running a low-grade fever (102 degrees) on 14Apr2021 after receiving the Covid-19 vaccine and then his temperature flared up to 103.5 degrees on 15Apr2021. Fever: He received the second dose of the Covid-19 vaccine at 10:45 on 14Apr2021 and about 2:00 in afternoon on 14Apr2021 was the first fever that was significant. The last fever he had on 21Apr2021, his temperature was 103.9. He was put on antibiotics for pneumonia. He contacted the on-call nurse for his company. The on-call nurse advised him to see a doctor on Saturday, 17Apr2021.He went to the doctor on Monday, 19Apr2021. The doctor only ran a Covid-19 swab for testing and a flu swab. His doctor did not do blood work and stated that the patientwas experiencing an ill effect of the Covid-19 vaccine and sent the patient home. He went back to the doctor on Wednesday, 21Apr2021. When he went back to the doctor, the staff performed a chest X-ray and ran 4 different blood works to see what the patient had. The second Covid-19 test that he received on 22Apr2021 was performed with both the rapid test and the test that was sent off. Both Covid-19 tests came back negative. SARS test on 22Apr2021 was negative. 508-3 High Sensitivity CRP: One of his numbers that was parts per liter, 3 is considered to be high risk and he had 300 (300+) of whatever it was on 21Apr2021. He went back to the physician and was given another steroid shot an additional prescription. He had been back to the doctor 3 times since then. Fever: His fever was 103 consistently after 15Apr2021. 508-3 High sensitivity CRP: This value showed abnormal. The results said that relative risk was greater than 1 mg/liter and high was greater than 3. 1000 CBC with auto differential on 21Apr2021: The abnormal results were red blood cells measured at 4.38; hematocrit measured at 13.82; MCHC measured at 36.4; Neutrophils measured at 84; Lymphocytes measured at 12; and absolute Lymphocytes measured at 0.57. He wore a Garmin and that it recorded that he received no more than 2-3 hours of sleep per night for 5 nights. He didn't know anything about pneumonia previously and that he had specifically told his physician's office everything about what he was experiencing. He told his physician about the wheezing in his chest (on 17Apr2021), cough (on 16Apr2021), fever, and chills (on 14Apr2021). His physician told him it was a normal reaction to the Covid-19 vaccine and sent him home on 19Apr2021. He then consulted Google and started to realize that his side effect were very atypical. Wheezing: When he breathed really light, the crackling would continue. If he breathed shallow, the wheezing was audible but if he breathed deeply, it was not. The pneumonia was in the left side of his chest. He was still being treated for the pneumonia. He has his last dose of medication tomorrow, 27Apr2021, and that he was also being released to go back to work tomorrow. Cough: He had a little cough that would then go away. The cough began late Friday, 16Apr2021. It was interesting because it wasn't a main part of the illness. The cough was just kind of a hacking cough every once in awhile. The cough was not continuous like go and go and go and stop. The cough came, went away for awhile, then came again.The cough being worse was relative. He was coughing more than he did on Wednesday 21Apr2021, Thursday 22Apr2021, and Friday 23Apr2021. The cough was consistent more so at night when he laid down. He would probably say that it was a different feel towards the cough but it was still a cough. The cough was still the same volume but not the same effect. Headache (on 18Apr2021): He had been waking up with headaches in the morning and going to bed with them at night. On Wednesday, 21Apr2021, the headache was due to dehydration from the fever and night sweats. Once he got away from the dehydration headaches, the headache got better but he had woken up with a headache the last few days and had a headache at bedtime a few nights in a row. The headache was usually a frontal headache and this morning, 26Apr2021, the headache was toward the back of his head. The headaches last a few hours until he started moving around. On Saturday, 17Apr2021 he experienced a migraine that would not go away. He didn't usually get migraines. The migraine lasted hours if not for a day and that the headache was something furious. Sunday 18Apr2021 was pretty much the same thing with the headache. Because of the massive fever, he couldn't eat anything at all (17Apr2021). The headache was mostly due to low blood sugar and dehydration. Appetite: His appetite improved after his second doctor's appointment on 21Apr2021. The second provider was a lot more straightforward and advised the patient that he needed to start taking care of himself and trying to force himself to eat. He forced himself to eat on 21Apr2021 and by Thursday 22Apr2021, he had a full appetite and was craving food again. Shortness of breath (Apr2021): Patient reported that the shortness of breath was just from being fatigued. Patient reported that he got out of breath from going up and down the stairs. He was unsure when the shortness of breath began because he was moving very little, but that he noticed the shortness of breath on Monday, 19Apr2021 when he got up to go to the doctor.On Friday 16Apr2021 and Saturday 17Apr2021, he had a really good break.On Friday 16Apr2021 from 9 AM to 1 PM, he had no fever and it was like the sun was coming out, then the fever hit really hard. The same thing happened on Saturday, 17Apr2021, but the fever free period lasted maybe a little longer. His fever returned and that the afternoon of Saturday 17Apr2021 was the worst he had been the entire time. On 13Apr2021 to get away from arm soreness, he did a few laps in the pool. On 13Apr2021 he had a new best time on the 100 in freestyle in the pool and that he felt really strong going into 14Apr2021 to get his second dose of the Covid-19 vaccine. There was nothing that would have indicated that he had anything going on before getting the second dose of the Covid-19 vaccine. Up until Saturday, 17Apr2021, he had only been taking Motrin and just taking 2 tablets. He had no break in between fevers and chills and was not able to get ahead of the fever with the Motrin. There was a long stretch where the Motrin wasn't working and his temperature didn't get below 100 for several days. He tried to cycle acetaminophen in beginning Saturday 17Apr2021 to try to get the acetaminophen in between the Motrin doses. When he went back to the doctor on 21Apr2021, the provider told him that he could take 3 to 4 Motrin tablets at a time but not to exceed 4 doses per day. He never took more than 3 tablets. Motrin was generic ibuprofen. Night sweats (on 21Apr2021): The last couple of nights have been the same. He had a fan on to keep a little cooler and that it was 61 degrees outside and he felt the night sweats. He had a buckwheat mat that was cool that he put on the floor to stay cooler with the night sweats. Come Thursday, 22Apr2021, he said we're done with this and he couldn't sleep from it (Apr2021). Last night, 25Apr2021, he knew that he had night sweats because he was sweating at night and the temperature in the room was 64 degrees. AEs did not require a visit to Emergency Room. AEs required a visit to Physician Office for fever, wheezing, cough, shortness of breath, chills. Outcome of events was unknown.
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| 51 | 2021-05-12 | discomfort |
ED to Hosp-Admission Discharged 2/23/2021 - 2/25/2021 (2 days) Treatment team Costochondritis Princ...
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ED to Hosp-Admission Discharged 2/23/2021 - 2/25/2021 (2 days) Treatment team Costochondritis Principal problem Discharge Summary (Physician Assistant) ? ? Internal Medicine Cosigned by: MD at 2/27/2021 4:06 PM Discharge Summary Hospitalist Medicine Admission Date: 2/23/2021 Length of Stay: 0 Days Discharge Date: 2/25/2021 Admission Diagnosis Hospital Problems POA * (Principal) Costochondritis Yes COVID-19 Yes Problem List Resolved POA Resolved Problems Atypical chest pain 2/25/2021 Yes SIRS (systemic inflammatory response syndrome) (CMS/HCC) 2/25/2021 Yes Hyponatremia 2/25/2021 Yes Dehydration 2/25/2021 Yes Home Or Self Care CODE STATUS: Full Code Active Issues Requiring Follow-up Test Results Pending at Discharge Pending Labs Order Current Status Blood culture x 2 SETS Preliminary result Blood culture x 2 SETS Preliminary result Hospital Course Hospital Course: Please refer to the admitting providers H&P for full history. Patient is a 51-year-old male with a PMHx significant for hemochromatosis, sarcoidosis and morbid obesity who initially presented to the ED for evaluation of chest pain, cough and shortness of breath. On presentation, vitals were mostly unremarkable other than some mild tachycardia and tachypnea. Patient was able to maintain adequate oxygenation on room air but was placed on supplemental oxygen for comfort. Blood work was mostly unremarkable. ABG was not particularly concerning. Troponin was negative x3. Patient underwent chest CTA which showed basilar atelectasis bilaterally and scattered groundglass opacities and scattered borderline size hilar and mediastinal lymph nodes consistent with patient's known sarcoidosis. Patient was treated with supportive care and monitored overnight. He was able to maintain sufficient oxygen levels. On the time my evaluation, patient continues to complain of bilateral rib pain worse with deep breaths consistent with costochondritis. I discussed with the patient that he will need to continue to take NSAIDs on a scheduled basis to help with his discomfort. Additionally I offered to prescribe cough medicine. I discussed possibly discharging the patient on steroids however he states that he makes a point to avoid taking steroids due to his history of hemochromatosis. At this point, patient no longer requires care in the hospital and can be discharged home. Patient is agreeable with the plan and all questions have been answered appropriately.
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| 51 | 2021-05-13 | cold sweat |
Intense Headache 7-10 of 10; Low grade fever 100.4; Significant bodyaches; cold sweats; This is a sp...
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Intense Headache 7-10 of 10; Low grade fever 100.4; Significant bodyaches; cold sweats; This is a spontaneous report from a contactable other health care professional (Patient, self-reported). A 51-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL3247) via an unspecified route of administration, administered in arm left on 27Jan2021 07:30AM, as second dose, single, dose 1, (Batch/Lot Number: EJ1686), via an unspecified route of administration, administered in Arm Left on 06Jan2021 07:30AM, as first dose, single for covid-19 immunization. Reportedly other medical history was none. Patient did not have allergies to medications, food, or other products/known allergies. Concomitant medication included paracetamol (TYLENOL) and ibuprofen (MOTRIN [IBUPROFEN]) received in two weeks of vaccinations. Patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with COVID-19 prior vaccination. Patient has not been tested for COVID-19, post vaccination. On 28Jan2021 02:45AM, the patient experienced intense headache 7-10 of 10, low grade fever 100.4, significant body aches and cold sweats. The patient underwent lab tests and procedures which included pain assessment: 7-10 of 10 and pyrexia: 100.4 on 28Jan2021. Treatment was not received for adverse events. Outcome of the events was recovering. Follow-Up (15-Apr-2021): Follow-up attempts are completed. No further information is expected.
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| 51 | 2021-05-14 | numbness, bell's palsy |
Palsey on left side. Watering left eye. Numbness on left side around mouth and cheek.; Palsey on l...
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Palsey on left side. Watering left eye. Numbness on left side around mouth and cheek.; Palsey on left side. Watering left eye. Numbness on left side around mouth and cheek.; Palsey on left side. Watering left eye. Numbness on left side around mouth and cheek.; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in right arm on 29Mar2021 10:00 (Batch/Lot number was not reported) at the age of 51 years old, as 2ND DOSE, SINGLE for COVID-19 immunisation. Medical history included mitral valve prolapse. Concomitant medication included warfarin taken for an unspecified indication, start and stop date were not reported. The patient previously took doxycycline hydrochloride (DOXYCYCLIN) and experienced allergy. The patient previously received first dose of bnt162b2 on 09Mar2021 09:00 AM at the age of 51 years old for COVID-19 immunization (vaccine location: right arm). No other vaccines received within 4 weeks prior to COVID vaccine. On 05Apr2021 07:00, the patient experienced Palsy (palsey) on left side, watering of left eye and numbness on left side around mouth and cheek. No treatment was received for the adverse events. The patient recovered from all the events on unspecified date. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. Information on the lot/batch number has been requested.
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| 51 | 2021-05-21 | numbness and pain in extremities, tingling, pain in extremity |
allergic reaction to the Covid 19 vaccine; nerves in his right wrist are bothering him, feels the ne...
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allergic reaction to the Covid 19 vaccine; nerves in his right wrist are bothering him, feels the nerves moving up and down and his arms, and feeling like the nerves in his right arm were jumping; right hand won't relax, can't bend the fingers on his right hand, can't make a fist with his right hand; like he has no control of his arm; right wrist feels like needles and pins; right hand blew up with inflammation; His fingers on his right hand were swollen, right hand looked like it was going to explode; Like his right arm was agitated, right arm was still very uncomfortable; pain in his hand; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received the second dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: EW0164), at the age of 51 years old, in right arm at single dose on 23Apr2021 16:30 for covid-19 immunization. Medical history included sleep apnea, congestive heart failure, high blood pressure and type 2 diabetes, seasonal allergy and covid-19 in May2020. The patient reported he had symptoms of the covid-19 virus in May2020. He had a positive covid-19 virus test and did quarantine. The patient reported he's never been allergic to any kind of medication. Concomitant medications included atenolol 50-25 mg at one tablet a day. The patient didn't know the name of the other medication combined with the atenolol. The patient reported one was for the heart and one was for the blood. He also took medication for seasonal allergies but declined to provide the name. The patient previously received a flu vaccine (NDC/Lot/Expiry: unknown) on 2020 that made him feel bad with a head cold. The patient previously received the first dose of BNT162B2 (lot number: EP7534), at the age of 51 years old, in right arm at single dose on 02Apr2021 16:30 for covid-19 immunization. The patient started having some problems maybe a week after that. He started feeling like the nerves in his right arm were jumping. Like his right arm was agitated. His finger on his right hand were swollen. The patient did get his vaccine in the right arm. He thought his arm was going to bother him after he got the vaccine. The nerves in his right wrist are bothering him. Like he felt the nerves moving up and down and his arms, like he had no control of his arm. His right hand blew up with inflammation. His right hand looked like it was going to explode. His right hand won't relax. On 01May2021 was when he noticed his arm acting funny. He would say that the swelling had gone down from taking the antibiotics but his right arm was still very uncomfortable and he couldn't bend the fingers on his right hand and he couldn't make a fist with his right hand. His right wrist felt like needle and pins. The patient went to the emergency room at a hospital two nights in a row on 04May2021 and 05May2021. The first time he had x-rays done. The second time he had x-rays and a sonogram of his right arm to check for blood clots and he had some blood work done. All of that came back negative. The emergency room doctor asked him what arm did receive BNT162B2 in, he told the doctor his right arm, the doctor told him he's having an allergic reaction to BNT162B2. The emergency room doctor prescribed him an antibiotic to take. He'd already finished the antibiotic and didn't recall the name, the bottle had been thrown away. The patient followed up with his primary care doctor on 13May2021 and was given a prescription for a muscle relaxer and motrin 600 mg to help bring the swelling and pain down in his hand. In the emergency department he had a right arm and right wrist x-ray. The doctor was trying to figure out why his right hand looked like a balloon. The only conclusion the emergency room doctor came up with was that he was having a reaction to BNT162B2. The outcome of events nerve in wrist bothering, felt nerve moving, feeling nerves jumping, right arm agitated, no control of arm, right hand won't relax and couldn't bend fingers was not recovered. The outcome of events hand blew up with inflammation, fingers on right hand swollen, right hand explode and pain in hand was recovering. The outcome of events wrist felt like needles and pins and allergic reaction to vaccine was unknown. No follow-up attempts are needed. No further information is expected.
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| 51 | 2021-05-24 | numbness |
Around 6 AM March 24 about 30 hours after my first injection of the Pfizer vaccine I experience stro...
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Around 6 AM March 24 about 30 hours after my first injection of the Pfizer vaccine I experience stroke like symptoms. Numbness on the left side of my body. Including my face arm and leg. I went to hospital. Where I was first given a CAT scan. And a day later an MRI.
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| 51 | 2021-05-24 | tingling, flushing |
heart races a little; feels flushed; checked his pulse and it was a little elevated; eyes are tingly...
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heart races a little; feels flushed; checked his pulse and it was a little elevated; eyes are tingly; feeling feverish but no fever; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 51-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, #lot: EL9262) via an unspecified route of administration administered in Arm Right on 25Jan2021 14:00 (at the age of 51-years-old) as single dose for covid-19 immunisation. The patient's medical history included blood pressure. The patient's concomitant medications included hydrochlorothiazide, losartan potassium (LOSARTAN HCTZ) ongoing at 12.5 of unknow units once daily for blood pressure and tamsulosin. The patient underwent lab tests and procedures which included heart rate: little elevated. He checked his pulse and it was a little elevated. It was reported as the patient received the first dose of the pfizer covid 19 vaccine on Monday 25Jan2021 but did not have any symptoms until Thursday 28Jan2021. The patient reported feeling feverish but no fever, heart races a little, eyes are tingly and feels flushed. The patient wants to know if what he is experiencing normal. The patient wanted to know if the rumor is true that the second dose has more side effects. He has had no allergic reactions to medicine. He takes a blood pressure medicine, anti-anxiety medicine, and cholesterol medicine. Starting yesterday he started to feel feverish but had no fever. His eyes started to feel tingly, like a feverish feeling. This started after lunch time. He took a nap for like an hour, slept fine, and then the feeling was gone and he was okay. Today, he woke up this morning around 6:30 AM and was fine. It was not until later this morning around 11 AM when he started to feel the same way again. It was like his heart raced a little. He checked his pulse and it was a little elevated, but nothing crazy. He felt flushed. His eyes were tingly. It is like something does not feel right. He was calling to see if these were side effects. Feeling like his heart was racing has subsided. It was worse earlier. The feeling flushed is minor now. The eyes tingly has almost subsided, but still there. The patient experienced feeling feverish but no fever, eyes are tingly on 28Jan2021, heart races a little, feels flushed and checked his pulse and it was a little elevated on an unspecified date. The outcome of the events heart races a little and eyes are tingly and feels flushed was recovering, while the outcome of remaining events was unknown. Follow-up attempts are completed. No further information is expected.
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| 51 | 2021-05-26 | involuntary muscle movements |
On 5/20/21 the patient was at home with his mother when he had acute nausea, light-headedness, and a...
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On 5/20/21 the patient was at home with his mother when he had acute nausea, light-headedness, and abdominal pain. He presented to the ED by ambulance. Excerpt from ED notes od MD follows: "Initial ED interventions: iv fluids, low dose iv ativan, iv toradol, iv zofran. ED course: patient arrives very anxious, writhing on bed, difficult to redirect. With chronic tonicity, not seizing. Mother arrives, and he recognizes her, seems to be consoled somewhat by her presence, but she is unable to direct him, and describes his behavior as irregular, and events acute this evening at her home. Patient rests, and then HR decrease to 50s on monitior and patient found to be pulseless - I immediately start chest compressions, and achieve ROSC after PEA arrest with administration of EPI/compressions. Patient intubated per procedure note without complication. L femoral central attained per procedure note without complication. CPR performed over ED course intermittently (always PEA arrest) with ROSC achieved with administration of EPI, EPI drip started in addition to sedation meds, and iv fluids. No obvious STEMI on ECG to administer lytics, with suspicion of dissection and AAA prominent. I am able to stabilze and accompany patient to CT suite, where I recognize B/L massive PE immediately. I discuss with Dr. of Cardiology, who agrees with admininstration of alteplase. I disucss risks with mother who consents verbally. Patient without response to alteplase, and with continued pattern of PEA arrest following bradycardia. I discuss etiology of presentation with mother,and that patient is with very poor prognosis of survival, and likely poorer prognosis of neurological status, and patient is made comfort care, and fentanyl drip increased, patient is taken off of ventilation and drips. Pronounced deceased at 22:00. MDM: Initial concern for but not limited to appendicitis, AAA, diverticulitis, renal stones, pyelonephritis, musculoskeletal pain, pancreatitis, toxic ingestion, ACS, obstruction, perforation, sepsis (2/2 PNA, UTI, meningitis, intra-abdominal infection), AAA, dissection, PE - as ED course progresses, differential narrows and consider more likely PEA arrest secondary to ACS, PE, dissection, AAA, necrotic pancreatitis, tension PNX (less likely). Considered but do not suspect seizures, stroke. Imaging studies reviewed - CXR with ETT in place, no acute pathology. CTA chest/A/P remarkable for massive proximal B/L PE. Labs reviewed. ECGs without STEMI, with sinus tach initially, LBBB after initial ROSC, and then AFib in RVR on subsequent ECG. Per above, patient suffered massive B/L PE, with subsequent cardiac arrest, despite heoric efforts including thrombolysis. Death called art 22:00. Diagnosis: massive B/L PEs, PEA arrest. Disposition: deceased."
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| 51 | 2021-05-28 | tingling |
Paresthesia-like effect experienced on finger, right hand thumb. Treatment ?Dermoplast? spray (benz...
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Paresthesia-like effect experienced on finger, right hand thumb. Treatment ?Dermoplast? spray (benzotgonium chloride/benzocaine) followed by ?Neosporin? (bacitracin/neomycin/polymyxin). Reason for for selected treatment was initial suspected cause of potential insect sting. No skin puncture was found or other signs of insect bite. This symptom has never been experienced by patient before. The symptom laster approximately 30 minutes.
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| 51 | 2021-05-30 | feeling cold |
Very sluggish,cold not chills no fever,out of sorts feeling,lasted only 1 day,feeling better on 2nd...
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Very sluggish,cold not chills no fever,out of sorts feeling,lasted only 1 day,feeling better on 2nd day
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| 51 | 2021-05-31 | pain in extremity |
constant headache; had body pain & aches; extreme fatigue; pain in entire upper arm; This is a spont...
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constant headache; had body pain & aches; extreme fatigue; pain in entire upper arm; This is a spontaneous report from a contactable other hcp (patient). A 51-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: en6202; Expiration Date: unknown), dose 2 via an unspecified route of administration, administered in left arm on 24Feb2021 15:00 (at the age of 51-year-old) as 2nd dose, single dose for COVID-19 immunization. The patient received the historical vaccine BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: el9269; Expiration Date: unknown) via an unspecified route of administration, administered in left arm on 03Feb2021 17:00 (at the age of 51-year-old) as 1st dose, single dose for COVID-19 immunization. The patient had no other medical history. Concomitant medications in two weeks included acetylsalicylic acid (ASPIRIN 81) at a dose of 81 mg, atorvastatin (ATORVASTATIN), multi vitamin. There was no other vaccine on same date or in four weeks of product. The patient did not had COVID prior to vaccination. The patient has not been tested for COVID post vaccination. On 25Feb2021 12:00, the patient experienced constant headache, body pain and aches, extreme fatigue, pain in entire upper arm. Reportedly, constant headache, started 25Feb2021 12pm still present (26feb2021), had body pain & aches, extreme fatigue, pain in entire upper arm until 26Feb2021 06:00, headache still present 26Feb2021 at 20:00. No treatment was given for adverse event. The clinical outcome of the events was not recovered. Follow-up attempts completed. No further information expected.
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| 51 | 2021-06-01 | pain in extremity |
Dose 2. Sore arm; Headache; Fatigue; Vertigo; This is a spontaneous report received from a contactab...
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Dose 2. Sore arm; Headache; Fatigue; Vertigo; This is a spontaneous report received from a contactable consumer (reporting on himself). A 51-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Ew0167 and Expiration Date was not reported) via an unspecified route of administration in Arm Right on 19May2021 18:30, as 2nd dose, single dose for COVID-19 immunization. Medical history included, vertigo from 2019 to an unknown date. The patient's concomitant medications were not reported. Patient did not have known allergies. Previously patient took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Ek8735 or ER8735 and Expiration Date was not reported) via an unspecified route of administration in Arm Right on 24APR2021 04:00, as 1st dose, single dose for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19 and did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 20May2021 08:00, patient experienced dose 2. sore arm, headache and fatigue first 48 hours; vertigo and significant fatigue began at 48 hour point has continued for two days. Has a bout of vertigo around 2019 that lasted weeks. Patient did not received any treatment for adverse events. Since the vaccination, the patient has tested for COVID-19. The outcome of the events was not recovered.
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| 51 | 2021-06-03 | weakness |
Rapid heart rate. Resting rate of 120 to 130 beats per minute for at least 2 days. Then 100 to 110 f...
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Rapid heart rate. Resting rate of 120 to 130 beats per minute for at least 2 days. Then 100 to 110 for another 2 days. After 2 weeks still having trouble with normal activities. Heart beat feels different and I get weak whenever moving quickly for example doing laundry or cleaning the house.
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| 51 | 2021-06-03 | weakness |
Fatigue; muscle pain; low grade fever; chills; excessive sweating; headache; back pain; generalized ...
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Fatigue; muscle pain; low grade fever; chills; excessive sweating; headache; back pain; generalized weakness; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6199), via an unspecified route and administrated in the left arm on 16Mar2021 at 16:45 hours (at the age of 51-years-old), as a single dose for COVID-19 immunisation. Medical history included hypertension which was controlled. Patient was not allergic to medications, food, or other products. Concomitant medication included amlodipine besylate 10mg (MANUFACTURER UNKNOWN) and hydrochlorothiazide 25mg (MANUFACTURER UNKNOWN) for an unknown indication. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. On 17March2021 at 14:00 hours, patient experienced fatigue, muscle pain, low grade fever, chills, excessive sweating, headache, back pain and generalized weakness. Patient did not receive any treatment for the reported events. On an unknown date in Mar2021, the patient was recovered from the events fatigue, muscle pain, low grade fever, chills, excessive sweating, headache, back pain and generalized weakness. No follow-up attempts are needed. No further information is expected.
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| 51 | 2021-06-03 | migraine |
Vomiting; Massive Migraine; Pain in neck; Dizziness; Headache; Nausea; Made me sick; This is a spont...
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Vomiting; Massive Migraine; Pain in neck; Dizziness; Headache; Nausea; Made me sick; This is a spontaneous report from a contactable consumer (Patient). A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: EW0167; Expiration Date: 31Aug2021), via an unspecified route of administration on 20May2021 at 16:30 (at the age of 51-year-old) as 1st dose, single dose in right arm for COVID-19 immunisation at Public Health Department. The patient's medical history included arthritis and gout. The patient had known allergies to amoxicillin. Concomitant medications within 2 weeks of vaccination included allopurinol (ALLOPURINOL) taken for gout, celecoxib (CELEBREX) taken for arthritis, gabapentin (GABAPENTIN), and buprenorphine (BUPRENORPHINE). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 20May2021 at 22:30, after the first shot of vaccine, the patient experienced massive migraine, pain in neck, dizziness, vomiting, headache, and nausea. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Treatment medication included Sumatriptan Succinate 50mg and then 100 mg (Manufacturer: Aurobindo). On an unspecified date in May2021, the patient reported that the Pfizer shot had made her sick. The patient underwent lab tests and procedures on Apr2021 which included blood test: unknown results and patient had several blood test over the last month. The patient had no COVID prior vaccination and was not tested COVID post vaccination. The clinical outcome of the event made me sick was unknown and clinical outcome of all other events was not resolved.
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| 51 | 2021-06-03 | tenderness |
Left armpit is swollen and tender; Left armpit is swollen and tender; Is the same side as the inject...
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Left armpit is swollen and tender; Left armpit is swollen and tender; Is the same side as the injection; Typical soreness where the shot was; This is a spontaneous report received from a contactable consumer or other non hcp. A 51-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch number: ER8731 and Expiry date: Unknown), via an unspecified route of administration, on 24May2021 13:00 as 1st dose, single dose on left arm for Covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient had the shot on typical soreness where the shot and Is the same side as the injection has not really had any side effects until this morning. On the same date he got the shot he had some tenderness at the site. The patient experienced left armpit is swollen and tender and is the same side as the injection on 27May2021. The events assessed as non-serious. The patient initially stated this was subsided, but clarified it was still ongoing even though he initially said he had no side effects until today as well. If he touches it, it was still tender. Outcome of the events Is the same side as the injection and Typical soreness where the shot was resolving while outcome of the remaining events was unknown. Information on Lot/Batch number is available; Further information has been requested
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| 51 | 2021-06-06 | muscle twitching |
I began having a constant eye twitching in my left eye approximately two weeks after my second shot....
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I began having a constant eye twitching in my left eye approximately two weeks after my second shot. It has been twitching since then and it is now June 7th. I am unsure of this is a reaction to the vaccine.
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| 51 | 2021-06-07 | pain in extremity |
axillary lymphadenopathy/Lymphadenopathy was evident in the left axilla/large lymph nodes; full blow...
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axillary lymphadenopathy/Lymphadenopathy was evident in the left axilla/large lymph nodes; full blown flu like syndrome with headache, body ache and flu like chills, nasal drainage and eyes watery/ congested, nose running like a faucet non stop; sore throat; severe right deltoid pain; arm very tender and swollen; fees like crap and is hard to get out of bed every morning; rhinitic, congested, draining like a faucet; severe pain in left foot and right hand; Has been fatigued and his body aches and he is exhausted.; He couldn't even walk, it was completely painful.; This is a spontaneous report from a contactable physician (patient). A 51-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 04May2021 (at age of 51 years old) (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. Medical history included flu, has gotten the flu before but has never gone on this long. The patient's concomitant medications were not reported. Clinical course as reported: He is a practicing physician who has been providing vaccinations to patients all of his life. He ended up with severe right deltoid pain. It is usually not a problem, he has dealt with this with other shots. By the second or third day, it was very tender and swollen and had axillary lymphadenopathy on the same side he re-ceived the vaccination. It persisted the next day until day 5 or 6. He then started to get worried. He went to the hospital. They did a CT scan which noted there was notable lymphadenopathy. They thought it was a reaction to the Covid vaccination. 2 days later, he went home and he kept taking Motrin and Tylenol on board. Lymphadenopathy was evident in the left axilla, inguinal nodes, and is still there now. On day 7, he went into full blown flu syndrome, had a headache, body aches and flu like chills, the whole thing. Is still a little bit rhinitic and is very congested, and is draining like a faucet. It has all been happening since he got vaccinated. He was told he was either exposed to covid or it is from the vaccination. He went to urgent care yesterday (20May2021) and they did a Covid test which was negative. He hates to point fingers but this fatigue has been overwhelming and is never ending. He called withheld where he got the vaccination. He said the pharmacist has been hearing this from a lot of patients. He reported for 7 days straight the clinical events as they were happening. Nobody has contacted him, they said some-one would be contacting him the next day and he has not heard from anyone. This laid him up for 5 days. The last 4 days, he had severe pain in the left foot, and the right hand. It was out of the blue like someone whacked him with a hammer. He couldn't even walk, it was completely painful. He hasn't worked out since he got the damn shot. In 15 days, he has not gone to the gym. They did an X-ray which didn't say anything. He was in immense pain. They gave him prescription for Prednisone 50mg and he hasn't been able to get to the pharmacy to get it yet but will head over shortly. Has been taking Motrin and Tylenol around the clock. Has been taking antihistamines because his nose has been running like a faucet non stop and he has a sore throat. Sore throat has gotten better in the last 5 days. The pain was really bad. The sore throat has subsided. The nasal drain-age and his eyes are watery are still there. Has been fatigued and his body aches and he is exhausted. The second vaccination is due 25May2021 and he is absolutely not getting the second one. When having other viral syndromes, he has never felt this sick. Has gotten the flu before but has never gone on this long. He is just feeling like crap. Can barely even get out of bed every morning. It is unbelievable. He hasn't had any true positive exposure. Has not been exposed to other family members with Covid/ coronavirus. Have practices strict isolation in their home. They have 5 kids and they did not go near anyone or go to any public places. For this to happen, it has to be because of the vaccine. Nothing else could have caused this. No one else around him has been sick. Is not sure if they are getting a lot of reports. When going on line to the Pfizer vaccine reporting, it took him a while to get a number to contact Pfizer directly. He called (Withheld) and they gave him 2 wrong numbers. It took 4 people to get the number to report this to Pfizer. He thinks there is a lot of under reporting. If he has a deductible, he would like Pfizer to take care of the cost for his ER visit. On 21May2021, reported that Beginning 05/04 when received vaccine, experienced Very large lymph nodes and Flu syndrome. Outcome for events sore throat was recovered on May2021, for other events was unknown. The lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 51 | 2021-06-07 | pain in extremity |
Slight dizziness; a slight breathing difference; heart palpitations; soreness in arm and shoulders; ...
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Slight dizziness; a slight breathing difference; heart palpitations; soreness in arm and shoulders; soreness in arm and shoulders; tiredness; This is a spontaneous report from a non-contactable consumer (patient). A 51-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiration: not reported), via an unspecified route of administration, administered in arm right on 06Mar2021 10:45 as single dose for covid-19 immunisation (at the age of 51-year-old). The patient's medical history was none. Concomitant medication(s) included nortriptyline (as other medications in two weeks) taken for an unspecified indication, start and stop date were not reported. No other vaccine in four weeks, no covid tested post vaccination, no covid prior vaccination and no known allergies. Previously, the patient received first dose of PFIZER-BIONTECH COVID-19 VACCINE (Batch/Lot number and expiration was not reported), via an unspecified route of administration, administered in arm right on 13Feb2021 10:45 as single dose for Covid-19 immunisation (at the age of 51-year-old). On 06Mar2021 11:30, the patient experienced slight dizziness, a slight breathing difference and heart palpitations, and soreness in arm and shoulders, with tiredness. Not major issues but the patient thought should report them. No treatment taken. The outcome of all events was unknown. No follow-up attempts are possible; information about lot/batch number cannot been obtained.
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| 51 | 2021-06-09 | muscle spasms |
Extreme fatigue; Lower back pain is now moderate but currently ongoing; I had severe back spasms (lu...
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Extreme fatigue; Lower back pain is now moderate but currently ongoing; I had severe back spasms (lumbar region); Tightness in upper back; Hamstrings; This is a spontaneous report from a contactable (Patient). A 51-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN 6203 and Expiration Date not reported) via an unspecified route of administration, administered in left arm on 05Mar2021 at 01:45 PM as single dose for COVID-19 immunisation. The patient medical history included suspected allergy of penicillin and allergic to wasps. The patient not received other vaccine in four weeks. The patient concomitant medications included loratadine (CLARITIN) and omeprazole. The patient did not have COVID prior vaccination. On 06Mar2021 at 08:00 AM (18-hours after the vaccination), patient had severe back spasms (lumbar region) along with tightness in upper back and hamstrings, followed by extreme fatigue after 48 hour (morning of 07Mar2021) lasting until Tuesday (09Mar2021). Lower back pain was now moderate but currently ongoing. The patient visited doctor or other healthcare professional office/clinic as a result of events. The patient received treatment with Ibuprofen and Acetaminophen and electrolytes. The patient not tested for COVID post vaccination. On 09Mar2021, the extreme fatigue was resolved. The outcome of all other events was recovering. No follow-up attempts are possible. information about lot/batch number cannot been obtained.
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| 51 | 2021-06-10 | pain in extremity |
Pain in shoulders and elbows have persisted for over 2 months now. Range of motion of the right arm...
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Pain in shoulders and elbows have persisted for over 2 months now. Range of motion of the right arm in particular is limited significantly die to pain. There is dull to throbbing pain during certain times of the day even when arms are not being used. Pain becomes more intense if arms are moved in certain ways like reaching back or quick movements. Pain emanates from joints but seem to affect muscles of the upper arm as well.
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| 52 | 2021-01-03 | weakness, tremor |
Patient experienced shaking, nausea, vomiting, and diarrhea beginning the night of the immunization ...
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Patient experienced shaking, nausea, vomiting, and diarrhea beginning the night of the immunization (12.17.20). Patient had "extreme" fatigue and weakness for 2 weeks. Went to urgent care on 12.28.2020, no medications or treatment given. Resolved as of 1.4.21 with continued "slight" weakness. Patient also reports to have lost a considerable amount of weight.
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| 52 | 2021-01-04 | pain in extremity | DEVELOPED PAIN IN ARM AND NAUSEA |
| 52 | 2021-01-05 | muscle spasms | Moderate ankle pain left x 1.5 days Hamstring cramping moderate x 1 day Fatigue - moderate x 1 day |
| 52 | 2021-01-05 | pain in extremity |
Long bone aching pain, involving bilateral humeral bones and left femur. Pain began on day two and...
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Long bone aching pain, involving bilateral humeral bones and left femur. Pain began on day two and resolved on day five. I required two doses of ibuprofen to sleep on days three and four.
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| 52 | 2021-01-06 | discomfort |
Swollen under left armpit that irradiates to my arm, L+ right side of my chest and L+ neck side. It ...
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Swollen under left armpit that irradiates to my arm, L+ right side of my chest and L+ neck side. It caused pain and discomfort since last night.
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| 52 | 2021-01-06 | facial paralysis |
Patient developed left side Bell's Palsy 8 days after receiving vaccine. He was seen in the Emergenc...
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Patient developed left side Bell's Palsy 8 days after receiving vaccine. He was seen in the Emergency Department and started on Prednisone
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| 52 | 2021-01-06 | facial paralysis |
Patient developed Bell's Palsy on 1/1/2021 and was seen in the Emergency department and started on o...
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Patient developed Bell's Palsy on 1/1/2021 and was seen in the Emergency department and started on oral steroids. I saw him 1/6/2021 and he continued to have left sided facial nerve palsy/paralysis.
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| 52 | 2021-01-06 | numbness |
Date and time of vaccination: 12/17/21 19:30 Age at vaccination 52Y 10M Adverse symptoms: - Visual m...
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Date and time of vaccination: 12/17/21 19:30 Age at vaccination 52Y 10M Adverse symptoms: - Visual migraines 12/19,12/20,12/21 with loss of vision/aura for about 30m-1h, mild headache followed. -numbness, intermittent in left ring and pinky finger 12/19,12/20,12/21
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| 52 | 2021-01-06 | numbness | BlurredVision, UrticariaPruritus, numness face and tongue |
| 52 | 2021-01-07 | discomfort |
Dizziness & HYPERtension Narrative: Patient reports light headedness, dizziness, "heavy" feeling to ...
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Dizziness & HYPERtension Narrative: Patient reports light headedness, dizziness, "heavy" feeling to monitoring staff. Patient given some water and monitored for 30 minutes by monitoring staff. BP 139/111 HR 75, recheck BP 141/99 HR 80 reported to this RN. Event reported to this RN at 1350, patient returned to workstation.
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| 52 | 2021-01-07 | difficulty speaking | The Patient present Sore throat , cough ,hoarseness . the doctor gave him Benadryl 50 mg IM now |
| 52 | 2021-01-07 | muscle twitching |
Patient spoke to me this morning regarding some symptoms he had after his Pfizer COVID 19 vaccinatio...
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Patient spoke to me this morning regarding some symptoms he had after his Pfizer COVID 19 vaccination yesterday. He said he had some pain at the injection site and mild headache in the afternoon; however, around 12 to 1 am in the morning, he was feeling heart palpitation and he felt his muscle twitching from his upper torso which went down to his thigh and no loss of consciousness. He said he checked his heart rate and it was 70 and he did not have any problems breathing. He said his heart palpitation felt better after taking some deep breaths. He said he no longer had heart palpitations or muscle twitching any more. He denied any other symptoms. Generally, he appeared well, no facial drooping, awake, alert, oriented, speech clear, and normal gait. (Today)
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| 52 | 2021-01-07 | pain in extremity |
covid 19 test result came up positive; covid 19 test result came up positive; severe left arm pain; ...
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covid 19 test result came up positive; covid 19 test result came up positive; severe left arm pain; This is a spontaneous report from a contactable unspecified Healthcare professional reporting for himself. This 52-year-old male patient received on 20Dec2020 02:30 PM first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EK5730) at single dose intramuscular in the left arm for COVID-19 immunization. No allergies to medications, food, or other products. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID 19. Concomitant medications (all started on an unknown date and received within 2 weeks of vaccination) included buspirone hydrochloride (BUSPIRON), atorvastatin (manufacturer unknown) and acetylsalicylic acid (BABY ASPIRIN). On 21Dec2020, 10 hours after getting vaccine the patient had body aches, cold and severe left arm pain. 4 days after getting vaccine again the patient had cold, body aches and sore throat for couple of days. On 28Dec2020, covid 19 test (nasal swab) result came up positive. The patient went to Emergency room. Outcome was recovered on an unknown date. It was unknown if a treatment was performed.; Sender's Comments: The association between the event lack of effect (COVID 19 nasal swab test result came up positive) with BNT162b2 can not be fully excluded.
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| 52 | 2021-01-09 | weakness | General body aches, lost of appetite, general weakness, painful vaccination site |
| 52 | 2021-01-11 | pain in extremity |
body ache; Headache; soreness in his arm; This is a spontaneous report from a Pfizer-sponsored progr...
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body ache; Headache; soreness in his arm; This is a spontaneous report from a Pfizer-sponsored program from a contactable physician reported for himself. A 52-year-old male patient intramuscularly received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EK5730), first dose on 15Dec2020 21:00 and second dose on 05Jan2021 09:00 at single dose at deltoid left for preventative. Medical history and concomitant medications were reported as none. The patient experienced body ache on 06Jan2021 with outcome of unknown, soreness in his arm on 05Jan2021 with outcome of recovering, headache on 06Jan2021 with outcome of not recovered. He was asking if he can take paracetamol (TYLENOL) for body ache and soreness in his arm following administration.
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| 52 | 2021-01-12 | tingling |
About 10minutes post vaccine, he started c/o tingling to the right side of his neck and radiating do...
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About 10minutes post vaccine, he started c/o tingling to the right side of his neck and radiating down to his fingers. Vital signs were stable: BP 129/87, 97% RA, temp 97, HR 75, respirations 20, denies pain. Also c/o sweating palms, nausea but no emesis, mild dizziness, no SOB/difficulty breathing. Stated he did not eat anything this morning. Provided with crackers and water. At 0839, re-evaluated, nausea improved VS 132/88, hr 73, 98% RA, denies pain, continues to have tingling but not worsening, sweaty palms improving. At 0905 tingling and nausea have improved no longer c/o dizziness, vs 130/95, hr 81, 98% RA, RR 18, denies pain. Felt good to go home. Total time of about 30 minutes wait.
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| 52 | 2021-01-13 | pain in extremity |
soreness in my arm; This is a spontaneous report from a contactable nurse (patient). A 52-year-old m...
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soreness in my arm; This is a spontaneous report from a contactable nurse (patient). A 52-year-old male patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number: EH9899; expiration date: not known), via an unspecified route of administration on left arm on 15Dec2020 at single dose for covid-19 immunization, administered at hospital. Medical history included idiopathic epilepsy. The patient's concomitant medications were not reported. With first dose, the patient experienced soreness in his arm with no other symptoms on an unspecified date. The outcome of the reported event soreness in his arm was unknown. On 06Jan2021 10:45, the patient received second dose of vaccine. On 06Jan2021 at 17:00, the patient had fatigue two days after as well lymph node swelling in armpit of arm where second dose administered.
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| 52 | 2021-01-14 | tremor |
fever went up 99.9; woke up covered in sweat; shaking so bad; shivering; had trouble keeping balance...
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fever went up 99.9; woke up covered in sweat; shaking so bad; shivering; had trouble keeping balance; swaying when walking; felt like crap; This is a spontaneous report from a contactable consumer. A 52-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Dec2020 at a single dose SINGLE DOSE for COVID-19 immunization. Medical history included COVID-19 in Apr2020. The patient's concomitant medications included celecoxib (CELEBREX). After receiving the vaccine fever went up 99.9, woke up covered in sweat, shaking so bad, shivering, had trouble keeping balance, was swaying when he was walking on an unspecified date. The patient also stated he felt ill for 3-4 days. The outcome of the events was unknown. Information about lot/batch number has been requested.
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| 52 | 2021-01-15 | flushing |
Flushing, possible rash/hives, vision changes. Allergy medication given at test site. Transported ...
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Flushing, possible rash/hives, vision changes. Allergy medication given at test site. Transported to ER for observation. Given Decadron and Pepcid. Observed and discharged.
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| 52 | 2021-01-18 | flushing |
EE woke up on 12/22/2020 experiencing diarrhea, facial flushing and swelling, lip/brow swelling, han...
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EE woke up on 12/22/2020 experiencing diarrhea, facial flushing and swelling, lip/brow swelling, hands started swelling, edema, redness/rash. Patient was evaluated at local EC and was found to have low BP. EE was treated with Solumedrol, Benadryl, and Pepcid. Patient was discharged home from EC after 2 hours with PO steroids x4 days.
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| 52 | 2021-01-18 | pain in extremity | Pain and weakness to left leg, causing drop foot. |
| 52 | 2021-01-19 | pain in extremity |
Soreness in arm about 8 hours later; December 26 I started to have congestion, and headache and litt...
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Soreness in arm about 8 hours later; December 26 I started to have congestion, and headache and little bit of a cough. Some body aches, loss of taste and smell, as well. 27th - Covid test - Pos-tive (notified on 28th). Symptoms lasted for about 7 days except loss of taste and smell was only 5 days and it resolved. Took Tylenol and Mucinex D. Went to Urgent Care. Still having lingering congestion and fatigue.
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| 52 | 2021-01-19 | tenderness |
Approximately 4-5 hours after the injection, my right elbow began hurting. There is no swelling o...
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Approximately 4-5 hours after the injection, my right elbow began hurting. There is no swelling or injury. The elbow is a burning pain. It hurts to even touch my elbow!
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| 52 | 2021-01-20 | pain in extremity, numbness, cold extremities |
Patient states he had mild to moderate discomfort in my L arm (injection location), it has continued...
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Patient states he had mild to moderate discomfort in my L arm (injection location), it has continued for approximately 12hrs, along with my hands feeling numb and cold, patient also felt a bit lightheaded.
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| 52 | 2021-01-20 | tingling, feeling hot |
approximately 5 mins after vaccine administration patient felt itching, tickling feeling, and warmth...
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approximately 5 mins after vaccine administration patient felt itching, tickling feeling, and warmth on her abdomen around her naval area. Patient monitored for full 30 mins. Redness decreasing, itching & tickling resolved by discharge at 1140. MD discussed OTC Benadryl use.
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| 52 | 2021-01-20 | tremor, cold sweat | Cold sweats, shaking, headache, congestion., joint soreness, muscle soreness |
| 52 | 2021-01-24 | feeling hot, hot flush |
sick; With the first dose he got tired and had malaise, and body aches for two days; With the first ...
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sick; With the first dose he got tired and had malaise, and body aches for two days; With the first dose he got tired and had malaise, and body aches for two days; With the first dose he got tired and had malaise, and body aches for two days; felt warmth in the arm; hot flash; just got really hot; This is a spontaneous report from a contactable consumer (patient himself). This 52-year-old male received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number ELO140), via an unknown route, on 23Dec2020 (at 06:00 AM), at single dose in the left upper arm on 23Dec2020 for COVID-19 immunization, administered at hospital. The patient had COVID-19 from 17Jul2020 to 14Aug2020 for which he was not hospitalized but he was pretty sick and had circulations issues; he had a little of numbing and tingling in his left three fingers after COVID virus. The patient clarified left three fingers as his middle finger, index finger, and ring finger. He had numbing and tingling in his toes as well. Relevant concomitant medications included ubidecarenone (COQ-10), rosuvastatin calcium (CRESTOR OD), monascus purpureus (RED YEAST RICE PLUS), and acetylsalicylic acid (BABY ASPIRIN). With the first dose he got tired and had malaise, and body aches for two days: He got the vaccine after working that night (He works in the intensive care unit). He got it at 6:00 AM. He felt warmth in the arm. It went all the way down the left arm. He got a hot flash. He stayed there for 15 minutes and was fine, but just got really hot. He finished his shift and didn't have any other reactions. He went to sleep and woke up in the afternoon on the 23Dec2020 and went to work. He didn't feel anything at that time. He was working six or seven days in a row. When he was working that night was when he started feeling body aches and fatigue. He didn't even put two and two together that it was from the vaccine. He felt like he needed to take something. His body temp was normally 97 and when he checked it was 98. He took a little ibuprofen (MOTRIN) and felt a lot better after taking it. He slept when he got home and had body aches and fatigue for a couple of days. He cancelled going away for a couple of days. By noon on 25Dec2020 he was feeling like he was getting back to normal. He continued to lay around all day and didn't do much. He was sick with the first and was expecting to be more sick with this one. He wanted to give himself an extra day before he had to go back to work. The patient had recovered from the event 'with the first dose he got tired and had malaise, and body aches for two days' on 25Dec2020 while the outcome of the remaining events was unknown.
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| 52 | 2021-01-24 | pain in extremity |
received shot in left arm, the next day my left arm, neck and upper back were sore, the next day I h...
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received shot in left arm, the next day my left arm, neck and upper back were sore, the next day I had aching pain radiating through my right shoulder and down my right arm. and getting worse. Seems my neck/upper back pain may have pinched nerve and is causing this.
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| 52 | 2021-01-25 | weakness |
his brain was still a little cloudy; tested positive for covid; tested positive for covid; lost 10 p...
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his brain was still a little cloudy; tested positive for covid; tested positive for covid; lost 10 pounds; energy level changed drastically; weak; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot no: EH9899, via an unspecified route of administration in left arm on 21Dec2020 09:00 at a single dose for COVID-19 immunization in a hospital. Medical history included hypertensive and diabetic, both ongoing. Concomitant medication included metformin for diabetic and olmesartan medoxomil (BENICAR) for hypertensive. There were no prior vaccinations within 4 weeks. The patient received the covid vaccine first dose on 21Dec2020 and started developing covid symptoms on the 27Dec2020. He was tested positive for covid on the 28Dec2020. The patient wanted to know what is next. He patient stated that it has been 10 days and he wanted to know if he is still contagious. He is scheduled to get the second dose on 11Jan2021. He wonders if he can get the second dose or does have to start the process over again. He works in a doctor's office. He is a technician. While providing height and weight he commented it has changed drastically. He later clarified it was his weight that changed drastically. He lost ten pounds. His weight and energy level changed drastically, and this was after getting the COVID Vaccine. His symptoms started the weekend after taking the vaccine. He had COVID symptoms. He later clarified and stated they all started on 27Dec2020. He clarified his symptoms as: body aches and fever. The body aches and fever started the night of 27Dec2020 and recovered from 08Jan2021. He was unable to provide an exact time of onset. These have resolved, but at the time of report he was just weak. He had a COVID test done on 28Dec2020 he tested positive. He confirmed he has not had a follow-up COVID test done afterwards. The patient also mentioned that his brain was still a little cloudy since an unspecified date. The patient had not recovered from the event weak; while outcome of "lost ten pounds", "his brain was little cloudy" and "tested positive for covid" was unknown.
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| 52 | 2021-01-26 | tingling |
4hrs after vaccine mild right arm hand Parasthesias in a radial distribution. These have persisted....
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4hrs after vaccine mild right arm hand Parasthesias in a radial distribution. These have persisted. Same eve mild facial Parasthesias. This has progressed Now primarily left sided and have objective fasiculations and tongue deviation. Also mostly left lower leg Parasthesias. Some right.
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| 52 | 2021-01-26 | tremor |
he got real cold and shaky and couldn't get warm; he got real cold and shaky and couldn't get warm; ...
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he got real cold and shaky and couldn't get warm; he got real cold and shaky and couldn't get warm; temperature was low at 96 degrees Fahrenheit; He got nauseous with it; He had severe fatigue; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ELO140) via an unspecified route of administration on left arm on 11Jan2021 at 9:15 at single dose for COVID-19 immunization. The relevant medical history included Covid-19 from 17Jul2020 to 14Aug2020, he didn't get hospitalized but was pretty sick. He had circulation issues with it. He had numbing and tingling in his left three fingers (clarified left three fingers as his middle finger, index finger, and ring finger) and numbing and tingling in his toes as well. Concomitant medications included ubidecarenone (COQ-10), acetylsalicylic acid (BABY ASPIRIN), rosuvastatin and monascus purpureus (RED YEAST RICE). The patient previously received the first dose of BNT162B2 at the age of 52 years old on 23Dec2020 at single dose for COVID-19 immunization. With second dose the patient thought he would be better, but about 12 hours later he got real cold and shaky and couldn't get warm. He checked his body temperature and he didn't have a temp. His temperature was low at 96 degrees Fahrenheit. He tried to keep himself warm. He got nauseous with it. Basically he looked on line and was having them. Today he started to feel better, but still a little nauseous. He had severe fatigue. He didn't realize he could go fill out something on the website for CDC. He knew he had wanted the vaccine because he had some severe symptoms when he had COVID. He didn't want to get COVID again. His hospital frustrates him sometimes. They didn't put the date on there when he was to come back for the second dose. They didn't tell him to come back on the 13th. He had to figure the dates from the website and emails. He talked it over with his wife. He came in contact with it every night. He was taking care of people that were critical. He worked in the intensive care unit. Even the people he took care of that didn't have it, ended up with it. He wore a mask. He used hand sanitizer. He didn't want to get it again. People were shocked when he got it the first time. He did verify that he got the second dose one day sooner, instead of the three day window. He was sick with the first and was expecting to be more sick with this one. He wanted to give himself an extra day before he had to go back to work. He had a couple of emails where they discussed increasing the window to do it a day sooner. He was going to have to go an hour an half a way to get the second dose and he didn't want to do that. The patient underwent lab test included height was approximately six two, weight was about 194 lbs on an unspecified date, and body temperature showed 96 degrees Fahrenheit in Jan2021. The outcome of the event he got real cold and shaky and couldn't get warm, temperature was low at 96 degrees Fahrenheit was recovering, for the events he got nauseous with it and he had severe fatigue were not recovered.
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| 52 | 2021-01-27 | weakness |
generalized itching, maculopapular rash, lips, face, neck, tongue swelling, difficulty of swallowin...
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generalized itching, maculopapular rash, lips, face, neck, tongue swelling, difficulty of swallowing, left wrist swelling, generalized weakness, fatigue. 2nd dose of vaccine received on 01/11/21, first was on 12/22/20. Symptoms started on 01/16/21 between 1 and 2 am. First day symptoms were mild resolved after taking allegra and benadryl. On 01/17/21 between 2 and 3 am started again, and got worse, did not improve after taking allerga and zyrtec. Later in the day started on prednisone daily, allegra daily and one dose of benadryl. Symptoms lasted for few more days
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| 52 | 2021-01-29 | hot flush | Mild nausea, muscle/body aches, and hot flashes for 12 hours |
| 52 | 2021-02-01 | bell's palsy |
Bells Palsy after 2nd dose given on Jan 27th. Onset that Friday night with full effects of BP that S...
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Bells Palsy after 2nd dose given on Jan 27th. Onset that Friday night with full effects of BP that Saturday
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| 52 | 2021-02-05 | bell's palsy, facial paralysis | Loss of muscle control on one side of my face, diagnosed as Bell's Palsy. |
| 52 | 2021-02-06 | sensory loss |
2 weeks after my second shot, I had a CVA causing complete loss of sensation in my left arm. I am i...
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2 weeks after my second shot, I had a CVA causing complete loss of sensation in my left arm. I am in good health and do not have multiple risk factors for CVA. While the scans showed evidence of a CVA, no underlying cause has yet to be determined.
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| 52 | 2021-02-07 | weakness |
Severe insomnia over the past 8 weeks, unrelenting. Start exactly at 24 to 48 hours after vaccine. H...
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Severe insomnia over the past 8 weeks, unrelenting. Start exactly at 24 to 48 hours after vaccine. Had no previous illnesses before that. No history of Covid infection. Has done all sorts of CBT modifications with no improvement. Was previously a super high functioning Interventional Cardiologist with no prior history of anxiety, depression or sleep problems. This was very acute and worsened after second dose. Labs are all normal. Now unable to work as this insomnia is quite debilitating.
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| 52 | 2021-02-07 | seizure |
Vaccine administered on 1/19/21 at 2:15pm and patient began having seizure activity on 1/20/21 at ap...
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Vaccine administered on 1/19/21 at 2:15pm and patient began having seizure activity on 1/20/21 at approximately 4pm Patient sent to ER for evaluation. Temperature of 102 was noted at ER. Seizure eventually resolved and he returned to his residence. He has a prior history of seizures.
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| 52 | 2021-02-09 | weakness |
energy level was throught the roof; energy level was throught the roof; no energy and was unable to ...
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energy level was throught the roof; energy level was throught the roof; no energy and was unable to get out of bed; felt really weak; Appetite lost; Pain; left shoulder felt heavy with first dose; This is a spontaneous report from a contactable consumer. A 52-years-old male patient started to receive bnt162b2 (BNT162B2) Lot# EL1686 via an unspecified route of administration on 03Jan2021 16:00 1 dose at SINGLE DOSE for covid-19 immunisation. Vaccination Facility Type: Nursing Home. Anatomical Location of vaccine left arm. Medical history included diabetes mellitus from Nov2020 and ongoing. Concomitant medication included glipizide (GLIPIZIDE), metformin (METFORMIN). The patient experienced left shoulder felt heavy with first dose on 03Jan2021 with outcome of recovered, pain on 06Jan2021 with outcome of recovered felt really weak on 07Jan2021 with outcome of recovered, appetite lost on 07Jan2021 with outcome of recovered, no energy and was unable to get out of bed on 08Jan2021 with outcome of recovered, energy level was through the roof on 15Jan2021 with outcome of not recovered. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 24Jan2021. The reporter stated "Following the first dose his left shoulder felt heavy. On 06Jan2021 he had pain. It was in his waist. It was constant and was on both sides of his waist. On 07Jan2021 the pain moved from his waist to between his shoulder blades. It was like that for the whole day. He also felt really weak. He was unable to keep his upper body up. He struggled all day while at work. He thought he had Covid but was tested and the result was negative. The pain became worse and moved from his spinal cord to his head. This caused him to miss work. He did not have any energy and was unable to get out of bed. He also lost his appetite. Then on 15Jan2021 his energy level was through the roof like he was on steroids" The action taken was not applicable.
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| 52 | 2021-02-10 | weakness |
Severe lip swelling; Body rash; Chills, rigors; Muscle aches; Nausea; Generalized weakness; This is ...
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Severe lip swelling; Body rash; Chills, rigors; Muscle aches; Nausea; Generalized weakness; This is a spontaneous report from a contactable physician (patient). A 52-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration Arm Left on 11Jan2021 at 01:00 PM as a single dose for COVID-19 immunisation, lot number: EK5730. Medical history and concomitant medications were not provided. Patient had no known allergies. Patient received first vaccine dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Dec2020 at Left arm for COVID-19 immunisation, lot number: ELO142. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 14Jan2021 at 04:00 PM patient experienced severe lip swelling, body rash, chills, rigors, muscle aches, nausea, generalized weakness. The events were treated with fexofenadine hydrochloride (ALLEGRA), diphenhydramine hydrochloride (BENADRYL) and presnosone. Events resulted in Doctor or other healthcare professional office/clinic visit. Patient had not tested for COVID-19 since having the vaccine. Patient was recovering from the events, at the time of the report.
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| 52 | 2021-02-10 | nerve pain, pain in extremity |
Symptoms - ?Patient reports immediately after injection really bad arm pain and described as ?nerve ...
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Symptoms - ?Patient reports immediately after injection really bad arm pain and described as ?nerve pain, stinging in nature.? Patient verbalizing concerns with injection technique by vaccine administrator. Patient reports he didn?t think anything of it and worked night shift (7p-7a) on 1/10, 1/11, 1/12 without improvement. Patient reports he worked on 1/19, 1/20, 1/21 and Patient reports pain to R scapula. Patient reports he used Acetaminophen; Ibuprofen and muscle rub without relief. Patient notified EH and had appointment with PA on 2/1. Patient reports he has been receiving PT at TCH twice/weekly. Patient reports he was prescribed Gabapentin and reports significant relief. Patient had f/u appointment today (2/11) with PA and was notified to contact us to report adverse reaction. EE reports he was told by PA to contact ?occupational health? for more assistance. Patient notified vaccine support line is for adverse reactions to vaccine and Patient verbalized he was unsure who he was supposed to contact. Patient notified to contact PA directly as he is under his care and ask for the contact phone number/email of who he needs to contact next. patient reports next f/u appointment scheduled with EH on March 4th. Patient verbalized back understanding and denied further questions at this time. Last day of work and shift - unknown, Patient did not disclose. Home remedies? - see ?symptoms? for detailed account Any improvement? - yes Recommendation? Patient educated to continue to follow instructions provided by PA at EH as he is under his medical care. Patienteducated to contact PA at EH with further questions or concerns regarding management of care.
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| 52 | 2021-02-11 | feeling hot |
Warm risk throughout body, similar to contrast in a CT scan. Lasted 3 minutes. Had mild body aches n...
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Warm risk throughout body, similar to contrast in a CT scan. Lasted 3 minutes. Had mild body aches next day.
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| 52 | 2021-02-11 | seizure like phenomena |
*Please note it is not known if event was related to vaccine* On 2/10/2021, at approximately 5:30 A...
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*Please note it is not known if event was related to vaccine* On 2/10/2021, at approximately 5:30 AM, patient began to experience dizziness and shortness of breath. Per witnesses, he then began to have seizure activity followed by cardiac arrest. He was treated with CPR and 1 shock from the AED, which resulted in spontaneous return of circulation. He was awake and confused after return of pulse and sent to Hospital Emergency Room. This event occurred 19 days post first vaccine. He was scheduled to get his second dose on 2/12/2021, but did not receive it due to event.
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| 52 | 2021-02-16 | night sweats |
On 1/18 developed fever 102.5, upon waking, around 8am. Fever climbed to 103.5 in the afternoon. Ac...
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On 1/18 developed fever 102.5, upon waking, around 8am. Fever climbed to 103.5 in the afternoon. Acetaminophen 1000mg taken and fever dropped to 102.5 in evening of 1/18. Severe night sweats and chills at night of 1/18 and 1/19, 1/20. Was advised by employer to go to ED due to elevated fever >12hrs. Pt declined due to cost of ED visit.
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| 52 | 2021-02-18 | burning sensation, nerve pain |
1. during the administration, it burned really bad 2. progressive more pain, (muscle) soreness sta...
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1. during the administration, it burned really bad 2. progressive more pain, (muscle) soreness starting about 10 days after shot--steadily increasing shoulder, trapzius, neck pain/stiffness 3. after conventional at home treatment for sore muscles for 2 weeks, I saw PA at employee health (25 days after injection) 4. at the time of visit, (Feb 01) I was in the most pain
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| 52 | 2021-02-18 | nerve pain |
Around noon on 1/29/21 (less than 24 hours after the shot) i felt a weird nerve sensation throughout...
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Around noon on 1/29/21 (less than 24 hours after the shot) i felt a weird nerve sensation throughout my entire body. The only way to describe it is the nerve pain you feel when you hit your funny bone. That was the sensation I was feeling throughout the body. There was also intense bone pain and lower back pain. These were also the same symptoms I had when I had a mild case of covid 3/2020 and didn?t know I had it. In June 2020 I tested positive for antibodies.
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| 52 | 2021-02-19 | pain in extremity | muscle and arm soreness for 4 days |
| 52 | 2021-02-19 | unresponsive to stimuli, tremor, seizure, flushing |
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unrespo...
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Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Severe, Systemic: Seizure-Medium, Systemic: Shakiness-Severe, Additional Details: About 5 minutes after receiving vaccine, patient was seated in observation area and notified facility staff member who was in charge of observing patients that he felt faint. Staff member reported patient quickly turned extremely red and was showing seizure-like activity, unconscios. She alerted the pharmacists to come over I came over and patient appeared bright red, pupils extremely dilated and was not conscious, grabbed pt arm he woke up and then showed typical vasovagal symptoms thereafter.
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| 52 | 2021-02-21 | pain in extremity, weakness |
Slightly sore arm for a day. Starting ten hours and lasting maybe thirty hours was a series of inten...
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Slightly sore arm for a day. Starting ten hours and lasting maybe thirty hours was a series of intense chills and strong, flu=like weakness. From about 24 hours for maybe the next 4 days, significant aggravation of legacy rashes from my chronic skin conditions. After 4 days, they reverted to normal.
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| 52 | 2021-02-25 | bell's palsy | reoccurrence of left bell's palsy |
| 52 | 2021-02-25 | numbness | NUMBNESS ON LEFT SIDE OF BODY, CRYING, "LOOKS" DIFFERENT |
| 52 | 2021-02-26 | bell's palsy |
Pt states he developed Bell's palsy two weeks after his first Covid vaccine. He states he saw his P...
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Pt states he developed Bell's palsy two weeks after his first Covid vaccine. He states he saw his PCP. His PCP recommended he still get the second injection-but to put it off as long as possible. Pt said the symptoms from Bell's Palsy have entirely resolved.
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| 52 | 2021-02-26 | hot flush |
Left jaw pain & soreness near left ear (difficult to open mouth, chew food) from 7 am day after inje...
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Left jaw pain & soreness near left ear (difficult to open mouth, chew food) from 7 am day after injection (current as of 10pm, same day), mild nasal congestion (starting around 6pm day after injection, current as of 10pm), chills (lasted about an hour 6-7pm day after injection), flush (about an hour after chills ended). AM temp 97.7 (9 AM), PM temp 101.1 (10 PM).
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| 52 | 2021-02-28 | facial pain |
Fever; Chills; Body Ache; Pain in face; Pain in back; pain in hip; Headache for 2 days; Vivid nightm...
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Fever; Chills; Body Ache; Pain in face; Pain in back; pain in hip; Headache for 2 days; Vivid nightmares; Sweats; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received the first dose of BNT162B2 (BNT162B2, Solution for injection, lot number: EL3249, expiry date: not reported), via an unspecified route of administration, on 25Jan2021 03:00 PM at a single dose on the left arm for COVID-19 immunization. The vaccine was administered at a hospital. Medical history was none. The patient was not diagnosed with covid prior to vaccination. He had no known allergies. Concomitant medications were not reported. On 26Jan2021 01:15 AM, the patient experienced fever, chills, sweats, body ache, pain in face, pain in back, pain in hip, headache for 2 days, vivid nightmares. 2 days later (at the time of report, 27Jan2021), the patient still had low grade fever, sweating, body ache and headache. No treatment was received for the reported adverse events. Outcome of the events was reported to be recovering. The patient was not tested for covid post vaccination.
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| 52 | 2021-02-28 | tingling |
Patient noted tingling to throat, mouth and nose, he was monitored in parking lot for 30 mins but st...
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Patient noted tingling to throat, mouth and nose, he was monitored in parking lot for 30 mins but still had some tingling in nose. Advised Benadryl, he was agreeable,. He was monitored thereafter for 15 mins. Insisted on going home, he was alone, risks discussed. Noted he was going straight home, where wife and mother could monitor him.
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| 52 | 2021-03-02 | difficulty speaking |
35 Minutes after receiving vaccine, itching on head, then body and face, including welt on chest, hi...
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35 Minutes after receiving vaccine, itching on head, then body and face, including welt on chest, hives. 50 minutes later eye itchiness and swelling in left eye, throat felt weird (swelling), dizziness, change in voice, wheezing (not severe, but could tell breathing was more restricted than before shot). Almost went to ER, but symptoms subsided without any medication in 2 hours. Did not go to hospital or ER.
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| 52 | 2021-03-05 | numbness |
Heart fluttering/skipping beats shortly after receiving and periodically continuing up to this date....
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Heart fluttering/skipping beats shortly after receiving and periodically continuing up to this date. Numbness feeling in face and jaw several hours after receiving that continues today. Feel pressure on forehead and nostril area.
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| 52 | 2021-03-07 | weakness |
Goosebumps tingly sensation in head; Blood pressure and palpitation/heart rate/heartbeat is getting ...
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Goosebumps tingly sensation in head; Blood pressure and palpitation/heart rate/heartbeat is getting higher and higher.; Blood pressure and palpitation/heart rate/heartbeat is getting higher and higher.; feeling weak; Heaviness in the head; Feeling anxiousness in the brain; Localized soreness and pain; This is a spontaneous report from a contactable consumer reported for himself. A 52-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 24Jan2021 18:00 (Lot number: EL9263) via unspecified route of administration in the left upper arm at SINGLE DOSE for COVID-19 Immunization. The patient's medical history included ongoing diabetes (Due to diabetes has low testosterone), High cholesterol both from 2005, Colitis ulcerative from 1999, Glaucoma from 2010, Enlarged prostate gland from 2018 and Chronic sinus infection, Acid reflux and GERD from an unknown date and unknown if ongoing. The concomitant medication included Janumet (Metformin hydrochloride/sitagliptin) ongoing for diabetes mellitus at (50/1000 one tablet twice daily), amoxil (amoxicillin) for low testosterone via topical route at 4 pumps, azelastine at two sprays twice a day for chronic sinus infection, crestor (rosuvastatin calcium) ongoing at 5 mg once a day blood cholesterol increased, tamsulosin ongoing at 0.4mg once a day for enlarged prostate gland, dexilant (dexlansoprazole) at 30 mg once a day for acid reflux and GERD, lialda (mesalazine) ongoing at 4.8 mg, once a day (1.2gram 4 tablets once a day) for colitis ulcerative, canasa (mesalazine) ongoing 1 g once a day (at night time) for colitis ulcerative, timolol ongoing at one drop both eyes at once a day for glaucoma, lumigan (bimatoprost) ongoing for at one drop both eyes once a day for glaucoma, melatonin ongoing at 5mg once a day for insomnia, zyrtec (cetirizine hydrochloride) ongoing at 10 mg (on of them) for insomnia, xanax (alprazolam) 1 mg at 1mg at night time and 1 mg as needed for generalized anxiety and blood pressure, 5-hydroxytryptophan ongoing at 100mg for anxiety, carvedilol ongoing at 25 mg, once a day (12.5mg in the morning 12.5 at night) for blood pressure measurement, valsartan ongoing at 160 mg, once a day (160mg one tablet once day in the morning) for blood pressure measurement, hydrochlorothiazide tablet ongoing at 12.5 mg, once a day for blood pressure measurement, Vitamin E at 400 international units; one capsule once a day, ongoing ambozil for low testeterone, clonidine ongoing at 0.1 mg as needed for blood pressure measurement. History of all previous immunization with the Pfizer vaccine considered as suspect: None, this was the first dose. No other vaccine administered on the same date. The patient had no events prior vaccination within 4 weeks. In all his life. He had vaccines that received and had no adverse event or side effect whatsoever. He had had the regular flu vaccine early November. The patient experienced feeling anxiousness in the brain, Heaviness in the head, feeling weak in Feb2021, Localized soreness and pain in Jan2021, Goosebumps tingly sensation in head, Blood pressure and palpitation/heart rate/heartbeat is getting higher and higher on 04Feb2021. The patient could not take Benadryl as he cannot tolerate Benadryl. With Zyterc he does not have secondary effects like he does with Benadryl. The first week after getting the vaccine he only had kind of had localized soreness and pain in the area. He later clarified it was in the area where got the injection, vaccine. He just had pain soreness in that area. Other than that he had no side effects at that time. The third week, initially stated as, about 5-7 days ago he started to have a feeling of anxiousness in the brain. He could feel anxiousness and sensation in his brain that he did not feel before. It was like he had the flu kind of thing, but he did not have a temperature. However, the feeling is in his head. It is like heaviness feeling from the flu in his head. He has been having the heaviness in the head feeling for 4-5 days. He later further clarified and initially clarified the localized pain and soreness was noticed the second day, the day after getting the vaccine. This only lasted a few days. He does not remember exactly when this ended. He did not take anything for the localized pain and soreness in the same area as the injection. He confirmed he has recovered completely from this event. Caller further clarified the feeling of anxiousness started Thursday or Friday of last week, maybe 05Feb2021. Stated it was like this feeling is getting worse and worse. Stated it was hard to explain, but he started to feel a goosebumps tingly sensation in his brain in head, in scalp Thursday of last week first. It started with that and slowly over the past few days it has changed and transformed into this heaviness feeling that one would feel from the flu, but he has no fever or anything; it is just in his head. Also, along with that feeling at the same time his blood pressure and palpitation/heart rate/heartbeat was getting higher and higher. His regular blood pressure medications won't work anymore to bring it down. His blood pressure typically ranges in the 130/85 or less range with all the blood pressure medications he was taking. Once he started having this tingling sensation in his head he had the higher blood pressure and higher heart rate. Now his blood pressure would average being about 170/110 to 180/115. This was like the upper and lower range. His heart rate was typically around 70-75 and now it goes about 80-85. Later during call, he also added, every six months or so his blood pressure may be elevated on these medications. Sometimes his blood pressure was not maintained by the three different blood pressure medications he takes. He was also prescribed two other medications for emergent use Clonidine and Xanax. Usually every six months he would have to take Clonidine and Xanax and typically in an hour to two hours the blood pressure would come down and it's good. However, this time, he took two Clonidine and Xanax starting last Thursday when had the high blood pressure episode and they were failing to bring the blood pressure down. He further explained it would bring it down for some time, but then it would go back high. The Clonidine is no longer working for the last six days. When probed for labs/testing he sated he could not work anymore due to the events reported. He was feeling weak. He could not really walk. He took time off from work. He went to see his primary care provider on Monday. On Monday the doctor doubled the dose of Carvedilol. Since then instead of taking 12.5 twice a day, he is now taking 25mg twice a day. On Tuesday, yesterday, he went to get blood work done. Blood was drawn but has no results yet. Localized pain and soreness time of onset didn't remember, stated he may have had a little pain right after getting the vaccine, but it was around 21:00 25Jan2021 he really noticed the soreness and pain. The following morning around 9 AM it woke him from his sleep and he could feel it more compared to the first day. Anxiousness in the brain around 16:00. The patient had no emergency visit. Stated he almost felt like going when his blood pressure was 182/116 on Saturday night of last week. He was about to go to the ER but decided not to. He ended up taking two Clonidine and one Xanax, laid down, and eventually his blood pressure came down a little. Therefore, he did not go. The patient had physicians office visit. After getting the vaccine he mentioned started to have a feeling of anxiousness in the brain that was getting worse. He could feel anxiousness and sensation in his brain that he did not feel before. Also, his blood pressure and palpitation/heart rate/heartbeat was getting higher and higher. His regular blood pressure medications won't work anymore to bring it down. Later during call, he also added, every six months or so his blood pressure may be elevated on these medications. Sometimes his blood pressure was not maintained by the three different blood pressure medications he takes. He was also prescribed two other medications for emergent use Clonidine and Xanax. Clonidine: 0.1mg only during times he has episodes of high blood pressure. Usually every six months he would have to take Clonidine and Xanax and typically in an hour to two hours the blood pressure would come down and it's good. However, this time, he took two Clonidine and Xanax starting last Thursday when had the high blood pressure episode and they were failing to bring the blood pressure down. It would bring it down for some time, but then it would go back high. The Clonidine was no longer working. The patient experienced side effects on the 3rd week after getting vaccinated and had already made a report. The patient's second dose was scheduled for 21Feb2021 which was 28 days after the first dose. The outcome of the event Feeling anxiousness in the brain was not recovered, Localized soreness and pain recovered in 2021 and outcome of other events was unknown. No follow-up attempts are possible. No further information is expected.;
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| 52 | 2021-03-07 | weakness | light fever, aches, muscles sore, loss of energy |
| 52 | 2021-03-07 | tenderness, pain in extremity |
Extreme Muscle Soreness in both thighs, tenderness to the touch, next morning extremely stiff and pa...
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Extreme Muscle Soreness in both thighs, tenderness to the touch, next morning extremely stiff and painful, movement seems to loosen them up a bit, but still painful and sore. Sore all day Sunday so you walk with a limp especially after sitting, up and down stairs hurts the most, still sore on Monday, 3/8/2021
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| 52 | 2021-03-09 | hypersensitivity of all senses, tingling |
paresthesias and hyperesthesia from hips up to scalp. slowly improved over next week, no treatment p...
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paresthesias and hyperesthesia from hips up to scalp. slowly improved over next week, no treatment provided
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| 52 | 2021-03-09 | numbness |
Twelve hours after first vaccine dose, experienced mild facial swelling, numbness. Resolved 6 hours ...
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Twelve hours after first vaccine dose, experienced mild facial swelling, numbness. Resolved 6 hours later without intervention.
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| 52 | 2021-03-10 | tingling, numbness |
Bilateral upper and lower extremity paresthesias, left facial paresthesias and numbness, fasciculati...
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Bilateral upper and lower extremity paresthesias, left facial paresthesias and numbness, fasciculations in abdomen and face
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| 52 | 2021-03-10 | tremor, feeling hot |
Tremor in right am, Injection site swelling and redness, Dizziness and Patient said very hot, Ad...
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Tremor in right am, Injection site swelling and redness, Dizziness and Patient said very hot, Adverse reaction lasted 15 to 20 mins. Treated with Ice packs, gave water and observed for 20 mins.
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| 52 | 2021-03-16 | burning sensation |
Sudden pain and rash appeared, took a single Zyrtec pill and rash and burning sensation went away. N...
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Sudden pain and rash appeared, took a single Zyrtec pill and rash and burning sensation went away. No other medications or change in diet at the time of the reaction were present.
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| 52 | 2021-03-16 | pain in extremity | Sore arm |
| 52 | 2021-03-18 | burning sensation, tingling |
Redness, prickly/itching sensation over face, arms, legs, chest/abdomen, burning sensation on lips a...
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Redness, prickly/itching sensation over face, arms, legs, chest/abdomen, burning sensation on lips and around eyes, pressure/fullness in back of throat, pain in infections site, fatigue, muscle aches.
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| 52 | 2021-03-18 | feeling hot |
3-16-21 2:11PM PT STATES 'CHEST DISCOMFORT AND FELT HOT FOR 1 MIN AFTER GETTING SHOT'. STATES 'NO P...
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3-16-21 2:11PM PT STATES 'CHEST DISCOMFORT AND FELT HOT FOR 1 MIN AFTER GETTING SHOT'. STATES 'NO PAIN OR DISCOMFORT NOW'. A/O, PINK, W/D, RESP REG WITH EASE. AMBULATORY TO EXIT - GAIT BRISK AND STEADY. HOME WITH WIFE. NO ACUTE OR OBVIOUS DISTRESS. 3-17-21 1:28: PT STATES HE 'WENT TO THE ER WITH CHEST TIGHTNESS AND LIGHTHEADED. WAS THERE 5 HR AND WAS CHECKED OUT - EVERYTHING WAS OK'.
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| 52 | 2021-03-19 | weakness |
Delayed reaction with sore throat, nasal congestion, feeling run down, headache. Also the well known...
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Delayed reaction with sore throat, nasal congestion, feeling run down, headache. Also the well known soreness of the injection site in right arm.
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| 52 | 2021-03-19 | pain in extremity |
On 1/27/2021, after having received Dose #2 of Pfizer Covid-19 vaccine on 01/07/21, I experienced se...
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On 1/27/2021, after having received Dose #2 of Pfizer Covid-19 vaccine on 01/07/21, I experienced severe calf pain while playing soccer. Over the next 2 weeks I experienced vascular claudication in that leg and was eventually diagnosed with arterial thrombus in Left tibioperoneal, anterior tibial/dorsalis pedis and posterior tibial arteries. I do not have any known predisposing conditions for arterial thrombus and no history of thromboembolic disease.
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| 52 | 2021-03-20 | weakness |
24-48 he's post vaccine Acute Insomnia with severe anxiety component; 24-48 he's post vaccine Ac...
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24-48 he's post vaccine Acute Insomnia with severe anxiety component; 24-48 he's post vaccine Acute Insomnia with severe anxiety component/Anxiety worsening; Completely out of character with no preceding symptoms; very debilitated; This is a spontaneous report from a contactable physician (patient). A 52-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EH9899), via an unspecified route of administration, administered in left arm on 17Dec2020 8:00 as single dose, second dose via an unspecified route of administration, administered in left arm on 07Jan2021 (Batch/Lot Number: EL3246) as single dose for covid-19 immunisation. Medical history included hypertension and Increased cholesterol. Concomitant medication included atorvastatin (LIPITOR); lisinopril. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. other medications the patient received within 2 weeks of vaccination were Lipitor and Lisinopril. It was reported 24-48 hours post vaccine (18Dec2020 22:00) patient had Acute Insomnia with severe anxiety component. Completely out of character with no preceding symptoms. No prior history of any recent event to explain acute change in personality and character. Insomnia has now persisted for seven weeks. Was better two weeks after 1st dose then worsened again after the 2nd dose was given. Same timeline. Anxiety worsening. Never suffered form any psych issues. Highly functional Interventional Cardiologist now very debilitated. the adverse event result in doctor or other healthcare professional office/clinic visit; The patient received treatment with Psych therapy, Benzos, Ambien, Trazadone, Melatoni. Prior to vaccination, the patient not diagnosed with COVID-19. Since the vaccination, the patient not been tested for COVID-19. The reported seriousness was non serious. The outcome of the events was not recovered.
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| 52 | 2021-03-23 | bell's palsy |
Left sided Bells palsy. Notably pt with remote hx of Bells palsy on the same side. occurred approx 1...
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Left sided Bells palsy. Notably pt with remote hx of Bells palsy on the same side. occurred approx 12 hours after injection.
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| 52 | 2021-03-23 | muscle twitching | My right eye felt like there was something in it and it still seems to be twitching |
| 52 | 2021-03-23 | tingling, numbness |
Pain at injection site expanded to joints and muscles in all parts of the body. Mild sense of swelli...
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Pain at injection site expanded to joints and muscles in all parts of the body. Mild sense of swelling in arms and legs and face, numbness and tingling in extremities. Slight tightness in chest.
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| 52 | 2021-03-24 | facial paralysis, bell's palsy |
On 03/24/2021 @ 0730 am, I experienced drooping and weakness of right side of face and mouth. Diagno...
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On 03/24/2021 @ 0730 am, I experienced drooping and weakness of right side of face and mouth. Diagnosed with Bells Palsy at emergency room. CT was negative for mass. Prescribed Prednisone 20 mg 3 tab daily for 7 days, & Acyclovir 800mg 5 tablets daily for 10 days..
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| 52 | 2021-03-25 | bell's palsy |
New onset bells palsy, 2 days after first vaccine dose, no prior history of bells palsy. treating wi...
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New onset bells palsy, 2 days after first vaccine dose, no prior history of bells palsy. treating with pred/valtrex
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| 52 | 2021-03-25 | facial paralysis, bell's palsy, sensory loss |
Patient was diagnosed with Bells Palsy. On 3/15/21, patient noticed loss of taste and a sensation in...
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Patient was diagnosed with Bells Palsy. On 3/15/21, patient noticed loss of taste and a sensation in his tongue. On 3/16/21, patient had right sided facial paralysis with some right ear discomfort, right eyelid drooping, right upper temple headache, sensitivity to sounds, and right eye only able to be open halfway. Patient also states that his right eye was watery. He denies a mouth droop. Patient went to urgent care on 3/16 and he was prescribed Prednisone. On 3/18, patient went to see his primary care physician and was prescribed an antiviral. He has not had any new or worsening symptoms since 3/18 pm, but he has not seen much improvement in symptoms either. He describes a small improvement in taste.
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| 52 | 2021-03-25 | feeling jittery |
Patient had pallor, reported lightheadedness, felt jittery. Patient reports not having breakfast. Ju...
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Patient had pallor, reported lightheadedness, felt jittery. Patient reports not having breakfast. Juice given and calming techniques provided, did not resolve symptoms. Denies throat swelling or difficulty breathing. Blood pressure elevated, denies history of hypertension. Other vital signs stable.
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| 52 | 2021-03-25 | pain in extremity |
Patient complains of arm soreness, decreased range of motion which started the next day after gettin...
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Patient complains of arm soreness, decreased range of motion which started the next day after getting the shot. Still has the arm soreness, but states that is seems to be a little better than before. Has not tried taking anything for it like ibuprofen or Tylenol. Has not tried a cold pack on it. No swelling, warmth, or redness at site.
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| 52 | 2021-03-25 | unresponsive to stimuli, tremor |
Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive...
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Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: purfuse sweating, lose of sight left eye, dizziness, nausea-Severe, Systemic: Nausea-Mild, Systemic: Shakiness-Medium, Systemic: Visual Changes/Disturbances-Severe, Additional Details: Patient began to fell better about 5 minutes after epinephrine was administered. EMS was called but did not transport.
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| 52 | 2021-03-26 | weakness | Achey, chills, fever, general feeling poorly approx 22 hrs after vaccination |
| 52 | 2021-03-26 | tremor, cold sweat |
1. Headache within 1 hour after shot. Severe after 12 hours. Still light at 48 hours. 2. Muscle ...
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1. Headache within 1 hour after shot. Severe after 12 hours. Still light at 48 hours. 2. Muscle aches within 8 hours. Still light at 48 hours. Peaked at 24 hours after shot. 3. "Glans/local ache' (lower back/kidneys and testicles) within 8 hours. Testicle ache stopped with 36 hours after shot. Kidney/lower back ache still lightly present at 48 hours. 4. Shaking/Chills. Started 12 hours after shot. Went from light to extreme within 30 minutes. Shaking and shivering uncontrollably. To the point I would not have been able to dial 911 for help if I had needed. No matter what I did I could not get warm or stop shaking. Extreme shaking lasting about 2 hours. In about 2 more hours shaking subsided and stopped. So shaking stopped around 16 hours after shot. Chills continued until around 36 hours after shot. 5. Cold sweat/Fever. Sweating starting 11 hours after shot. Lasting until about 36 hours after shot. For fever, Unknown how high it was as I was too busy uncontrollably shaking to take my temperature. Fever remained for about 48 hours in low grade form EXCEPT for hours 11 through 18 after shot - I am sure it was very high due to headache, chills, shaking, etc at that time. Basically, for most of the 2 days, it felt like the flu. But for 6 hours, (hours 11 through 17 after receiving the shot), it was the sickest I can recall beings in decades. Will 'click' I have recovered below in item 20. But not 100% back to normal yet. 90% back to normal would be a good current 'level'. Expect to feel 100% again tomorrow or the next day based on recovery rate.
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| 52 | 2021-03-27 | cold sweat, feeling hot |
About 15-20 minutes after receiving the shot, he reported feeling warm and clammy. He mentioned that...
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About 15-20 minutes after receiving the shot, he reported feeling warm and clammy. He mentioned that was similiar to the beginning of his other reaction. Because he has had a reaction to epinephrine in the past, an ambulance was offered to be called for him, however, he declined. He was offered a 25mg dose of Benadryl with some cold water, and upon afterwards he felt better. It was noted that he had only ate a piece of toast that morning (it was now around 1pm). His wife was called so she would be able to drive him home. Patient stayed for another 30 minutes after before his wife came to pick him up.
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| 52 | 2021-03-27 | numbness, tingling |
High Blood Pressure: 135-91, numbness and tingling in my left hand, and itchiness in my right foot. ...
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High Blood Pressure: 135-91, numbness and tingling in my left hand, and itchiness in my right foot. I also experienced pain and swelling in the injection site.
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| 52 | 2021-03-27 | muscle twitching |
Severe Muscle aches in back and neck lasted for 9 days Muscle twitch in legs came on after 10 days a...
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Severe Muscle aches in back and neck lasted for 9 days Muscle twitch in legs came on after 10 days and ongoing
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| 52 | 2021-03-29 | muscle spasms |
Severe back muscular and intestinal cramping lasting for about 8 hours. Abdomen distention was pron...
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Severe back muscular and intestinal cramping lasting for about 8 hours. Abdomen distention was pronounced. Also very fatigued and lethargic for over 24 hours.
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| 52 | 2021-03-29 | tingling, feeling of insects crawling on skin, muscle spasms |
After 1st dose - stomach began churning constantly within a week, scalp and side of face tingling oc...
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After 1st dose - stomach began churning constantly within a week, scalp and side of face tingling occasionally, After 2nd dose - stomach churning increased, scalp and face tingling more pronounced within 1st week, occasional nausea and tingling in pinky fingers and lack of appetite 2nd week, occasional tingling in pinky toe and sides of ankles as well as more nausea and chest discomfort during 3rd week when resting (1st ER visit), pronounced tingling in fingers and feet as well as farther up legs 4th week when experienced difficulty walking after one night where entire legs had formication and calf cramping (2nd ER visit). Symptoms then dissipated on their own approx 8 weeks after first appearing
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| 52 | 2021-03-30 | weakness |
In the 1-2 weeks after vaccination pt reports generalized weakness, polyuria, polydipsia, weight lo...
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In the 1-2 weeks after vaccination pt reports generalized weakness, polyuria, polydipsia, weight loss, vision changes. Presented to ED on 3/30/2021 and found to have DM2 with A1c of 12.4. Previously had well controlled DM2 on metformin 500mg. Most recent prior A1c was 7.0 on 11/12/2020
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| 52 | 2021-03-30 | face paralysis, numbness, tingling |
Paresthesias in upper and lower extremities; left facial numbness and paresthesias; left facial weak...
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Paresthesias in upper and lower extremities; left facial numbness and paresthesias; left facial weakness; fasciculations in abdomen and face; This is a spontaneous report from a contactable physician. A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 52-year-old intramuscular on 21Jan2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. There were no covid prior vaccination and covid tested post vaccination. The patient experienced Paresthesias in upper and lower extremities, left facial numbness and paresthesias, left facial weakness, fasciculations in abdomen and face on 21Jan2021, resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment was received including Prednisone. The outcome of events was recovering. Information on batch/lot number was requested.
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| 52 | 2021-03-30 | tingling |
After leaving the location I got tingling at the base of my neck, soon after it moved to the left si...
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After leaving the location I got tingling at the base of my neck, soon after it moved to the left side of left side of my the back of my head around my ear, then I started to get ringing in my ear which is progressively getting louder. I am rather concerned.
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| 52 | 2021-03-31 | pain in extremity, tenderness |
arm pain; Also reports joint stiffness around neck and shoulder; Lymphadenopathy-Lymph Node Pain/te...
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arm pain; Also reports joint stiffness around neck and shoulder; Lymphadenopathy-Lymph Node Pain/tenderness on right side- near the axilla, underneath the arm next to the chest; Lymphadenopathy-Lymph node pain around left clavicle; Lymphadenopathy-Lymph node pain around left clavicle; This is a spontaneous report received from a contactable pharmacist (patient himself). A 52-year-old male patient received first dose of BNT162B2 (Solution for injection, Lot Number: EN6205, Expiry date: Jun2021), via intramuscularly to the left arm on 26Feb2021 at single dose for COVID-19 immunization. The patient medical history included Hypertriglyceridaemia ongoing. Concomitant medication included Fenofibrate. The patient previous vaccination included Shingrix used for shingles and experienced with sore arm. The patient lab test included Sar-cov-2 which was negative. Patient reported that he received his first dose of the Pfizer BioNTech covid vaccine on 26Feb2021. He is due for his second dose this Friday 19Mar2021. He is calling because he experienced lymphadenopathy- explains he experienced Lymph node pain/tenderness around his left clavicle. Caller clarified that the injection was on his left side. The pain/tenderness occurred the next day, 27Feb2021 and it was self limiting and it lasted about 5-7 days. He didn't think anything of it, everything else was ok, the arm pain resolved after one day. On 12Mar2021, he developed similar pain on the right side, but it was a more intense pain/tenderness and lasted maybe 4 days. He still experiences it, but less frequently. He is not sure if he is describing it correctly. During the afternoon, it gets a bit more tender. He doesn't feel it in the morning, but by the afternoon he notices the pain/tenderness. He did not know if there were any reports of contralateral lymphadenopathy (lymph node pain). He clarified that there is no redness or lump- he doesn't feel anything, even if he touches it there's no pain, but periodically there will be a shooting tenderness. He feels like it's getting better, but it is still persisting. He clarified that on the right side- he is experiencing pain near the axilla, underneath the arm next to the chest. He is waiting to see if it is improving and doesn't know how long he should wait. He stated that it wasn't that painful on the left side, it was just a little tender; he knew something was different. The pain wasn't always there. Sometimes there's a little pain on the left side still, but not as intense as the right side. The pain is there, it's not worsening but it is not improving. The patient also reports joint stiffness around neck and shoulder and describes discomfort as ongoing intermittent tenderness. The reporter reported events Lymphadenopathy-Lymph node pain around left clavicle, Lymphadenopathy-Lymph Node Pain/tenderness on right side- near the axilla, underneath the arm next to the chest to be serious due to Medically significant. The outcome of events was not recovered. No follow-up attempts needed. No further information expected.; Sender's Comments: Based on the available information, temporal association and known product profile, a possible causal relationship cannot be excluded between the suspect product BNT162B2 and the reported events Lymphadenopathy, Lymph node pain and Tenderness. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 52 | 2021-03-31 | pain in extremity | Swelling, pain in arm, joint pain, chills, slight fever, congestion, headache. |
| 52 | 2021-03-31 | pain in extremity |
Mild symptoms including chills, headache, fatigue, arm soreness more intense than first shot (but no...
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Mild symptoms including chills, headache, fatigue, arm soreness more intense than first shot (but no problems with mobility).
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| 52 | 2021-04-01 | pain in extremity |
heart attacks; bad immune system; lethargic; mild headache; feeling not well; soreness in the arm in...
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heart attacks; bad immune system; lethargic; mild headache; feeling not well; soreness in the arm initially; may be dehydrated; This is a spontaneous report received from contactable consumer (patient) via medical information team. A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration at the age of 52-years, on 20Mar2021 at a single dose for immunisation. The patient's medical history and concomitant medications were not reported. The patient stated that on 20Mar2021, he had the Pfizer covid vaccine and experienced lethargic, mild headache, feeling not well, soreness in the arm initially on an unspecified date. The patient also stated that he had heart attacks, has a bad immune system on an unspecified date and may be dehydrated. The outcome of the events was unknown. Information on the lot/batch number has been requested.
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| 52 | 2021-04-03 | flushing |
Flushing/sweating, dizzy. History of fainting with shots. BPs 154/92, 121/74 (pulse 52). O2 sats 97%...
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Flushing/sweating, dizzy. History of fainting with shots. BPs 154/92, 121/74 (pulse 52). O2 sats 97%, 100%.
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| 52 | 2021-04-04 | burning sensation, numbness and pain in extremities |
I developed cipro toxicity in 2017 due to a dose of cipro combined with steroids. Symptoms include n...
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I developed cipro toxicity in 2017 due to a dose of cipro combined with steroids. Symptoms include neuropathy, tendon damage, vision and hearing issues, muscle aches and burning sensations throughout the body. These symptoms flare. I have been pain free for four months before getting the Pfizer vaccine. All of my symptoms came back 2 hours after the shot.
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| 52 | 2021-04-04 | night sweats | Night sweats starting 5 or 6 nights after vaccine and lasting through at least last night. |
| 52 | 2021-04-06 | weakness, tremor, pain in extremity |
anaphylactic shock Began with neck pain on left side, heavy dry mouth, profuse sweating, saw odd co...
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anaphylactic shock Began with neck pain on left side, heavy dry mouth, profuse sweating, saw odd colors and dashboard of car coming at me in design, very cold and light headed, trouble breathing, throat felt swelled, bowels and bladder felt they were going to let loose. went unconscious, - after recovery I had tremors for a few hours such that I could not hold a glass of water, legs felt hot to the touch and ached for several days. Still feel weak and tired.
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| 52 | 2021-04-06 | weakness | Dizziness, weakness, feeling faint, disoriented, headache, some shortness of breath |
| 52 | 2021-04-07 | numbness, tingling |
Shortly after receiving the first shot, I started getting numbness and tingling in my left hand. I r...
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Shortly after receiving the first shot, I started getting numbness and tingling in my left hand. I received the shot in my left arm. The numbness / tingling still continues today.
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| 52 | 2021-04-08 | weakness |
Severe vertigo with onset approximately 8 hours after injection. Mild fever symptoms but temperature...
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Severe vertigo with onset approximately 8 hours after injection. Mild fever symptoms but temperature wasn't measured. Lethargy and weakness accompanied other symptoms. Symptoms cleared after 48 hours.
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| 52 | 2021-04-08 | flushing | Syncope, Diaphoretic, Flush, arrhythmia |
| 52 | 2021-04-08 | tingling |
Patient reports a sensation of tingling at the site of his vaccine. He reported a sensation of swel...
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Patient reports a sensation of tingling at the site of his vaccine. He reported a sensation of swelling, but no swelling was noted on examination. The symptoms lasted about 15 minutes.
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| 52 | 2021-04-11 | tingling, numbness |
Numbness and tingling from, and including, tips of left thumb, index, and middle finger (ring and li...
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Numbness and tingling from, and including, tips of left thumb, index, and middle finger (ring and little finger unaffected) and extending up top of arm to elbow and tightness in the entire shoulder area. Has been ongoing since onset, and is affected by arm position. Symptoms never fully alleviate, as there is always residual mild numbness in my fingers/hand. Have not sought treatment yet, as I am uninsured and have no idea what my options are. Symptoms are ongoing.
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| 52 | 2021-04-12 | pain in extremity |
Within moments of injection experienced metallic taste in mouth that lasted several days. Day after ...
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Within moments of injection experienced metallic taste in mouth that lasted several days. Day after vaccine experienced fever up to 100.5 (even with 400 mg ibuprofen every 6 hours) that lasted 18 hours. Substantial pain that traveled from shoulder down the left arm. Very large swelling of the lymph node in left arm pit three days after injection. (not recovered from this yet)
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| 52 | 2021-04-12 | sciatica |
Sciatica, muscle pain, back pain. Difficulty walking, sleeping, due to pain. 2 weeks duration (so fa...
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Sciatica, muscle pain, back pain. Difficulty walking, sleeping, due to pain. 2 weeks duration (so far).
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| 52 | 2021-04-12 | tremor, feeling hot, feeling cold, weakness, pain in extremity |
tremors; legs felt hot; legs felt hot to the touch and ached; weak; tired; anaphylactic shock; went ...
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tremors; legs felt hot; legs felt hot to the touch and ached; weak; tired; anaphylactic shock; went unconscious; neck pain; heavy dry mouth; profuse sweating; saw odd colors and dashboard of car coming at me in design; very cold; light headed; trouble breathing; throat felt swelled; bowels and bladder felt they were going to let loose; bowels and bladder felt they were going to let loose; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 02Apr2021 at 14:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies (sometimes seafood and some fresh fruits) from an unknown date and unknown if ongoing. Concomitant medication included lisdexamfetamine mesilate (VYVANSE), lisinopril and lamotrigine (LAMICTAL), all taken for an unspecified indication, start and stop dates were not reported. The patient experienced anaphylactic shock which began with neck pain on left side, heavy dry mouth, profuse sweating, saw odd colors and dashboard of car coming at him in design, very cold and light headed, trouble breathing, throat felt swelled, bowels and bladder felt they were going to let loose. The patient then went unconscious. After recovery, the patient had tremors for a few hours such that he could not hold a glass of water, legs felt hot to the touch and ached for several days. Still feel weak and tired. Reaction began about 18 minutes (also reported as 14:15) after the shot. Therapeutic measures were taken as a result of all events. The outcome of the events was recovering. The events were assessed as serious and life-threatening by the regulatory authority. Information on the lot/batch number has been requested.
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| 52 | 2021-04-13 | difficulty speaking |
Patient received his second vaccination 2 days prior to presentation. States he woke yesterday feel...
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Patient received his second vaccination 2 days prior to presentation. States he woke yesterday feeling tired with associated chills, nausea, decreased appetite and hoarse voice. He was able to go to work as usual. He came home and ate some fish and clam chowder for dinner. Around 7pm that evening, his voice became muffled. Symptoms progressed to difficulty swallowing and sensation of throat swelling so he came to the emergency department for evaluation. On arrival to the ED, he was noted to have water bag edema of the uvula. O2 sats 98% on room air, no respiratory distress. He was treated with diphenhydramine, famotidine, and methylprednisolone and observed. No progression of symptoms noted.
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| 52 | 2021-04-13 | tremor, muscle spasms |
Diarrhea since 04/06/2021 everyday two times per day. On April 8th developed heavy abdominal pains ...
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Diarrhea since 04/06/2021 everyday two times per day. On April 8th developed heavy abdominal pains and fainted became rigid, clenched fists, and shook like a seizure. My wife stood by my side and witness me waking up pale and confused after about 10 seconds of episode. I continue to have diarrhea.
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| 52 | 2021-04-14 | night sweats |
Received a Janssen product 3 weeks earlier. His wife had received the Pfizer and she had a 2nd appt...
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Received a Janssen product 3 weeks earlier. His wife had received the Pfizer and she had a 2nd appt and he thought he needed one as well. Cough, generalized soreness, lethargy, shortness of breath, joint pain, watery diarrhea, night sweats.
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| 52 | 2021-04-14 | tingling | Tingling intermittently throughout body |
| 52 | 2021-04-14 | tingling | Tingling sensation all over my shoulders radiating to both hands. |
| 52 | 2021-04-16 | cold extremities, weakness |
I work 3rd shift Started with chills about 11pm same day as shot, then by 3am my heart rate dropped ...
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I work 3rd shift Started with chills about 11pm same day as shot, then by 3am my heart rate dropped to 48 bpm and extreme shivering. (My normal resting rate is about 80 bpm). Heart rate came back up shortly but still below my normal bpm. When I got home at 7am was very weak and chilled, and on both hands my fingers turned completely white like they wasn?t getting circulation and were very cold.. I went to bed feeling horrible hoping it wasn?t serious and after I slept more than normal, I feel good now. Can?t say my heart rate going that low wasn?t kinda scary.
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| 52 | 2021-04-17 | bell's palsy |
Came down with Bell's palsy symptoms 5 days after injection on the Right side of my face.; This is a...
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Came down with Bell's palsy symptoms 5 days after injection on the Right side of my face.; This is a spontaneous report from a contactable consumer reported for himself. A 52-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 27Mar2021 (Lot Number: ER8732) as single dose for covid-19 immunisation. The patient previously took the first dose bnt162b2 on 06Mar2021 for covid-19 immunization. The patient medical history included allergies to penicillin. The patient's concomitant medications were not reported. The patient came down with bell's palsy symptoms 5 days after injection on the right side of face on 01Apr2021 06:00. Facial paralysis resulted in emergency room visit. Therapeutic measures were taken as a result of facial paralysis included Steroid and Viral scripts. The outcome of event was unknown. No other vaccine in four weeks; No covid prior vaccination; No covid tested post vaccination.
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| 52 | 2021-04-18 | tingling, numbness, pain in extremity |
Numbness, pain and tingling in lower left leg and foot. Started 5-7 days after 1st shot and acceler...
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Numbness, pain and tingling in lower left leg and foot. Started 5-7 days after 1st shot and accelerated after 2nd shot
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| 52 | 2021-04-18 | unresponsive to stimuli |
4 episodes of nausea/vomiting/diarrhea, then found by spouse with altered mental status and nonrespo...
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4 episodes of nausea/vomiting/diarrhea, then found by spouse with altered mental status and nonresponsive/snoring. Taken to Emergency department for stroke evaluation. Ruled out for stroke, intubated for airway protection and cerebral edema with meningeal enhancement observed on CTA. Admitted to ICU.
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| 52 | 2021-04-19 | pain in extremity | Systemic: Big toe swelling/pain day after immunization-Medium |
| 52 | 2021-04-21 | pain in extremity |
Pain and swelling in the elbow of the opposite arm of the shot. Some redness, stiffness and a lot o...
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Pain and swelling in the elbow of the opposite arm of the shot. Some redness, stiffness and a lot of swelling a little over 24 hours after the covid-19 shot.
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| 52 | 2021-04-21 | tremor |
2:30pm - Vaccine administered. Some muscle soreness at the vaccination site, but otherwise no notic...
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2:30pm - Vaccine administered. Some muscle soreness at the vaccination site, but otherwise no noticeable side effects. 1am - 10 hours after vaccine. All over body shaking. Not unlike "chills" but didn't have the cold feeling with it. No accompanying fever at the time. Lasted until 5:30am. 6am - 15 hours after vaccine . Shortly after the shaking stopped, spiked a 101.5 degree fever. That continued until approximately 5am the following day. Took 500mg acetaminophen at 7am, and again at 4pm, and again at 12am. Throughout the following day - 15 hours to 36 hours after vaccine - general body aches (most noticeable in the back), lethargic - but that could have been a result of no sleep the night prior due to shaking. 5pm following day - 27 hours after vaccine - bad headache. That lasted until midnight 5am the next morning - most all side effects gone. Some lethargy but temperature at 98.6 degrees, body aches no longer apparent, headache gone.
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| 52 | 2021-04-22 | muscle spasms | Muscle spasm, twitching of the tongue, soreness in teeth/jaw. |
| 52 | 2021-04-22 | muscle twitching, tremor, grand mal seizure |
52 yo male received first dose of Pfizer vaccine on 3/20 at outside institution. The next morning, p...
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52 yo male received first dose of Pfizer vaccine on 3/20 at outside institution. The next morning, pt experienced uncontrollable tremors and twitching and presented to the ED. In the ED, patient had generalized tonic-clonic seizure that lasted for about 1-3 minutes. CT head scan was unremarkable. Neurology started pt on Keppra 500 mg BID and plan for MRI and routine EEG. The next morning, pt felt back to baseline and was alert and oriented. Patient has a history of HIV and stroke with residual right-sided weakness. He has no history of seizure nor reactions to vaccines. Physician advised patient that he should not receive second dose of vaccine.
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| 52 | 2021-04-22 | pain in extremity, numbness |
4/15 immediate post-injection reaction: "Patient evaluated for chest pain after vaccine. Patient wit...
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4/15 immediate post-injection reaction: "Patient evaluated for chest pain after vaccine. Patient with L sided chest pain and back pain immediately after vaccine. Patient had identical reaction after first dose. When patient was laid in bed and given oral hydration, pain resolved. Patient felt confident that this was anxiety as with his first vaccine. VS and exam WNL. 2 lead EKG showed NSR with no clear ST changes. Patient was returned home with wife as driver. " 4/16 reaction: patient contacted PCP with complaints of "Nausea, stomach ache, headache, injection site discomfort, fatigue, some diarrhea." Patient requested something for nausea. Provider prescribed ondansetron. 4/22: patient contacted PCP with complaints that since 2nd dose, he has felt "Fatigue and feet pain with swelling and intermittent numbness . Also since then has not been able to control CBG, in AMs >200, using medications as prescribed." PCP monitoring; no medication treatments.
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| 52 | 2021-04-22 | pain in extremity |
SIRVA. Patient developed severe left shoulder/arm pain and weakness 48 hours after receiving Pfizer ...
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SIRVA. Patient developed severe left shoulder/arm pain and weakness 48 hours after receiving Pfizer vaccine.
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| 52 | 2021-04-23 | feeling cold |
4/5 - Trip to emergency room, fever 104 to 104.3, headache, backache, neckache (right side), chills,...
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4/5 - Trip to emergency room, fever 104 to 104.3, headache, backache, neckache (right side), chills, muscle aches, diarrhea, lethargic - first 3 days, then next 4 days - intermittent fever - low grade, muscle aches, very lethargic, and diarrhea. (7 or a few more in total) 4/20/21 - 2nd shot - 36 hours of low grade fever, 100 or less, headache, chills, muscle aches and diarrhea.
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| 52 | 2021-04-24 | feeling cold, numbness and pain in extremities |
Significant mental impacts: Depression (to the point of suicidal ideation); Neuropathy in Face, Arms...
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Significant mental impacts: Depression (to the point of suicidal ideation); Neuropathy in Face, Arms, Legs; Sensation of coldness in bones; Extreme sudden fatigue; Significant mental impacts: Depression (to the point of suicidal ideation); Inability to concentrate; Light sensitivity; low grade headache in center of brain; This is a spontaneous report from a non-contactable consumer (patient). A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 03Apr2021 10:30 (Batch/Lot Number: ER8732) as single dose for COVID-19 immunization, in the hospital. Medical history included nonalcoholic fatty liver disease (NAFLD), now almost gone, from an unknown date. The patient has no history of COVID prior vaccination. The patient was not COVID tested post vaccination. There were no concomitant medications. The patient experienced neuropathy in face, arms, legs, sensation of coldness in bones, extreme sudden fatigue, significant mental impacts: depression (to the point of suicidal ideation), inability to concentrate, light sensitivity, and low grade headache in center of brain, all experienced on 04Apr2021 12:00 AM. No treatment was given for the events. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
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| 52 | 2021-04-24 | pain in extremity |
Side effects: light chills, strong headache (3 days, after now 9 days still coming back briefly), fe...
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Side effects: light chills, strong headache (3 days, after now 9 days still coming back briefly), fever (37.8C), muscle pain, body joint pain for 3 days, left arm pain (3 days), sweating (2nd night), fatigue for ~2days, and most importantly: for over 9 days/nights swollen nymph knot under left arm, was as big as a full hand full (like a full bar of soap), has meanwhile improved daily, but I can still sense a small (wallnut size) under the arm now, 9 days after the shot. It's important to inform because the media and the doctors are not reporting how bad and lasting the side effects are and it is important to be transparent to patients what to expect, otherwise trust is eroded and people stop getting vaccinated.
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| 52 | 2021-04-25 | throat numbness |
09:53 tingling / numbness to back of throat no sob or tongue swelling wctm. Recheck 10:10 vs. tingl...
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09:53 tingling / numbness to back of throat no sob or tongue swelling wctm. Recheck 10:10 vs. tingling decrease pt going. instructions for calling EMS should allergy symp. increase. pt stable decreasing symptoms no sign of allergic reactions
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| 52 | 2021-04-26 | tingling, pain in extremity, numbness |
Vaccine April 24th 9:15 am, by afternoon was feeling tingling and numbness in left side of face. Apr...
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Vaccine April 24th 9:15 am, by afternoon was feeling tingling and numbness in left side of face. April 25th, arm hurt, headache (typical), but tingling and numbness was increasing. It felt like I had a novocaine shot. April 25th Doctor said to got to ER. At ER they had me take an EKG, Full Blood Work, CT Scan and CTA Scan. MRI to be determined in a couple days.
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| 52 | 2021-04-27 | pain in extremity |
serious pain on his left leg; This is a spontaneous report received from a contactable consumer, the...
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serious pain on his left leg; This is a spontaneous report received from a contactable consumer, the patient. A 52-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration on 11Mar2021 (Batch/Lot number was not reported) as a single dose (at the age of 52 years-old) for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on an unknown date (Batch/Lot number was not reported) for COVID-19 immunisation. The patient experienced serious pain on his left leg on an unknown date in Mar2021 after the second dose of bnt162b2. The patient underwent lab tests and procedures which included x-ray on an unknown date: which showed x-ray hasn't had any improvement. The clinical outcome of the event serious pain on his left leg was unknown. The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.
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| 52 | 2021-04-28 | weakness |
First vaccine was 3/1/21. 3/2/21 had muscle & joint aches, weakness, low grade temp, swollen lymphoi...
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First vaccine was 3/1/21. 3/2/21 had muscle & joint aches, weakness, low grade temp, swollen lymphoid under arm until 3/3/21. Second vaccine was 3/22/21. Had same symptoms only more severe & higher temp. This time I was sick 4 days & unable to work. I was not better until 3/26/21
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| 52 | 2021-04-28 | slurring, numbness |
Ringing of ears intensified; Face was numb; Slurred speech; Slight swelling of tongue; Slight troubl...
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Ringing of ears intensified; Face was numb; Slurred speech; Slight swelling of tongue; Slight trouble breathing; Wheezing; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: Er8735), via an unspecified route of administration, administered in left arm on 12Apr2021 as single dose for COVID-19 immunisation. Medical history included known allergies on certain beta blockers and macadamia nuts from an unknown date and unknown if ongoing. The patient has no history of COVID prior vaccination and was not COVID tested post vaccination. Concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (lot number= Er6204) on 22Mar2021 11:30 AM, on left arm, for COVID-19 immunisation, and experienced ringing in both ears. Upon receipt of the second shot, ringing of ears intensified and has continued to present. Additionally, approximately 25 minutes after the second shot on 12Apr2021, the patient's face was numb, had slurred speech and slight swelling of tongue, slight trouble breathing with wheezing. Face numbness subsided after 10 hours. The events resulted in disability or permanent damage. No treatment for the events was received. The patient has not recovered from the reported events.
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| 52 | 2021-04-28 | unresponsive to stimuli |
Pt received vaccine, wife was receiving her vaccine and pt became unresponsive, diaphoretic. 1150: C...
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Pt received vaccine, wife was receiving her vaccine and pt became unresponsive, diaphoretic. 1150: Code Medical called immediately. Car seat reclined.. BP 92/50, HR 40, RR18. Pt pale and diaphoretic. 1152: Pt arousing but unable to communicate clearly. BP 98/48, HR 40, RR1. Able to drink OJ, small sips. 911 activated. 1154: Pt removed from car and placed on cot awaiting EMS. 1156: Pt answering questions, remains pale and diaphoretic. BP 102/62, HR 54. Alert & Oriented X3. 1202: EMS arrived and walked pt to ambulance. BS 102, BP 114/68, HR 51. Skin warm and dry. Alert & Oriented. Pt to be transported to ED secondary to decreased Heart Rate.
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| 52 | 2021-04-29 | weakness |
soon after shot, pain in muscle area ...around 11 hrs later,very bad chills, body aches started.. t...
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soon after shot, pain in muscle area ...around 11 hrs later,very bad chills, body aches started.. then as time went on nausea, weakness and running low grade fevers..symptoms getting better and worse over a period of time thru late Sunday morning when started to feel like myself..by the end of the day, felt better..
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| 52 | 2021-04-29 | numbness, tingling |
Tingling and numbness in both arms (below the elbow to hands) & legs (below the knees to the feet). ...
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Tingling and numbness in both arms (below the elbow to hands) & legs (below the knees to the feet). Started in right arm and progress to the other extremities within a few hours. Neurologist has seem me and is conduction further tests including an EMG. Test is being taken 4/30/21. At this time the tingling and numbness has climbed above the knee and has stayed the same in the arms.
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| 52 | 2021-05-10 | pain in extremity |
pt woke up Friday morning (after having had vaccine on Wednesday evening) with R calf pain and swell...
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pt woke up Friday morning (after having had vaccine on Wednesday evening) with R calf pain and swelling. He was sent to ER, where he was diagnosed with DVT
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| 52 | 2021-05-14 | pain in extremity |
Blood Clot in right leg; Severe pain in leg; cry; This is a spontaneous legal report (Marketing Prog...
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Blood Clot in right leg; Severe pain in leg; cry; This is a spontaneous legal report (Marketing Program) from a contactable consumer (patient himself). A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection) dose 2 (Batch/Lot Number: EW0770) via an unspecified route of administration, on 21Apr2021 11:30, as single dose for covid-19 immunization. Medical history included Asthma ongoing, Diabetes had been on and off since 2018, Covid-19 in an unspecified date in Jan2021. The patient received dose 1 (Batch no/Lot Number: ER8732) via an unspecified route of administration, on 29 Mar 2021, as single dose for covid-19 immunization. The patient's concomitant medications were not reported. On 21Apr2021 around 11:30-12:00 in the night the patient experienced Blood clot in his right leg, had a severe pain and cannot walk, feels like he's being stabbed in the leg every time he gets up. He had to keep his legs up all the time and not put them down. He stated that his life was going to be upside down for 6 months because of the Covid vaccination. Stated that was unacceptable. Reporter also said that if the blood clot breaks off it could be dangerous. Said it was substantial; it was all the way up to his groin, not its down almost to his knee and goes all the way down to his ankle. Patient went to the hospital last Saturday due to pain in the back of his leg. The pain started 12 hours after the second Covid vaccine. He wanted to cry he was in so much pain. He could not take anything for it. Patient stated that if the clot breaks off, he was dead. So, he had to put everything on hold because he did the right thing which ended up being the wrong thing. Patient stated that the pain in his leg was a 13 or 14 on a scale of 1-10. Patient took Tylenol and Pain patches did not work on a blood clot. Patient stated that when he was in the hospital, 4 different doctors, told him the event was at least 50 if not 100 percent caused by the Covid dose of vaccine. Patient stated that after the first dose of vaccine he was sick as a dog and he said that the clot may have started with the first dose of vaccine, stated that he had a 102 degree fever a few minutes after the vaccination, felt dizzy and thought he was going to fall over. Patient stated that he got the vaccination dose to get his life back and now he could not, that what about in 6 months if he had to get a booster vaccine and probably go through it all over again; or to be on quarantine. Patient stated that he went with his 84-year-old mother to get the vaccine. Patient said that the only reason she didn't get a blood clot was because she was already on blood thinners and said that he is the one who takes care of his mom and now he cannot walk barely, he had Covid in January and that people who had Covid shouldn't be taking these vaccinations because they have immunity, he talked to a doctor and a woman yesterday who still have their antibodies a year after having Covid. He said that the vaccine was injuring people. He was hospitalized related to his leg pain and diagnosed with the blood clot from 24 Apr 2021 to 27 Apr 2021. In the hospital he was told to him take Oxycontin or Morphine. He said that he did not want to take those and end up addicted. He said after a motor vehicle accident he had in 2002 he took Naprosyn and it helped, he said could not take that now because he was on a blood thinner. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had tested COVID-19 positive prior to vaccination. This is to notify that potential legal action from a reporter in the attached source document booked into AER 2021506757 and 2021506972. The outcome of the event Blood Clot in right leg and Severe pain in leg was not recovered, feels like he's being stabbed in the leg was recovered and cry was not recovered. Information on Lot/Batch number was available. Additional information has been requested.
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| 52 | 2021-05-16 | pain in extremity | Loss of use of right arm from shoulder to wrist |
| 52 | 2021-05-17 | flushing, weakness |
On 11/08/20 the client had symptoms of fever up to 103.5 F, chills tachycardia 117 bpm, O2Sat nadir ...
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On 11/08/20 the client had symptoms of fever up to 103.5 F, chills tachycardia 117 bpm, O2Sat nadir of 85%, respiratory rate 22, development of hypotension with BP 85/55 bpm with weakness, drowsiness, chills, flushed skin, bilateral edema both lower extremities with wheezing and rhonchi throughout both lungs and was sent to a local medical hospital for treatment where he tested positive for COVID and was returned to the psychiatric hospital after a 3 day stay and 2 administrations of remdesivir on 11/09/20 and 11/10/20 improved. The client subsequently received the Pfizer COVID19 vaccinations on 12/29/20 and 01/19/21 from different lot numbers noted above. On 5/16/21 the client began to have respiratory symptoms including temp of 99.5, pulse 103 O2 Sat of 85% with rhonchi responsive to albuterol inhalation and subsequently albuterol nebulizer treatment; however the following day symptoms progressed with weakness, wheezing, cough, shortness of breath, pallor and O2 saturation 77% unresponsive to albuterol nebulizer treatment. He was was transferred to a local medical hospital for treatment of severe respiratory symptoms and tested positive for COVID a second time and after the complete Pfizer COVID19 vaccination series approximately 4 months prior. He is still hospitalized at the medical hospital at the time of this report (2 days).
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| 52 | 2021-05-19 | weakness |
Clinical Support 3/31/2021. Exposure to SARS-associated coronavirus +1 more. Dx Labs Only. Reason fo...
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Clinical Support 3/31/2021. Exposure to SARS-associated coronavirus +1 more. Dx Labs Only. Reason for Visit ED Discharged 4/30/2021 (2 hours) Treatment team. Providers COVID-19 Clinical impression, Fever, Generalized Body, Aches, Chills. Chief Complaint Patient presents with Fever, Generalized Body Aches, Chills. HPI: 52-year-old male with history of diabetes, hypertension, obesity presents the emergency department with gradual onset of moderately severe generalized nasal congestion with associated cough unproductive of sputum and fever, T-max 103.8 at home the patient states began approximately 1 week prior to arrival. The fever worsened today and he decided to be seen at that time. He states he had his first dose of Pfizer COVID-19 vaccine 3 weeks ago. Denies sick contacts, chest pain, shortness of breath, syncope, dizziness, lightheadedness, numbness, focal weakness, abdominal pain, nausea, vomiting or diarrhea, changes in bowel or bladder habits or other complaint. No other signs or symptoms and no treatment prior to arrival. ED Discharged 5/1/2021 - 5/2/2021 (5 hours). Last attending Treatment team COVID-19 +1 more. Clinical impression, Chest Discomfort, Chief complaint. ED Provider Notes. Expand AllCollapse All. HPI. Chief Complaint Patient presents with. Chest Discomfort. Patient History. 52-year-old male with history of asthma, diabetes, heart murmur, hypertension, obesity, sleep apnea and was seen in the emergency department yesterday complaining of generalized nasal congestion, fever and cough and was discharge with a diagnoses of COVID-19 4/30/2021 presents to the emergency department with complaint of chest tightness. The patient states that tonight he developed chest pain which woke him from sleep. He describes the pain as burning. He states the pain is similar to the pain he had when he had a gallbladder attack. He also states the pain is well localized and does not radiate. Initially the pain was 10/10 initially and is currently a 4/10. He took his temperature and states he had a fever of 101.6 and took 1,000 mg of tylenol just prior to arrival. His O2 saturation today has not gone under 90%. Medical History. Past Medical History: Diagnosis Date Asthma 5/29/2017, Diabetes mellitus, Heart murmur, Hypertension, Obesity, Sleep apnea, obstructive. APAP 8-20CM WME AIRVIEW. Surgical History. Past Surgical History: Procedure Laterality Date CARDIAC CATHETERIZATION 03/2004. OTHER SURGICAL HISTORY ear surgery as a baby. STRABISMUS SURGERY repair of congenital strabismus-childhood. Family History. Problem Relation Age of Onset. Hypertension Mother. Diabetes Father. Hypertension Father. Hearing loss Other. Kidney disease Other. Social History. Tobacco Use. Smoking status: Never Smoker. Smokeless tobacco: Never Used Vaping Use. Vaping Use: Never used. Substance Use Topics. Alcohol use: No. Drug use: No. Review of Systems. Constitutional: Positive for fever. Respiratory: Positive for chest tightness. Cardiovascular: Positive for chest pain. All other systems reviewed and are negative. ED to Hosp-Admission. Discharged 5/4/2021 - 5/6/2021 (2 days) Hospital. Last attending Treatment team Acute hypoxemic respiratory failure due to COVID-19. Principal problem. Presenting Problem/History of Present Illness/Reason for Admission. Acute hypoxemic respiratory failure due to COVID-19. Hospital Course. Patient is 52 yo BMI around 40, presents to the hospital with severe sepsis secondary to COVID-19 pneumonia. He was first positive on 04/30, had progressive shortness of breath with weakness and worsening cough. He presented to the hospital originally on 05/04, and desaturated to 85% on room air. He admitted to the medicine service, pulmonology was consulted. Severe sepsis (tachycardia, tachypnea, and fevers with acute hypoxemic respiratory failure) secondary to COVID-19 pneumonia. He was started on dexamethasone IV, and transition to oral dexamethasone. He will continue 7 more days at home to complete 10-day therapy. He was started on remdesivir therapy and received 3-day treatment. Pulmonary consulted, as he was a possible candidate for Actemra, however his inflammatory markers including D-dimer, ferritin, CRP improved, and his oxygen requirements also improved. On discharge, he will continue with oxygen supplementation 2 L with rest, 4 L with activity, 2 L with sleep to be infused into his CPAP therapy. Hyperlipidemia. Continue rosuvastatin 10 mg Monday, Wednesday Friday. Benign essential hypertension. Holding hydrochlorothiazide Continue lisinopril and metoprolol.
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| 52 | 2021-05-19 | cold extremities |
I passed out or fainted; I passed out or fainted; Hand and feet were extremely cold; This is a spont...
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I passed out or fainted; I passed out or fainted; Hand and feet were extremely cold; This is a spontaneous report from a contactable consumer. A 52-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Right arm on 04May2021 (Batch/Lot Number: EW0164; Expiration Date: Aug2021) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 05May2021, 1 day after the administration of vaccine the patient experienced I passed out or fainted and Hand and feet were extremely cold. Clinical course reported as I passed out or fainted and my hand and feet were extremely cold before fainting. Patient stated, that he had been trying to report an adverse reaction to the Pfizer COVID 19 Vaccine, the second shot through the 'portfolio' on the website and he tried 3 times and for whatever reasons it just won't transmit the information. So he was wondering, it is possible to report that with a live agent today. The outcome was not recovered for Hand and feet were extremely cold and unknown for rest of the events.
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| 52 | 2021-05-20 | inability to speak |
The patient had Covid 19 from approximately January 28, 2021 through early February 2021. He receive...
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The patient had Covid 19 from approximately January 28, 2021 through early February 2021. He received the first dose of the Pfizer Vaccine on March 26, 2021. On March 27, 2021 at approximately 7:30 PM, the patient suddenly became unable to speak clearly and walk normally. The ambulance was called at approximately 7:45 PM. The patient was evaluated and placed in the ambulance by approximately 8:15 PM. He stopped breathing in the ambulance. He was resuscitated and placed on a ventilator at some point. After evaluation at the hospital, it was found that he had suffered a pontine hemorrhage. He was kept alive until his heart stopped on March 29, 2021.
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| 52 | 2021-05-23 | muscle spasms | Severe Cramping in Legs and Left Side of Stomach |
| 52 | 2021-05-24 | breast pain |
Left of my breast, almost in the armpit region, it is swelled up, and a bit tender and sore; Left of...
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Left of my breast, almost in the armpit region, it is swelled up, and a bit tender and sore; Left of my breast, almost in the armpit region, it is swelled up, and a bit tender and sore; Left of my breast, almost in the armpit region, it is swelled up, and a bit tender and sore; This is a spontaneous report from a contactable other HCP reported for himself. A 52-years-old male patient received second dose of BNT162B2 (BNT162B2, Formulation: solution for injection, Batch/Lot Number: EL9261; Expiration date: Unknown) via intramuscular route of administration, in left arm on 25Jan2021 at 06:45am as single dose for COVID-19 immunization. No Medical history was reported. There were no known allergies to medications, food, or other products. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and other medications within 2 weeks of vaccination. Prior to vaccination, the patient did not diagnose with COVID-19. No other medications the patient received within 2 weeks of vaccination. The patient previously received the first dose of BNT162B2 (solution for injection, Batch/Lot number: unknown) on an unknown date for COVID-19 immunization and experienced no adverse event. On 27Jan2021, the patient experienced left of my breast, almost in the armpit region, it is swelled up, and a bit tender and sore. It was reported that the events were four days after patient 2nd dose. No treatment was received for the adverse event. The most recent COVID-19 vaccine was administered in hospital. Since the vaccination, the patient has not tested for COVID-19. Events were reported as non-serious. The outcome of the events was not recovered. Follow-up attempts were completed. No further information was expected.
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| 52 | 2021-05-24 | hot flush |
Received fax on Thursday. Had ?normal? fatigue next day. On Saturday woke up feeling better. Saturda...
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Received fax on Thursday. Had ?normal? fatigue next day. On Saturday woke up feeling better. Saturday evening aroun 7:30pm felt hot flash and had sweats and my back started to ache. Pain continued and also radiated from center abdomin and left side and intensified. No sleep as I has fairly severe pain all night. Sunday consulted with nurse and was advised Togo to the ER. Went to ER at Hospital around 5:07pm. Had several tests conducted including CT SCAN which revealed bloackage in the splenic vein. Admitted and started me on morphine and also started Heparin blood thinner. Many many blood tests and additional CT scan conducted. Released on Tuesday around 12:30pm. Still have painful spasms as a result of the damage done to spleen. According to Dr, it may take 2-3 weeks before spleen is healed and spasms are gone. Follow up visit TBD in 2 weeks.
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| 52 | 2021-05-25 | pain in extremity |
Patient had his 2nd dose of the pfizer vaccine 05/25/2021. Patient is c/o left arm pain and chest pa...
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Patient had his 2nd dose of the pfizer vaccine 05/25/2021. Patient is c/o left arm pain and chest pain with pressure that started since last night, 05/24/2021. He denies any SOB, fevers, abdominal pain, or swelling, redness, or tenderness at injection site on the left upper arm. Told the patient to please go to the nearest ER for evaluation of the chest pain; patient verbalized understanding and states that someone will take him to the ER
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| 52 | 2021-05-27 | bell's palsy, weakness |
signs of a transient ischemic attack; lost control of the left side of the face and possibly of the ...
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signs of a transient ischemic attack; lost control of the left side of the face and possibly of the left side of his body; lost control of the left side of the face and possibly of the left side of his body; elevated blood pressure 180/100 and came down to 140/100 after the one-hour long episode; weakness; This is a spontaneous report from a contactable consumer (patient's son) via Medical Information team. A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 08May2021 at 15:30 (at the age of 52 years old) (Batch/Lot number: EW0176, Expiration date was unknown) as the 2nd dose, single for COVID-19 immunization. The patient previously received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number: ER8730, Expiration date was unknown) on 17Apr2021 at 2:30 PM (at the age of 52 years old) for COVID-19 immunization. The vaccine was not administered at the military facility. Relevant medical history included ongoing high cholesterol, ongoing high low density lipoproteins (LDLs), ongoing high triglycerides, and patient might have borderline diabetes, possibly prediabetic, but the reporter was not quite sure. The patient had family history of heart problems. The patient was taking unspecified concomitant medications, but the reporter did not know the medications that the patient was taking. It was also reported that the patient was not completely compliant with his medications. The patient had no additional vaccines administered on the same date of the Pfizer suspect. Prior to vaccinations (within 4 weeks), the patient had no other vaccinations and there were no adverse events (AEs) following prior vaccinations. The reporter stated that in the morning at the time of the report on 13May2021, about 5 days after the second COVID-19 vaccine, the patient had signs of a transient ischemic attack; he lost control of the left side of the face and possibly of the left side of his body; he had elevated blood pressure 180/100 and came down to 140/100 after the one-hour long episode; and he experienced weakness, but was able to move around. At the time of the report, the patient was on his way to the emergency room (ER). The event "loss of control of left side of face" did require a visit to the emergency room. It was further reported that the patient had signs of a transient ischemic attack and loss of control of the left side of his face and maybe the left side of his body, but the reporter was not sure; he also had some weakness and this episode lasted about an hour during which time the patient's blood pressure was 180/100. After the hour, his blood pressure came down to about 140/100. The patient was able to move around and on the way to the emergency department. No further information was available regarding the patient's visit to the emergency room at the time of the report. The reporter was asking for information on transient ischemic attacks and the Covid 19 vaccine and if there were reports of strokes as well. The reporter stated his family called several doctor friends and doctor relatives and based on the patient's symptoms, it seemed likely that he had a transient ischemic attack. The outcome of the events was unknown.
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| 52 | 2021-05-27 | bell's palsy | right sided Bell's Palsy that started 5 days after second vaccine |
| 52 | 2021-05-28 | pain in extremity |
Full blown flu symptoms; Severe headache; Random sharp muscle pain; Fatigue; Joint pain; Chills; Fev...
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Full blown flu symptoms; Severe headache; Random sharp muscle pain; Fatigue; Joint pain; Chills; Feverish; Sore arm; This is a spontaneous report received from a contactable consumer. A 52-years-old male patient received first dose of bnt162b2 (BNT162B2,Formulation: Solution for injection, Lot Number: Unknown), via an unspecified route of administration (at the age of 52-year-old), administered in right arm on 02Mar2021 10:15 at a single dose (1ST DOSE, SINGLE) for covid-19 immunisation. Medical history included hypertension and gerd. Concomitant medications included daily multivitamin, atenolol, chlortalidone and lansoprazole (PREVACID). The patient had known allergies chantix and prozac. Patient not diagnosed with COVID-19, prior to vaccination. Patient not tested for COVID-19, since the vaccination. The patient experienced severe headache, random sharp muscle pain, fatigue, joint pain, chills and feverish on 03Mar2021 10:30. On 02Mar2021, the patient had sore arm. On 04Mar2021, patient had full blown flu symptoms. No other vaccines within 4 weeks prior to the COVID vaccine. He returned to work on 05Mar2021 with just minor fatigue. The outcome of the events was recovered with sequelae while sore arm and full blown flu symptoms were unknown. No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
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| 52 | 2021-05-28 | tingling, numbness |
Numbness/tingling right arm since vaccine. Sweaty palms since vaccine. Chest pain starting 18MAY, sh...
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Numbness/tingling right arm since vaccine. Sweaty palms since vaccine. Chest pain starting 18MAY, shortness of breath associated with it 20MAY, continued chest pain with relief when leaning forward- concern for pericarditis
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| 52 | 2021-05-30 | muscle spasms, seizure, unresponsive to stimuli, flushing |
Received the vaccine and then sat in waiting area with no immediate issues. After about 10 minutes ...
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Received the vaccine and then sat in waiting area with no immediate issues. After about 10 minutes started to feel flushed and a couple seconds later blacked out. When coming around, felt disoriented and nurse was asking me questions as I was still sitting in chair. My wife reported that I was having a seizure and stiff against the wall with eyes rolled back and unresponsive for about a minute. My right arm was cramping, BP 220/180 and pulse 44. The clinic staff laid me on the floor and call an ambulance that took me to the ER for observation and testing.
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| 52 | 2021-06-01 | tingling, feeling cold, numbness, muscle spasms, pain in extremity |
feels like there are little tiny baby hands pinching his internal organs throughout his abdomen; Eye...
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feels like there are little tiny baby hands pinching his internal organs throughout his abdomen; Eyes swollen and his vision was diminished; Eyes swollen and his vision was diminished; On his injection arm- 2 inches away from the injection site appeared a size of a gigantic golf ball/A huge lump appeared a few inches from injection site; Numbness from his ankle to his feet and from his knees to his feet/numbness in legs and feet; feels like it's cold and tingly; feels like it's cold and tingly; ringing ears; pressure in his neck to his injection site; back pain/pain in back; vision is blurry; throat was swollen.; Toes locking up; Really dizzy and really lightheaded; Mind has been foggy; Glands were swollen; Arm soreness; Nose is bone dry; tiredness/tired; injection site pain/injection site soreness; This is a spontaneous report from a contactable consumer (patient, self-reported). A 52-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0173 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 08May2021 at 02:38 PM, as a single dose for COVID-19 immunization. The patient did not receive any other vaccine in four weeks. The patient's medical history included Bug bite (happened 5 days prior to 30Apr2021 and regimen of an antibiotic). He was completely done with the rotation for a least 8 days before he got the vaccine. It might have something to do with this. concomitant medication included dicloxacillin (started it on 30Apr2021 and it was for 5 days. He did not know what it did was). The patient reported that on 08May2021, day one, he experienced, tiredness and injection site pain. On day 2, until now side effects which had not gone away. It hadn't gotten worse, but it was not any better. The patient felt like congestion, but his nose was bone dry, like crusty dry. It hurts a little bit because it was so dry and he had arm soreness, nothing out of the ordinary. The arm soreness was just normal injection stuff. At first it was a little tender on the injection spot. It went away after about a day. On 10May2021, the patient felt like there were little, tiny baby hands pinching his internal organs randomly throughout his abdomen. It was not a sharp pain, more like a little squeeze all through his abdomen. It felt like his whole throat was swollen. It was not visually swollen, it more felt like a football in his neck. Stretching it was helping. His toes have been locking up like a pre-clamping. He had numbness from his ankles to his feet for 8 days, and now he has numbness from his knees to his feet. It was not completely numb, but it was not normal. The feeling of baby hands pinching his internal organs started the second day after the vaccine and has stayed consistent. The patient's eyes swollen, and his vision was diminished. Day 2 through today, it felt like his eyes were swollen, his vision was seriously diminished, he had a golf ball sized welt on his arm not at the injection site but 2 inches from it, and he was really dizzy and really lightheaded and almost fainted at the corner store. The feeling like his eyes were swollen started on day 3 after the vaccine. The crease of his eye be-low the eyebrow and on top of the socket got red and puffy and looked like sunburnt skin does. It was at the point that now it feels swollen all the time almost like he had pink eye and his vision has been diminished about 30%. He had a test done yesterday and his vision was 20/25. Some-times he could not even read a text and had to stare at his phone for 10 minutes to make out words. He did not have these issues before. The feeling of his eyes being swollen was a little better in the mornings and about 1300 it gets worse when he gets lightheaded to where was when it started. His vision became diminished about day 3 after the vaccine. It was a little better in the morning, but in the afternoon, it goes to exactly the same as when it started. He noticed the golf ball sized welt on his arm about 3 days ago. The doctor seemed to think a drop of the injection might had travelled from the injection site and his body was creating a defense to it. It was scary to take a shower and then see that. It didn't hurt. It was not painful, but it was a weird foreign entity. The cramping in his toes started probably day 3 and was consistent. The numbness started on day 2 after the vaccine, and up until 3 days ago it was just his ankles and feet. 3 days ago, it got to the point where it was from his knees to his feet. It has gotten worse since it was now travelling up his legs. On his injection arm- 2 inches away from the injection site appeared a size of a gigantic golf ball - when asked with his doctor he said that he thinks that a drop of the vaccine travelled and his body building a reaction to it and it was very abnormal. The patient also had numbness from his ankle to his feet worsened and from his knees to his feet- almost feels like it was cold and tingly. The patient also had dizziness and lightheaded about day 2 after the vaccine and it was the same. It came in waves but was consistent throughout the day. He would be fine then had a wave of dizziness. He has been laying down so much because he was so tired, ringing ears, felt like his glands were swollen, pressure in his neck to his injection site, and back pains. The patient stated that his doctor was only form urgent care. The patient Felt like whole throat was swollen, toes locking up, really lightheaded, mind has been foggy, and arm soreness. The patient had bizarre side effects from the Covid Vaccine for 11 days now. He thought it was the smart thing to report them to Pfizer. He didn't like to give personal information. He declined to give his mailing address or his email address. He hated when asked for race, but he guessed it might be important. He did not have a mailing address, phone number, or email address handy for his physician. He went to Urgent Care yesterday to have it checked and they did an EKG and said he had to be sent by ambulance to the ER. The doctor did bloodwork, and she said everything looked alright and to rest a few more days and keep hydrated. The patient underwent the lab work and procedures which included chest X-ray with unspecified result. He thinks it was on 18May2021. His mind has been foggy with all of that. It was yesterday or the day before. He could not be sure. He has been sleeping so much and was in a complete daze. The fogginess he had the whole time as his other symptoms, and it was the same. He has been eating well and hydrating and taking a multivitamin and Gatorade, all the things' people say to do. He asked if Pfizer has heard of this before. He was panicked it might be chronic, and he worries about the safety of the second shot for him. He was sure many people haven't reacted, but these are freaky side effects. He asked for advice and if Pfizer had heard of this before or if he was some weird anomaly. On his way to get the vaccine he asked 2 people at the city health line if they had taken it and they both said no. He asked 3 other patients and they said they took the Pfizer. One woman said she will take it when they make her. The guy who gave him the shot lied and said he wasn't eligible. It might have been his way of not having to discuss it. The events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient was not diagnosed with Covid prior vaccination. The patient was tested for Covid post vaccination with Nasal Swab on 18May2021. The outcome of the events was not recovered. Device Date: 23May2021,Additional information has been requested.
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| 52 | 2021-06-02 | coordination abnormal, weakness |
dizziness; nausea; He did not feel well at all and was not able to feel well enough to stand up.; de...
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dizziness; nausea; He did not feel well at all and was not able to feel well enough to stand up.; definite lack of coordination; he vomited on himself; his cholesterol was high at 208.; had very little strength; started feeling like something was wrong; just had sort of a feeling like being really drunk; passed out (fainted) in his car 3 times; He was told he had a vasovagal reaction; This is a spontaneous report from a contactable consumer (patient). A 52-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 15May2021 10:50 (Lot Number: EW0173; Expiration Date: 31Aug2021) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included vasovagal reactions in high school. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient's concomitant medications were not reported. Within 2 minutes of receiving the Covid 19 vaccine he started feeling like something was wrong. He pulled to the side in the parking garage and as soon as he stopped the car he passed out. He woke back up and was able to put the car in park and he passed out a second time. He woke up again and his foot was on the gas pedal and he tried to roll down the window. He was able to roll down the window but he wasn't able to get anyone's attention. He passed out a third time. When he woke up again he wasn't able to get the door open and he was nauseated. He basically had nausea, dizziness, and a definite lack of coordination. He just had sort of a feeling like being really drunk. He doesn't drink. He had very little strength but he was able to push his car horn. He was out of it. He could see someone in his car mirror a little ways behind his car and the horn didn't get the person's attention so he honked a second time and someone came to help him, maybe from the fire department and maybe some emergency medical technicians. He was placed on a golf cart or ATV to be transported downstairs to a waiting ambulance and while on the ride he vomited himself. He mentioned that the EMTs called it a vasovagal reaction. He was brought to the hospital in which he had a lot of tests done. He did not feel well at all and was not able to feel well enough to stand up. He had tests done at the hospital, a chest x-ray and his blood was drawn. He had a cardiac ultrasound later in the afternoon the next day on 16May2021. The doctor's didn't find anything wrong other than his cholesterol was high at 208. He was admitted to the hospital on 15May2021. He continued to have his blood drawn through the night and the next morning, on 16May2021, he had a CAT scan. For his cholesterol he was told to eat better and maybe follow up with a doctor in a couple months to check his cholesterol again. No one had any answers to the effect of what happened to him. Everything was fine, his tests were normal. He was told he had a vasovagal reaction. He's had vasovagal reactions before and he can tell this was much different than the vasovagal reactions he's had before. In the past when he's had vasovagal reactions the world went black like looking through a small circle, his vision got blacker and blacker and then he'd pass out. He did not have this feeling with the Covid 19 vaccine. He can only describe this feeling that he had like an occasion in his past when he's drank to much and he's stumbling around. He may have passed out briefly to someone helping him move to a bed and his arms are weighted and he can't lift them and he's disoriented but still has a sense of what's going on but he feels like he could vomit at any second. He's comparing his experience to the Covid 19 vaccine to drinking to much alcohol and then falling asleep or passing out. He was pretty much out of it for 5 hours. Between the fourth and fifth hours after receiving the Covid 19 vaccine he was comfortable enough to stand on his own for brief moments. He was feeling better and was able to use the restroom. By the next day, around the 24 hour period after the vaccine he was feeling almost normal. He was released from the hospital the next day, 16May2021 at around 4:00PM. He was maybe in the hospital for about 27 to 28 hours. At the hospital he had all these tests and he was found to be healthy with no problems. He also had a Covid 19 virus test, he never asked what the results were but he's going under the assumption that if he was Covid 19 virus positive the hospital staff would have told him. Passing out, nausea, dizziness required a visit to Emergency Room. The outcome was unknown.
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| 52 | 2021-06-06 | tremor | -Dizziness -Mental fogginess -Tremors |
| 52 | 2021-06-08 | muscle spasms |
Severe headache; Whole body pain; All day Vomiting; Nausea; Muscle Spasms; Intense Chills; fever cyc...
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Severe headache; Whole body pain; All day Vomiting; Nausea; Muscle Spasms; Intense Chills; fever cycle; Very High blood pressure; This is a spontaneous report from a contactable patient. A 52- year-old male patient received first dose of BNT162B2 (Pfizer BioNTech covid 19 vaccine) (Lot no.: EN6207) via an unspecified route of administration in right arm on 12Mar2021 at 12:00 PM (at the age of 52-years-old) as a single dose for COVID-19 vaccination. Medical history included high blood pressure and thyroid disorder. He also thought he had a false negative covid test in Jul2020, and actually did have covid in Jul2020. The patient did not have any allergies to medications, food and other products. Concomitant medication lexapro, losartan, DIM (as reported, unspecified), retinol (vitamin A), vitamin d and phytomenadione (VITAMIN K), trazadone within 2 weeks of vaccination for an unknown indication. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient had not diagnosed with COVID-19 prior to the vaccination. Since the vaccination, patient was not tested positive for COVID-19. On 13Mar2021, patient trip to the emergency room (ER) for severe headache, whole body pain, muscle spasms, intense chills and fever cycle, very high blood pressure, all-day vomiting and nausea. Nothing they tried eased any of the symptoms. There is no amount of ibuprofen or acetaminophen. He threw up nausea medicine. Two doses of morphine at the ER took the pain from a 10 to a 7. He had never, ever felt this badly. The clinical outcome of the events severe headache, body pain, muscle spasms, intense chills, fever, very high blood pressure, vomiting and nausea was not resolved. No follow-up attempts are possible. No further information is expected
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| 52 | 2021-06-09 | weakness, pain in extremity |
weakness; fatigue; body aches; headache; sore throat; chills; fever; slight arm pain; chest cold; co...
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weakness; fatigue; body aches; headache; sore throat; chills; fever; slight arm pain; chest cold; cough; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0183), via an unspecified route of administration in left arm on 20May2021 at 00:45 (at the age of 52-years-old) at 1st dose, single dose for COVID-19 immunization. The patient's medical history was not reported. He has no known allergies and was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included sertraline hydrochloride (SERTRALINE). He did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered was at an urgent care center. On 21May2021, the patient experienced slight arm pain for the first 2 days after the shot. On 23May2021, 3 days after the shot, he experienced weakness, fatigue, body aches, headache, sore throat, chills, and slight fever. On May2021, 4 to 5 days after the shot, cough and sore throat became more severe. He still had some fever, but it was reduced by ibuprofen. On 25May2021, 5 days after the shot, he still has cough like he has a chest cold. He also reported that all symptoms started to decrease. Since the vaccination, the patient has not been tested for COVID-19. Therapeutic measure was taken as a result of fever and included treatment with ibuprofen. He did not receive any treatment for all other events. The outcome of the event "slight arm pain" was recovered on 23May2021 and recovering for all other events.
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| 52 | 2021-06-10 | hot flush |
Caller stated he got the second shot two days ago and that next day he had a rash.; when he is in a ...
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Caller stated he got the second shot two days ago and that next day he had a rash.; when he is in a hot room like 78 degrees with the window open he can not take the heat like he used to; Hot flashes; rash got bright pink, patient stated within that second day of getting the first dose it was pink, then it came back again after the second dose and now the rash was healing; Scrapes in hands little dots now and skin peeled away got worse. Still a little pink on pinky but have little scabs. Last time felt tight but not it is stinging; felt like he was drugged; pulse rate has been a little elevated; Palpitations: Caller stated this started the same day 10 to 12 hours after getting the first shot. Caller stated it was getting somewhat better but after the second shot it got worse.; getting out of breath was reported as worsened; felt like there was pressure in his skull; he felt like he was going sideways and had to grab onto rail for 30 seconds to a minute so would not fall ove; Blood pressure went down to 124/78 and so his blood pressure has been better since the vaccine; This is a spontaneous report from a contactable consumer (patient, self-reported). A 52-year-old patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: EW0183; expiry date: 31Aug2021) via unspecified route of administration in left arm on 01Jun2021 as single dose of COVID-19 immunization. The patient's medical history and concomitant medications was not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: EW0173; expiry date: 31Aug2021) via unspecified route of administration in left arm on 11May2021 as single dose of COVID-19 immunization and experienced palpitations, felt like he was drugged, felt like there was pressure in his skull, getting out of breath, rash got bright pink, respiratory rate was somewhere around 16, blood pressure went down to 124/78 and so his blood pressure has been better since the vaccine, pulse rate has been a little elevated, on his first finger, the thumb, there was a rash that started bubbling up below the middle knuckle. On an unspecified date in Jun2021, after second dose of vaccination, the patient experienced palpitations, getting out of breath like when he was walking up and down the stairs especially when carrying laundry or a garbage can and he never had this problem doing that unless he had an upper respiratory infection and prior to the vaccine he was perfectly fine, palpitations was reported as worsened, getting out of breath was reported as worsened, rash on his left side where he got the shot on his hand, specifically the top of hand and on his first, second, third, fourth, and fifth finger was reported as worsened, on his first finger, the thumb, there was a rash that started bubbling up below the middle knuckle was reported as worsened, crack in the knuckle area on the second finger was reported as worsened, rash got bright pink was reported as worsened, felt like he was drugged, Blood pressure went down to 124/78 and so his blood pressure has been better since the vaccine, pulse rate has been a little elevated, felt like there was pressure in his skull, felt like he was going sideways, and on 01Jun2021 experienced hot flashes. On 02Jun2021, he was in a hot room like 78 degrees with the window open he cannot take the heat like he used to. On an unspecified date in Jun2021, patient stated that palpitations got worse after the second shot it was started on the same day of first shot of vaccination, 10 to 12 hours after getting the first shot. The patient stated it was getting somewhat better but after the second shot it got worse. On 03Jun2021, that next day of vaccination, patient had a rash and explained that on his first finger, the thumb, there was a rash that started bubbling up below the middle knuckle, this stopped a week to ten days after the first dose and then it came back after the second. Patient had a crack in the knuckle area on the second finger: patient stated he was scheduled for the dose around 12:20 and they had to get more vaccines and so he had to get it around 3:00pm. The patient stated this started to feel bad in the first two hours. For the event of rash got bright pink, patient stated within that second day of getting the first dose it was pink, then it came back again after the second dose and now the rash was healing. Scrapes in hands little dots now and skin peeled away got worse. Still a little pink on pinky but have little scabs. Last time felt tight but not it is stinging. For the event "felt like he was drugged" patient stated this started within 4 hours of first dose, he started to feel better in 5 days and then 10 days after he was completely better and stated he got this again from the second shot and it was getting better but the more he exerts himself the slower he feels but he does not feel like he is on anesthesia. The patient stated that his pulse rate has been a little elevated, stated on the following day after first dose his pulse rate was 114 and 120 was the highest. He stated after the first dose it was between 116 to 120 and after the second dose it was slightly elevated like 90 or something. The patient stated but his pulse rate has been 86, 87, 90 so the pulse rate has been a little elevated. The patient reported he also had hot flashes. He felt like there was pressure in his skull, 10 to 12 day after the first vaccine and this got better, then within 7 to 10 days after the second shot he got it again and he anticipates that for 7 to 10 days he will have to deal with the same crap. The patient felt like he was going sideways, this stopped within two days after the first dose and then it happened within one day or a day in half after the second shot. The patient stated that hot flashes lasted a day or day in a half. The other problem he had noticed is when he is in a hot room like 78 degrees with the window open, he cannot take the heat like he used to. Reportedly, after the second shot they had the patient sit for 15 minutes and so he went to the hospital main area after to get a pass to eat and he felt like he was going sideways and had to grab onto rail for 30 seconds to a minute so would not fall over. He stated the first hour or so after the vaccine he felt like he was drug and he even had caffeine and got his car cleaned, but he felt like his body was behind him like woozy to stomach like in slow motion with exertion and it felt like he was drugged. The patient stated he just wished the vaccine dosage had a high of like if it was 0.3 maybe should be 0.2. The patient stated there should be a different regimen based on height and weight. The outcome of the event "hot flush" was resolved on 01Jun2021, for the event "Palpitations: The patient stated this started the same day 10 to 12 hours after getting the first shot. The patient stated it was getting somewhat better but after the second shot it got worse", "getting out of breath was reported as worsened", "The patient stated he got the second shot two days ago and that next day he had a rash", "he felt like he was going sideways and had to grab onto rail for 30 seconds to a minute so would not fall over", "felt like there was pressure in his skull", "Blood pressure went down to 124/78 and so his blood pressure has been better since the vaccine", "felt like he was drugged", "pulse rate has been a little elevated", "when he is in a hot room like 78 degrees with the window open he cannot take the heat like he used to" was not resolved and for the event "Scrapes in hands little dots now and skin peeled away got worse. Still a little pink on pinky but have little scabs. Last time felt tight but not it is stinging" was unknown, for the event "rash got bright pink, the patient stated within that second day of getting the first dose it was pink, then it came back again after the second dose and now the rash was healing" was recovering.
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| 53 | 2021-01-05 | feeling hot |
Fairly rapid onset of excess fatigue, difficulty keeping eyes open associated with oscillating visio...
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Fairly rapid onset of excess fatigue, difficulty keeping eyes open associated with oscillating vision, near simultaneous distortion of sound (at the time was watching a show using my phone, and the actors no longer sounded like themselves), sense of subtle disequilibrium, and a sense of intense heat involving my upper abdomen and lower chest, centered around my xiphoid process as if being pressed up against a space heater, the latter symptom was non-painful, perhaps the best example is the feeling one has after receiving intravenous contrast dye for CT imaging although more the "warmth" was more intense. Lasted 90-120 minutes before going to sleep, then gone by morning.
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| 53 | 2021-01-05 | pain in extremity |
Extreme Arm Soreness Painful axillary lymphadenopathy on side of injection Flu like symptoms (Fever...
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Extreme Arm Soreness Painful axillary lymphadenopathy on side of injection Flu like symptoms (Fever, HA, Muscle aches, malaise, chills) Abdominal cramping
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| 53 | 2021-01-07 | feeling hot |
within 10 minutes of receiving vaccine, patient reported having neck tightness and chest tightness; ...
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within 10 minutes of receiving vaccine, patient reported having neck tightness and chest tightness; patient was feeling warm and blood pressure was elevated; diphenhydramine 25mg was given and patient was taken to ER. ER reported it was a mix of a slight reaction and anxiety from receiving the vaccine. Patient was sent home from ER and is doing fine.
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| 53 | 2021-01-07 | migraine |
Server pain at the injection site to the point it is hard to move the arm, and it woke me up when I ...
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Server pain at the injection site to the point it is hard to move the arm, and it woke me up when I rolled onto it. Migraine headache with visual pain and nausea. I have taken Tylenol and ibuprofen for the pain and discomfort and I have also been icing the injection site. I missed work today because of the migraine
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| 53 | 2021-01-10 | pain in extremity | Sore Arm, Body Aches- resolved 24 hr |
| 53 | 2021-01-12 | cold sweat |
Received 2nd vaccination in series on 11 JAN 21. By next morning started to experience some muscle a...
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Received 2nd vaccination in series on 11 JAN 21. By next morning started to experience some muscle and joint symptoms. By afternoon of 12 JAN 21 experienced sudden onset loss of bladder control for first time in his life, followed a few hours later by blurry vision, vertigo, motion sickness, emesis and cold sweats that drenched his clothes. Taken to ER by paramedics, and admitted for further observation and evaluation for underlying neurologic vs. cardiogenic problems. Given positional treatments by PT for possible otoliths. Feels much improved on afternoon of 13 JAN 21, but symptoms not fully resolved. Will likely be discharged from hospital on 14 JAN 21 if problems continue to resolve.
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| 53 | 2021-01-13 | pain in extremity, feeling of body temperature change, migraine, tremor |
Headache; migraine; tenderness at injection site; Ten hours after injection he had shaking, sweats, ...
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Headache; migraine; tenderness at injection site; Ten hours after injection he had shaking, sweats, hot and cold flashes, and augmentation of myalgias; Ten hours after injection he had shaking, sweats, hot and cold flashes, and augmentation of myalgias; Ten hours after injection he had shaking, sweats, hot and cold flashes, and augmentation of myalgias; Ten hours after injection he had shaking, sweats, hot and cold flashes, and augmentation of myalgias; Ten hours after injection he had shaking, sweats, hot and cold flashes, and augmentation of myalgias; Fatigue; This is a spontaneous report from a contactable physician (patient). A 53-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on right deltoid on 05Jan2021 07:45 at single dose for covid-19 immunization. Family history included migraine (other family members). Medical history included mild blood pressure and kidney stones, reactive airway disease. Concomitant medication included colecalciferol (VITAMIN D), potassium, allopurinol and hydrochlorothiazide/valsartan for mild blood pressure and kidney stones, fluticasone propionate, salmeterol xinafoate (ADVAIR) for reactive airway disease, atorvastatin, and multivitamins. The patient previously took fluticasone propionate, salmeterol xinafoate (ADVAIR) and experienced dry mouth and lost sense of taste. The patient also previously took Tdap booster on Aug2020, Shingrix on 10Aug2020, and influenza on 12Oct2020; all for immunization; and tetanus injections for immunization and experienced localized tenderness. The patient had the first dose of BNT162B2 (lot number: EH9899) for COVID-19 immunization on 15Dec2020 and experienced localized tenderness at injection point. The received his second dose of COVID vaccine on 05Jan2021. With the first dose he had increased localized tenderness at injection site on 15Dec2020, and he rated it mild to moderate. He would say it was 80% resolved in 24 hours. It had completely resolved in 36 hours. He would say that he has recovered completely form the localized tenderness with the first dose. Then he noted his second dose was yesterday, in the context of not having much sleep the night before. The actual injection was uncommonly eerily painless. The other folks in his department had similar experience. Maybe it was the nurse who gave the injection. Maybe it was because it was the same area and sensitivity was decreased. They had to check the Band-Aid to make sure blood was there. The administration was painless. He was relieved when the arm started getting sore to know he actually received it. He had increased arm tenderness at injection site which he rated as moderate which has now resolved. It got to moderate where lifting the arm up was sore. He definitely knew that he had been vaccinated. He got the vaccine at 7:45AM and now it is 16 to 17 hours later and he would say the pain is mild now. It did persist. The first vaccine hurt a little more. He expects this to go away. Ten hours after injection he had shaking, sweats, hot and cold flashes, and augmentation of myalgias. He had unrelenting headache over night that was moderate to severe. He said it kept him awake. It was exacerbated by lying down. Sitting up helped him. It became a migraine which is something he doesn't often experience. Migraines are pretty rare for him. He took 800mg of Advil at 6AM that helped for headache and migraine. The weight of the patient was 250 to 255 pounds. Shaking, sweats, hot and cold flashes, and augmentation of myalgias have resolved. Everything has resolved except for a little headache. In the background he literally had one or two hours of sleep. He thinks that likely precipitated a migraine was increased. Last night he slept literally an hour. He took 800mg of Advil and fell asleep. He is operating on 2 hours of sleep in 48 hours. Most of the stuff is gone except a little headache and expected fatigue. Headache Seriousness Criteria: he would say that it was relatively disabling. He would not have been able to carry on. He wouldn't have been able to operate last night. It would have interfered. It was dissimilar to others. He gets rare migraines. Everything was amplified with a migraine. He certainly felt that. It was fair to say the vaccine precipitated the migraine that was mild or severe. He doesn't want to falsely attribute these things to the vaccine. Causality Headache: precipitated by the vaccine. In the context that he had not slept the night before. He had a nasopharyngeal COVID test and it was negative. He has been in a COVID study where they are looking at combination. They developed a saliva test at (Name). There is a combination of saliva oropharyngeal and immunoglobins. He has been negative multiple times. The outcome of the events headache and fatigue was not recovered and recovered for the rest of the events.; Sender's Comments: A causal association between BNT162B2 and the reported event headache cannot be excluded based on a compatible temporal relation between vaccination and onset of events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 53 | 2021-01-14 | weakness |
30 hours post injection mild weakness and fatigue; Onset began 18 hours after injection. 100.2 fever...
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30 hours post injection mild weakness and fatigue; Onset began 18 hours after injection. 100.2 fever; chills; body aches; extreme fatigue; Bedridden 8 hours; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable nurse, the patient. A 53-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EJ1685, via an unspecified route of administration on 07Jan2021 at 15:00 (at the age of 53 years old) as a single dose in the left arm for COVID-19 vaccination. Medical history included high blood pressure from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination, but did receive the first dose of BNT162B2, lot number: EJ1685 on 19Dec2020 at 16:15 in the left arm. On 08Jan2021 at 09:00 (reported as onset began 18 hours after injection), the patient experienced 100.2 fever, chills, body aches, extreme fatigue, bedridden 8 hours. It was reported that 30 hours post injection (08Jan2021 at 21:00) he experienced mild weakness and fatigue. The patient did not receive treatment for the events. The clinical outcome of 100.2 fever, chills, body aches, extreme fatigue, bedridden 8 hours, mild weakness and fatigue was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 53 | 2021-01-15 | pain in extremity, numbness | Headache, Fever, Chills, L arm soreness and numbness Narrative: |
| 53 | 2021-01-20 | weakness | I was sick all day fevers chills dry heaves no energy |
| 53 | 2021-01-20 | numbness, tingling |
mild SOB, facial tingling/numbness, flush, light headed all while eating lunch. Pt sats 100%. No res...
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mild SOB, facial tingling/numbness, flush, light headed all while eating lunch. Pt sats 100%. No resp distress noted. LS CTA. VSS. Denies chest pain or other symptoms
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| 53 | 2021-01-23 | flushing |
The injection site seemed inappropriately high in the shoulder/deltoid. No aspiration attempted. I ...
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The injection site seemed inappropriately high in the shoulder/deltoid. No aspiration attempted. I had a dripping sweat occur at the five to fifteen minute range. There was a flushing sensation during this. After a few minutes, it all abaited. The bandaid was saturated with blood. My arm was never sore and I had zero symptoms after the initial reaction. I believe this injection was given intravascularly. I have not been able to find ANY information to address the effectiveness of this route if administration and I seriously fear that I am not covered.
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| 53 | 2021-01-25 | numbness |
Numbness in the right thigh anterior and lateral aspects; This is a spontaneous report from a contac...
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Numbness in the right thigh anterior and lateral aspects; This is a spontaneous report from a contactable physician (patient). This 53-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) 2nd dose (lot number:EJ1686) 06Jan2021 01:00 PM at left arm at single dose intramuscular for Covid-19 immunization. Facility type vaccine was hospital. Medical history was reported as "none". Patient had no known allergies. Concomitant drug in two weeks included finasteride (PROPECIA), acetylsalicylic acid (ASPRIN), atorvastatin, and multivitamin. Patient received 1st dose of BNT162B2 (lot number: EK5730) on 17Dec2020 01:30 PM at right arm for Covid-19 immunization. No other vaccine received in four weeks. It was unknown if covid prior vaccination. No covid tested post vaccination. Patient experienced numbness in the right thigh anterior and lateral aspects on 13Jan2021 starting on 09:00 PM. No treatment received. Outcome of the events was not resolved.
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| 53 | 2021-01-27 | weakness, tremor |
Extreme chills, shaking, shivering x 1 day, loss of appetite, diarrhea x 2 days, weakness, lighthead...
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Extreme chills, shaking, shivering x 1 day, loss of appetite, diarrhea x 2 days, weakness, lightheaded x 3 days, shortness of breath x 4 days
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| 53 | 2021-01-28 | pain in extremity |
After my second dose, I felt fin at around 10pm like the first dose my arm started to become achy. ...
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After my second dose, I felt fin at around 10pm like the first dose my arm started to become achy. I go to work around 230AM and when I was putting my contacts in my right eye had a huge busted vessel to the right side of my pupil.
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| 53 | 2021-01-30 | bell's palsy | Bilateral facial nerve palsy started on 1/24/2021, left side worse than right. |
| 53 | 2021-02-12 | facial paralysis, bell's palsy |
Development of left sided facial Bells Palsy, initially started on Thursday 2/11/2021, symptoms wors...
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Development of left sided facial Bells Palsy, initially started on Thursday 2/11/2021, symptoms worsened until left mouth and eye droop on Saturday 2/13/21. Went to Urgent Care on 2/13/21 and received diagnosis of Bells Palsy. Prescribed Prednisone 60mg daily x 7 days. Will start today - 2/13/21
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| 53 | 2021-02-13 | weakness |
12 hours after shot started chills, body aches, severe headache. 24 hours after shot, same condition...
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12 hours after shot started chills, body aches, severe headache. 24 hours after shot, same conditions, with nausea. 48 hours after shot same conditions, with vomitting. Unable to eat or drink and would just throw it up. 72 hours, severe headache, extreme light and sound sensitivity, nausea. 96 hours finally starting to feel better. Mild symptoms, such as slight headache, weakness.
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| 53 | 2021-02-17 | pain in extremity |
Pain in arm; This is a spontaneous report from a contactable consumer (patient). A 53-year-old male ...
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Pain in arm; This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received the first dose of bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration, on 26Jan2021 08:00 AM at a single dose on the left arm for COVID-19 immunization. The most recent COVID-19 vaccine was administered at a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Medical history was none. The patient had no known allergies to medications, food, or other products. The patient had no concomitant medications. On 26Jan2021 02:00 PM, the patient experienced pain in arm. No treatment was received for the event. Outcome of the event was recovering. Since the vaccination, the patient has not been tested for COVID-19. The reporter assessed the event as non-serious. Information on the lot/batch number has been requested.
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| 53 | 2021-02-18 | feeling hot | hives (left arm, neck, upper legs, chest), itchiness, "feeling hot all over" |
| 53 | 2021-02-22 | tingling, numbness |
as I mentioned, he had a fever and aches one day prior to the first vaccine. following the vaccine ...
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as I mentioned, he had a fever and aches one day prior to the first vaccine. following the vaccine the fever spiked as high as 103 and fatigue continued. four days later a rash developed on his back, and a dry cough developed. He also is experiencing and continues to experience some numbness/tingling in his legs and arms. Two Saturdays following the vaccine he went to the ER and was diagnosed with pneumonia in both lungs. However, a fourth covid test was given and it was negative like the previous three tests.
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| 53 | 2021-02-24 | weakness | Fatigue, body pain, weakness , headache. |
| 53 | 2021-02-28 | numbness, tingling |
After waiting 15 minutes in the observation room, I left as I was feeling fine. About 10 minutes la...
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After waiting 15 minutes in the observation room, I left as I was feeling fine. About 10 minutes later, as I was driving home, I had an odd taste in my mouth and my right cheek started to go numb. I arrived home and started looking for answers (Pfizer information page that lists side effects). The sensation lasted about an hour or so, then started to subside. By the time I went to bed, there was just a little tingle at the edge of my cheek bone. Other than being tired and a bit woozy, I feel better today.
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| 53 | 2021-03-01 | flushing |
Patient felt flushing across chest, sat down and symptoms resolved, patient then reported feeling sw...
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Patient felt flushing across chest, sat down and symptoms resolved, patient then reported feeling sweaty and wanting to lie down. Patient was assisted onto the floor by staff. No Loss of consciousness. Patient transferred to ED for evaluation. Patient received IV fluids and 0.25 mg alprazolam. Patient was discharged home from ED.
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| 53 | 2021-03-04 | numbness |
Progress Notes Expand AllCollapse All COVID VACCINE CLINIC 2/24/2021 Subjective Pt. is a 53 y....
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Progress Notes Expand AllCollapse All COVID VACCINE CLINIC 2/24/2021 Subjective Pt. is a 53 y.o. male who was seen at COVID Vaccine Clinic today for his first dose of the COVID 19 vaccination. He was given the Pfizer vaccination in the right deltoid muscle. During his 15 minute waiting period after the injection, the patient began to experience numbness in right forearm and headache. He denied difficulty breathing, difficulty swallowing, itching and lightheadedness. This provider was notified of patient reaction and he was then assessed in the emergency area. Monitored patient for severe reaction symptoms, including but not limited to rapid progression of symptoms and skin changes. ALLERGY REVIEW OF SYSTEMS: Patient denies chills, fever, facial swelling, cough, chest tightness, shortness of breath, wheezing, dizziness and headaches Numbness right forearm.: Previous Reactions: None Objective Vitals Vitals: 02/24/21 1208 BP: 124/77 Pulse: 83 SpO2: 95% Physical Exam Constitutional: Appearance: Normal appearance. HENT: Head: Normocephalic and atraumatic. Mouth/Throat: Comments: No swelling or lips or tongue. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing or rales. Musculoskeletal: General: No swelling or deformity. Comments: No rashes noted on right arm where injection was given. Equal strength in bilateral upper extremities. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: He is alert and oriented to person, place, and time. Assessment/Plan Treatment included: Tylenol 1000mg and water. Follow up response to treatment: good. Sx completely resolved. Discussed that he may take Ibuprofen this evening if he experiences some numbness in the right forearm or fingers. He denied symptoms of headache and numbness resolved prior to discharge. I walked with patient to exit the facility. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Local reaction (arm pain, bleeding/bruising, mechanical irritation, localized rash) Electronically Signed 2/24/2021 12:09 PM
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| 53 | 2021-03-08 | pain in extremity, muscle twitching |
following injection i had increased pain in back and into legs. it increased to point of week of Feb...
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following injection i had increased pain in back and into legs. it increased to point of week of February 1 I was having difficulty at work. on 2/5/2021 i started having fesiculations in both lower extremities at rate of 300-400 per minute. pain increased in lower back and thighs. These increased to point of inability to work related to inability to sit more than 15 seconds and need of walker to mobilize. I scheduled with back specialist and neurologist, ended up hospitalized on 2/18/2021 released on 2/21/21 with diagnosis of benign fesiculations meaning no testing identified cause. currently still unable to work.
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| 53 | 2021-03-08 | pain in extremity |
1st symptom: Within 30 seconds, ache in arm from elbow to wrist. Got worse over next few minutes, f...
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1st symptom: Within 30 seconds, ache in arm from elbow to wrist. Got worse over next few minutes, fairly uncomfortable for about 45 minutes before subsiding slightly (tried to keep moving arm as recommended). Pain returned when I drove to work and while at my desk. Lasted for approx 4 more hours. Injection at 11:15am, pain mostly ended around 9:30pm (except when reaching or extending arm, pain in shoulder now mostly). 2nd symptom: Mild nausea starting about 5 min after injection, while in waiting room. Passed when laying down at home before work, approx 45 min later.. Started again while driving to work and lasted from about 4pm to 8pm. Subsided about 10pm. 3rd symptom - feel very fatigued.at typing of this report at 10pm - started about 5pm. So far nothing else - no headache or chills for example. No pain at all at the actual injection site - now the pain is mostly above it - from the shoulder joint to near the injection site (maybe a couple inches above.) as well as the forearm, all around. To make coping easier in case the symptoms (arm ache, fatigue, etc) are worse as commonly described from the 2nd dose I put in and was approved for PTO from work for scheduled 2nd date on March 30th. Will allow me to rest (avoid being effected at work with the fatigue and an even more achy arm as expected side effects of 2nd dose)
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| 53 | 2021-03-09 | bell's palsy, facial paralysis |
About 7pm the same day I got my vaccine. My right eye started watering profusely. I didn't think muc...
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About 7pm the same day I got my vaccine. My right eye started watering profusely. I didn't think much of it. at 10:30 I went outside to whistle for a dog and I could not whistle. The next morning I found that the right side of my face was completely drooped and I have no expression control.
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| 53 | 2021-03-10 | cold extremities | visual disturbance/blurry, cold feet, dizzy, sob, dry throat. Evaluated by EMS-Cleared |
| 53 | 2021-03-11 | feeling hot |
Warm - No fever, just very warm with a red face Muscle fatigue and soreness General fatigue from usi...
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Warm - No fever, just very warm with a red face Muscle fatigue and soreness General fatigue from using any muscle... standing... walking...etc. I have no issues at all with performing any of these activities All symptoms were gone after approximately 36 - 48 hours
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| 53 | 2021-03-12 | numbness, numbness and pain in extremities, flushing |
Started with itching burning rashes neuropathy headaches fatigue and dizziness. Now have mouth sores...
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Started with itching burning rashes neuropathy headaches fatigue and dizziness. Now have mouth sores that won?t heal and debilitating malaise fatigue A few days later: Joint pain and air hunger A few days later: Numb extremities Two weeks to date: Body temp regulation issues , heart pounding, face flush. Sleep disturbance entire time. Extreme fatigue.
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| 53 | 2021-03-16 | pain in extremity |
Arm pain began evening of vaccine. About 48 hours after vaccine patient felt light headed and dizzy...
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Arm pain began evening of vaccine. About 48 hours after vaccine patient felt light headed and dizzy. He drank water and sat down. Then felt like he needed to lay down. About 1/2 hour later his heart rate was up and oxygen levels low. His blood pressure was also high. He was pale and pasty looking. No fever. This lasted about 1/2 hour but he still didn?t feel right. He felt fine about 2 hrs after the incident. Then he experienced chest pain In the middle of the night .
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| 53 | 2021-03-16 | speech disorder, flushing |
flushing and difficulty talking Narrative: Patient had similar reaction previously to tetanus immu...
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flushing and difficulty talking Narrative: Patient had similar reaction previously to tetanus immunization with flushing and difficulty talking/thick mouth
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| 53 | 2021-03-18 | tingling |
tingling in lips and sinuses 10 min. after vaccine -dizziness /lower lip slightly swollen /bp 124/84...
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tingling in lips and sinuses 10 min. after vaccine -dizziness /lower lip slightly swollen /bp 124/84 pulse 82 -c/o tightness in throat -swallowing -no respiratory issues
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| 53 | 2021-03-20 | pain in extremity, burning sensation, feeling cold, tremor |
Vaccine given at 10am. He worked all day, home at 11pm. He said the pain from the shot in his arm ha...
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Vaccine given at 10am. He worked all day, home at 11pm. He said the pain from the shot in his arm had traveled to his neck.At around 11:45 pm he got out of bed and became FREEZING, started shaking, teeth chattering, fever of 101. I gave him Tylenol pm to halt the fever. He was up all night shaking, teeth chattering, burning with fever. This morning the fever is 100. He had Covid over Thanksgiving which started the same way. He went to the ER with Covid and could not get out of bed for ten days. No additional medical treatment at this time
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| 53 | 2021-03-21 | feeling hot | Patient feels hot, dizzy, lethargic |
| 53 | 2021-03-23 | pain in extremity, tingling |
Began approximately 17 days after injection Dull ache at the injection site with sharp pain radiatin...
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Began approximately 17 days after injection Dull ache at the injection site with sharp pain radiating down my left arm and up into my left trapezius muscle; tingling sensation in fingers of my left hand
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| 53 | 2021-03-24 | weakness |
No adverse effects initially. On second day after the vaccine, I woke up feeling like I had sustain...
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No adverse effects initially. On second day after the vaccine, I woke up feeling like I had sustained some kind of shoulder injury: significant reduction in motion, weakness, pain. So far it has lasted two days.
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| 53 | 2021-03-24 | tremor | Rocking tremors back and forth in pelvis |
| 53 | 2021-03-25 | bell's palsy, facial paralysis, numbness |
About 30-45 minutes I began to feel tingling in my tongue and throat. A few hours later my face beca...
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About 30-45 minutes I began to feel tingling in my tongue and throat. A few hours later my face became numb - it was a circle around my face. The next day (3/7) the right side of my face was numb and showing symptoms of what doctors later decided was Bells Palsy. on 3/7 I had fatigue and general feeling bad like I had the flu. On Monday 3/8, I was feeling worse and I called the advice nurse who advised I go to the Emergency room due to right face partial paralysis, numbness, and face drooping. They diagnosed Bells Palsy and prescribed Valtrex and prednosone. From 3/9-12 the right side of my face was numb, droopy and I had ear pain and a lot of fatigue. By Saturday 3/13 I was feeling better and have gradually gotten better through today 3/26. I still have numbness in my right cheek. and occasional tingling in my lips. My doctor has advised me to go ahead and get the second dose of vaccine tomorrow 3/27. Also, during the week of 3/7 - 3/12 I had some dizziness and a general foggy feeling in my head.
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| 53 | 2021-03-28 | weakness, pain in extremity |
for one day only felt like had the Flu: body aches, low-energy, head ache and left arm sore. By morn...
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for one day only felt like had the Flu: body aches, low-energy, head ache and left arm sore. By morning of 29th felt better
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| 53 | 2021-03-30 | muscle spasms |
I received the first dose of the Pfizer vaccine on 3/16 and did not feel any adverse effects until o...
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I received the first dose of the Pfizer vaccine on 3/16 and did not feel any adverse effects until one week later. On 3/23 I started feeling a few twinges on my left side where my bra strap is normally, and then on 3/25 I noticed a rash in that same area. I thought it might be a reaction from the vaccine since it was on the same side as the injection site. But within a few days it was noticeably worse and painful. I went to urgent care on 3/27 and was diagnosed with shingles. I am now on antiviral medication and prednisone.
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| 53 | 2021-03-30 | seizure | dizziness, sweat passed out, seizures |
| 53 | 2021-03-31 | flushing |
15 minutes after receiving vaccine, client began c/o headache, flushing, diaphoresis, and dizziness....
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15 minutes after receiving vaccine, client began c/o headache, flushing, diaphoresis, and dizziness. Vital signs were obtained. BP was elevated. Client given oral Benadryl after c/o itching. No rash noted. Obtained VS every 15 minutes while monitoring for 45 minutes post Benadryl administration. VS stabilized. Client stated he was feeling better and was released home with spouse driving.
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| 53 | 2021-03-31 | pain in extremity, tremor, feeling of body temperature change |
Very sore arm within 12 hours of 2nd shot on Wednesday March 24th. Woke up the next day feeling "off...
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Very sore arm within 12 hours of 2nd shot on Wednesday March 24th. Woke up the next day feeling "off" and irritated. By 9pm Thursday my entire body ached severely as if I had a very bad flu. By 11pm I had very severe cold & hot shakes and felt extremely nauseous until the next morning. I checked my temp every couple hours and never was I above 98.5 but, I felt extremely sick until about 48 hours after the 2nd shot. On Friday, and for the next 2-3 days, I felt fatigued as if I was recovering from the flu. Only a flu that was without fever or any respiratory issues. By Monday I felt normal again.
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| 53 | 2021-03-31 | pain in extremity |
Shortly after shot began to experience shoulder and elbow pain in left arm. Shoulder pain went away...
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Shortly after shot began to experience shoulder and elbow pain in left arm. Shoulder pain went away after 48 hours but the elbow pain has persisted for almost a week. The pain in on the back side of my elbow at the crux.
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| 53 | 2021-04-01 | tingling |
Last night, I was doing dishes and felt a brief, sharp pain at the injection site. Immediately afte...
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Last night, I was doing dishes and felt a brief, sharp pain at the injection site. Immediately afterwards, I got a tingling sensation that went from my left cheek to elbow. It lasted a bit but wasn't very bad , considering some of the side effects I had heard of. Then, on April 2nd, I found that touching the injection site caused the same reaction, albeit not as bad. This occurred twice today. When I looked the symptoms up on the web, I didn't find any mention of this. However, Google seems to have seen something because before I could get the entire search term in, it completed for arm tingling. At this point, I decided to report it. Again, the reaction is very mild, but very odd.
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| 53 | 2021-04-04 | flushing |
a few minutes after receiving the vaccine, the patient became flush and lightheaded. He was lowered...
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a few minutes after receiving the vaccine, the patient became flush and lightheaded. He was lowered to the floor where he never went unconscience, but did get very pale and sweaty. His blood pressure was low at 99/60. He reported he had not eaten. He was given glucose tabs and after 15 minutes began to feel better. he drank water and was observed for 30 minutes. He did not report this had happened previously, but did say he did not like needles or blood.
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| 53 | 2021-04-05 | numbness |
numbness to the left side of the face / tonque. pt denies any difficulty swallowing / breathing &/o...
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numbness to the left side of the face / tonque. pt denies any difficulty swallowing / breathing &/or other s/s. No visual swelling to the tongue. Medics present. pt. waiting another 30 mins to be monitored.
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| 53 | 2021-04-05 | tremor | Extreme body tremors that wax and wane. |
| 53 | 2021-04-06 | weakness |
Whole body hurts and standing up is difficult for more than 10 minutes. Right side of body is in a l...
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Whole body hurts and standing up is difficult for more than 10 minutes. Right side of body is in a lot of pain and I can?t hold anything up
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| 53 | 2021-04-06 | pain in extremity, nerve pain, feeling hot |
Immediately after the shot , I felt arm get strangely itchy , then my left arm was very warm for a c...
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Immediately after the shot , I felt arm get strangely itchy , then my left arm was very warm for a couple hours. I told the Dr there , they released me after 20 min , as there was no serious pain . After couple of days with Sore Arm pain , my left ribs area became a little sore and starting to have what felt like nerve jolts from left side of my Neck down my left arm. The Neck pain and nerve feeling got steadily worse over the next 3-4 days , on the 5th or 6th day the pain was so bad I could not move out of bed in the morning for over 2.5 hours. With a sudden move there was lightening bolt type pain shooting down left arm and right leg. Pain subsided over the next 3-4 days. I would say now it's 90% .
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| 53 | 2021-04-07 | feeling hot |
Placed follow up called on 4/5/2021 at 1:25pm: Patient reported he is still feeling warm since rcvdi...
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Placed follow up called on 4/5/2021 at 1:25pm: Patient reported he is still feeling warm since rcvding 2nd dose on 4/1/2021. Patient also reported on 4/4/2021 there's a sore on the outside of his mouth, and this morning 4/5/2021 the tip of his tongue is red and there is a sore inside his mouth (reporting that there's discomfort inside his mouth when he consume something hard or drink hot beverages). Patient reported on 4/1/2021 in the evening he had high fever (temp 101.9 degree) that occured through Friday morning (4/2/2021), he reported taking Tylenol one time on 4/1/2021 evening and then continued to take Tylenol 3 more times on 4/2/2021. Patient reports that his left armpit is still swollen, and has been swollen for 3 days now, there is pain if pressure is applied to the swollen area. For the swelling in the left armpit patient reported taking Aleve one time on 4/3/2021 but that did seem to help with the swelling. Recommend patient to stay hydrated, and to take Tylenol as need for any fever or pain but not to exceed a dose of 4,000mg per day. Also recommend patient to contact PCP for further evaluation of symptoms. Patient reported will try to get in to see his PCP either 4/5/21 or 4/6/21. Advised will follow up on Wed 4/7/21 after 1pm. Follow up on 4/7/21. Spoke with patient he stated he's feeling a lot better. Fever subsided same day after taking the tylenol. Patient saw PCP on Tuesday 4/6/21 and he was prescribed a steroid. He stated the mouth sores and armpit swelling are 80% better. Patient is overall doing and feeling a lot better. Advised to continue with the medication pcp prescribed and to call if he has any questions or concerns.
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| 53 | 2021-04-07 | pain in extremity, feeling cold | Tired, arm pain, cold, dizzy |
| 53 | 2021-04-08 | cold sweat |
Slight pain in shoulder several hours after injection. By 7:00 am it felt like I had Covid again. ...
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Slight pain in shoulder several hours after injection. By 7:00 am it felt like I had Covid again. I had a fever of 102.8 cold sweats, muscle aches throughout my body and bad headache. I took recommended dose of Tylenol drank tons of fluids and laid in bed the entire next day. what was mild discomfort in shoulder turned into large pain. after about 12 + hours of Tylenol and fluids the fever broke and was down to about 100.6. As of today (Friday) I am up and about with shortness of breath but no fever and minor aches.
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| 53 | 2021-04-08 | nerve pain |
Patient reports new nerve type pain in shoulder. He cannot sleep on that side (left ) and has diffic...
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Patient reports new nerve type pain in shoulder. He cannot sleep on that side (left ) and has difficulty exerting pressure toward his inner body using that arm. Patient has not sought medical attention; he plans to see his chiropractor and possibly his primary medical doctor.
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| 53 | 2021-04-09 | difficulty speaking |
swollen lips; swollen tongue; hoarsness; difficulty swallowing; This is a spontaneous report receive...
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swollen lips; swollen tongue; hoarsness; difficulty swallowing; This is a spontaneous report received from a contactable consumer (Patient). A 53-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot# EL3247), via an unspecified route of administration in the right arm on 10Feb2021 at 3:00 PM (at the age of 53 years-of-old) at single dose for COVID-19 immunization. Medical history included hypertension, hypothyroidism, GERD and tree nuts allergy. Concomitant medication(s) included NEXIUM, PEPCID, QVAR and AMLODIPINE BESYLATE. On 11Feb2021, patient experienced swollen lips, swollen tongue, hoarseness and difficulty swallowing which resulted in emergency room visit. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL3247), via an unspecified route of administration in the right arm on 20Jan2021 at 2:00 PM at single dose for COVID-19 immunization. Therapeutic measures were taken for events which include included Prednisone 50mg/5days and Benadryl. The patient took the most recent COVID-19 vaccine at Workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. The outcome of all the events was recovering.
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| 53 | 2021-04-10 | hot flush |
Fever (+2 degrees above normal); very strong headache, body aches, chills, fatigue, hot flashes, som...
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Fever (+2 degrees above normal); very strong headache, body aches, chills, fatigue, hot flashes, some chest congestion, could not sleep due to aforementioned. Symptoms began about 12 hours after second dose. Symptoms subsided about 24 hours after second dose.
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| 53 | 2021-04-11 | burning sensation |
shingles type rash on right hip about 12" in diameter. same on the middle lower back. took about 7 d...
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shingles type rash on right hip about 12" in diameter. same on the middle lower back. took about 7 days to start to go away, burning itching rashing
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| 53 | 2021-04-11 | muscle twitching |
After my second dose, I experienced muscle twitching exactly in the muscle where I got my shot. It h...
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After my second dose, I experienced muscle twitching exactly in the muscle where I got my shot. It hasn't stop since the then. the muscle twitching wakes me at night and happens almost every 5 minutes till I rubbed it hard. Please help, my insurance deductible is very high and I am out of work to pay for a visit to my doctor.
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| 53 | 2021-04-11 | pain in extremity |
2 am sunday morning I woke up with pain in my left wrist and hand. A blood vessel traveling through ...
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2 am sunday morning I woke up with pain in my left wrist and hand. A blood vessel traveling through my hand and about 3 inches up my left arm felt like a rope to the touch with some swelling between my 3rd and 4th fingers. No redness or hot to the touch. Sunday morning at 9am the blood vessel returned to normal. However Sunday night at 830 pm the swelling and pain and rope like feeling of the same vein returned and the area is the same as of now [2pm Monday the 12th of April ].
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| 53 | 2021-04-12 | bell's palsy |
Facial paralysis/Bell's palsy/lip and tongue paralyzed; Lip and Tongue Paralyzed; reports neck, ear ...
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Facial paralysis/Bell's palsy/lip and tongue paralyzed; Lip and Tongue Paralyzed; reports neck, ear & head pain that started on 21Mar2021; reports neck, ear & head pain that started on 21Mar2021; reports neck, ear & head pain that started on 21Mar2021; This is a spontaneous report from a contactable consumer or other non hcp. A 53-years-old male patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: Batch/Lot Number: unknown; Expiration Date: unknown), dose 1 via an unspecified route of administration on 13Mar2021 between 15:00-16:00 as SINGLE DOSE for COVID-19 immunization. Medical history included diabetes mellitus from 2016 and ongoing States it started 5 years ago, and it is under control, hypertension from 2016 and ongoing States it started 5 years ago, and it is under control. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks. On 21mar2021, the patient experienced neck, ear & head pain on the left side. On 24Mar2021, the patient experienced facial paralysis, lip and tongue paralyzed the left side of the face, bell's palsy. The patient states that everything started before on sunday then on wednesday he started to get paralyzed on his face. The patient went to the ER on 24Mar2021 and they thought he was having a stroke, so they did a CT and MRI and his brain is fin and Stated that the Neurologist diagnosed him with Bells Palsy. He was admitted to the hospital on 24Mar2021 and discharge 25Mar2021 at 18:00. The patient enquired about getting second shot and he wants to know what is going to happen if he gets the second shot, was it recommended or not recommended. The patient underwent lab tests and procedures which included computerized tomogram: normal on 24Mar2021 brain is fine, magnetic resonance imaging: normal on 24Mar2021 brain is fine. Therapeutic measures were taken. The patient was treated with Acyclovir and Methylprednisolone. The outcome of the events facial paralysis, lip and tongue paralyzed were not recovered and for neck,ear and head pain was recovering Information on the lot/batch number has been requested.
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| 53 | 2021-04-12 | pain in extremity |
4/1/2021: SEVERE LEG PAIN, PRESENTED TO HOSPITAL ER AND WAS FOUND TO HAVE ACUTE DEEP VENOUS THROMBOS...
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4/1/2021: SEVERE LEG PAIN, PRESENTED TO HOSPITAL ER AND WAS FOUND TO HAVE ACUTE DEEP VENOUS THROMBOSIS LEFT LOWER EXTREMITY. 4/4/2021: SEVERE SHORTNESS OF BREATH, SQUEAD WAS CALLED AND HE WAS TAKEN TO HOSPITAL ER WHERE HE WAS FOUND TO HAVE BILATERAL PULMONARY EMBOLISM
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| 53 | 2021-04-12 | tremor |
Shaking Chills Body Ache Rapid Heartbeat, my normal is 56-61, during reaction it was 81-88 checked ...
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Shaking Chills Body Ache Rapid Heartbeat, my normal is 56-61, during reaction it was 81-88 checked every hour Fever 99-100.1 Treatment: Fluids, Acetaminophen, Rest
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| 53 | 2021-04-13 | feeling cold | Low fever, cold chills, sweats, headache |
| 53 | 2021-04-13 | muscle twitching, pain in extremity, muscle spasms |
I received 2nd Covid 19 vaccine on April 9th 20201 at 6pm PT. Then I started to have lower back pai...
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I received 2nd Covid 19 vaccine on April 9th 20201 at 6pm PT. Then I started to have lower back pain on Saturday (April 10), but I was still mobile, and was able to perform daily activities. However, on Sunday morning (April 11th), my lower back pain became better, but I started having very severe pain on my left thigh. The pain scale is 10 out 10, and I was unable to move around. I could feel the muscles around the nerve were twitching and cramping, and this gave me such an excruciating pain, and felt like the nerve was squeezed by the thigh muscles. Because of this severe pain, I was not able to mobilize at all on Sunday, then had to go see physician on Monday urgently. The physician was puzzled why I devel
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| 53 | 2021-04-14 | numbness |
Client received the 1st Pfizer COVID vaccine (lot # EW0162 and expiration date: 4/18/21) at 10:11am...
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Client received the 1st Pfizer COVID vaccine (lot # EW0162 and expiration date: 4/18/21) at 10:11am. Client reported numbness in left arm at 10:26am to EMT. Vitals were taken at 10:28am oxygen: 100%, Blood pressure:120/80 and pulse:58. Both Nurses responded to find client alert and oriented x 4. Client reports numbness is localized from injection site to forearm of left arm where injection site is. Client has full mobility and sensation in left arm. Client had already waited 15 minutes, so advised waiting another 15 minutes and since vitals are WNL will get another set of vitals after 15 minutes. At 10:43am retake vitals: pulse: 65, blood pressure: 120/80 and oxygen: 100% and client reports that all symptoms completely resolved. Provided client with ER precautions and do advise primary care provider. At 10:44am client left facility with a steady gait.
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| 53 | 2021-04-14 | numbness |
Face numbness on right side. I started feeling numbness in the right corner of my mouth within minut...
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Face numbness on right side. I started feeling numbness in the right corner of my mouth within minutes of receiving the shot. Within a couple of hours it had spread to a larger area. From just below my eye to my chin including my lips on that side and inside my mouth and cheek. Symptoms were still there the next morning so I contacted my doctor. I was instructed to go to the emergency room. The ER doctor determined that it wasnt a stroke and said it was most likely a reaction to the covid shot. They also said it resembles a minor case of Bell Palsy but was most likely not Bell Palsy. It was probably an inflammation of the nerves in my face due to the shot. I was prescribed a steroid to use if the symptoms did not stop in a couple of days.
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| 53 | 2021-04-14 | tingling, numbness, numbness and pain in extremities |
Numbness tingling internal vibrations in legs feet hands. Neuropathy symptoms in hands and feet star...
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Numbness tingling internal vibrations in legs feet hands. Neuropathy symptoms in hands and feet started after second dose and continues now after 2 1/2 months. Tried course of prednisone minimal improvement
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| 53 | 2021-04-14 | paralysis, pain in extremity |
After first dose, "normal" side effects of extremely sore arm, headache lasting one day. After seco...
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After first dose, "normal" side effects of extremely sore arm, headache lasting one day. After second dose, fever to 101.5 at 1:00am after receiving shot at 3:00pm previous day. Extreme arm and shoulder pain. Waking up again at 3:00am experienced FULL BODY paralysis. Estimate fever at 103+ but was unable to move to verify. Eyes were in pain and blurry vision. unable to reach phone to call 911. These symptoms lasted 1 hour and son called to check on me and rushed over. Fever was at 101 but immediate does of motrin and then later tylenol, broke fever. Arm remained immobile for full day. Now it is mobile but still painful to lift overhead. All other symptoms subsided.
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| 53 | 2021-04-15 | pain in extremity |
Left Arm Pain Approx 5 hrs post vaccination lasting 48 hrs. Headache, shoulder, neck and back muscle...
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Left Arm Pain Approx 5 hrs post vaccination lasting 48 hrs. Headache, shoulder, neck and back muscle aches developing overnight. Fatigue next day (approx 18 through 36 hrs post vaccination), ongoing muscle aches, low body temperature accompanied with chills (96.7-97.7°F) 30-36 hrs post vaccination.
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| 53 | 2021-04-15 | seizure like phenomena |
Patient experienced seizure like activity. EMS was on site to evaluate patient and transported him t...
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Patient experienced seizure like activity. EMS was on site to evaluate patient and transported him to emergency room. Spouse reports frequent seizure activity.
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| 53 | 2021-04-16 | migraine |
A fairly aggressive visual migraine, Episode lasted 15-30 minutes almost exactly 24 hours after inje...
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A fairly aggressive visual migraine, Episode lasted 15-30 minutes almost exactly 24 hours after injection. It would seem there was no mention of migraines as a side affect. So figured it best to report just in case it was a sign of something more. The floaters and flashes were similar to those I have gotten prior to migraine headaches. This was unusual as normally they normally do not interrupt my vision greatly and are simply in my vision and usually only in one eye. In this case it wasn't limited to one eye or one spot.. there were multiple and made it hard to focus and see. Usually when I get visual migraines, a headache comes shortly after. So far as of this writing, I only feel a tinge of a migraine coming on, but it is seeming to fade already. Should note, I do not get migraines often (maybe once every other year or so.. ) and when I do it is usually after extended exposure to the sun and not on a chilly morning when I first wake up. Thus this report.
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| 53 | 2021-04-16 | pain in extremity | Tiredness, fatigue, sore in the arm, fever |
| 53 | 2021-04-17 | weakness, numbness |
15 min after the vaccine patient was released from the pharmacy and exactly 20 min after the vaccine...
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15 min after the vaccine patient was released from the pharmacy and exactly 20 min after the vaccine patient began to experience numbness on the left side of his face and difficulty driving. When he came home he complained of numbness and loss of strength in his left arm and as the next hour progressed he began experiencing numbness in his left hip and decreasing strength in his left hand. I called a medical professional who told me to take him to call an ambulance or take him to the nearest hospital. We arrived at the hospital at 2:30pm and symptoms persisted. By the time we arrived his blood pressure had jumped to 185/114 (This morning before the shot he had self monitored his BP @ 128/80)
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| 53 | 2021-04-17 | weakness |
I felt weak/drained within about an hour of vaccination on April 16. On April 17 I felt pain across ...
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I felt weak/drained within about an hour of vaccination on April 16. On April 17 I felt pain across my body at the level of the skin, including on my scalp. I was extremely cold without a fever, but later developed a fever with e a temperature of 100.7. The symptoms subsided at approximately 5:30 PM on the same day.
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| 53 | 2021-04-17 | feeling hot |
He was hungry all the time and when he ate, he noticed there was no taste at all; When he was tested...
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He was hungry all the time and when he ate, he noticed there was no taste at all; When he was tested for covid he thought he was feeling hot; lost sense of smell; He was hungry all the time and when he ate, he noticed there was no taste at all; Tested positive/tested for covid; fever; Headache; Symptoms in my throat ; This is a spontaneous report received from a contactable consumer. This 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN6206), via an unspecified route of administration at the left arm on 12Mar2021 16:00 at single dose for COVID-19 immunization. The patient's medical history included high blood pressure (Diagnosed more than 5 years ago and is controlled) and diabetes (controlled). Concomitant medications were not reported. On 16Mar2021, the patient had fever, headache and some symptoms in throat. On 18Mar2021, patient was tested positive for Covid19. On 24Mar2021, the patient had lost sense of smell and lost sense of taste. It was reported that he was hungry all the time and when he ate, he noticed there was no taste at all. It was reported that when he tested positive for covid, the doctor gave him an antibiotic and cough syrup. The patient was taking regular medication for blood pressure and diabetes. He had been taking for years and does not fell it is relevant. Now he is taking a lowered dose of his diabetes medication. When he was tested for covid he thought he was feeling hot but had no temperature when verified. Outcome of fever, headache, symptoms in throat, lost sense of smell, lost sense of taste, covid19 was reported as recovered and outcome was unknown for feeling hot and hunger all the time.
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| 53 | 2021-04-21 | cold sweat |
He felt nauseous, got up to go to kitchen sink and passed out for a few seconds. When I got to him,...
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He felt nauseous, got up to go to kitchen sink and passed out for a few seconds. When I got to him, he was on the ground, eyes open, but seriously disoriented. He got up to the couch. He was very, very clammy and his heart rate was 44 bpm. I held three fingers for him to identify, he correctly answered. He has a small gash on his forehead. His heart rate came up to 70, 20 minutes after episode. Refused to go to urgent care.
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| 53 | 2021-04-21 | pain in extremity | Headache Sore arm Nausea Fatigue/Tired |
| 53 | 2021-04-23 | facial paralysis, bell's palsy |
In the late afternoon of April 23rd I started to experience the effects of Bell's Palsy. Droopiness...
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In the late afternoon of April 23rd I started to experience the effects of Bell's Palsy. Droopiness in my lip, eyelid not closing, difficulty in drinking and eating. We went to our local minor emergency center around 4pm and confirmed it was an episode of Bell's Palsy. The Dr prescribed Prednisone and Valtrex. I took the first dose around 6pm. All week long I'd been experiencing a mild headache and had seen the dr the day before. The diagnosis was muscle tension with arthritis in the neck and was assigned to physical therapy.
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| 53 | 2021-04-24 | weakness |
continued muscle pain; skin, hair was hurting, couldn't touch skin; muscular pain down to pelvis and...
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continued muscle pain; skin, hair was hurting, couldn't touch skin; muscular pain down to pelvis and knees aching; muscular pain down to pelvis and knees aching; diarrhea; chills; Fever; sweating; inner-skeletal pain; feeling of dry mouth; slight pain at left shoulder where the injection site was at; headache; Fatigue; weakness and dizziness; weakness and dizziness; sinus drainage; feels dehydrated; This is a spontaneous report received from a contactable consumer (patient). A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration administered in arm left (left shoulder) on 30Mar2021 09:00 (Lot Number: ER8733) at age of 53 years old as single dose for covid-19 immunisation. Patient's medical history (including any illness at time of vaccination) was none. Family medical history relevant to events: caller states he don't think so, his father had high blood pressure and diabetes. Concomitant medication included ibuprofen taken for tooth disorder at 600 mg every 8-12 hours, taking it probably a week before receiving the vaccine. No prior vaccinations (within 4 weeks). No events following prior vaccinations. No additional vaccines administered on same date of the Pfizer Suspect. The patient experienced slight pain at left shoulder where the injection site was at on 30Mar2021, chills on 02Apr2021, fever on 02Apr2021, sweating on 02Apr2021, continued muscle pain on 03Apr2021, skin, hair was hurting, couldn't touch skin on 03Apr2021, muscular pain down to pelvis and knees aching on 03Apr2021, diarrhea on 03Apr2021, fatigue in 2021, headache in 2021, weakness and dizziness in 2021, sinus drainage in 2021, feels dehydrated in 2021. The patient was calling to report some long term, severe side effects. He received the Pfizer covid-19 vaccine on 30Mar2021. He didn't have anything then muscle pain for the first two and a half days, no reaction until on Friday 02Apr2021 he had extreme chills, fever, sweating, then that continued on to be muscle pain, his skin and hair were hurting, couldn't touch skin through Sunday 04Apr2021. It dissipated into muscular and inner-skeletal pain. He had muscular pain down to pelvis and knees and things would start aching. Now it was kind of letting up. It was the 4th day now and no one he knows who had gotten it had such a long term reaction to this. Clarified that he had slight pain at left shoulder where the injection site was at and that dissipated on Thursday 01Apr2021 and he had no pain anymore and no other side effects. On Friday 02Apr2021 afternoon when it went haywire and thought he may have to go to the hospital on Sunday 04Apr2021. He had diarrhea and almost had everything on the list except redness at the site injection. He also did not have swollen lymph nodes. He didn't think he needed to go to the hospital, he normally didn't get sick and hadn't been ill for years and this was why he wanted to report it because it seemed that it was pulling for along time. He had been sleeping and drinking a lot of liquids. Headache, joint pain, and diarrhea continued all the way through Monday 05Apr2021 and started to dissipate Monday evening. He had no nausea and vomiting. The muscular pain down to pelvis started Saturday 03Apr2021. His knee would ache and then that would stop and then his other knee would ache then stop. It was like it would transfer around lower part of body, and that dissipated late Monday 05Apr2021 night into Tuesday (06Apr2021). Now he had fatigue was tired and had sinus drainage. He felt dehydrated and couldn't seem to drink enough liquids to get the feeling of dry mouth out. The diarrhea, fatigue and the sinus drainage was still continuing and the other symptoms seem to have dissipated. He still felt so fatigued and didn't feel the other symptoms are there. He hoped they didn't return. It had stayed the same for the diarrhea, fatigue and sinus drainage and he was still tired. Later added he did have weakness and dizziness, but assumed it was fever and chills. Caller states he did have weakness and dizziness and Saturday 03Apr2021 and Sunday 04Apr2021 were the worst two for all of the symptoms at the same time. It had dissipated as of Monday 05Apr2021 evening. Outcome of weakness and dizziness: Caller initially confirmed it had dissipated as of Monday 05Apr2021. However, he later stated he was still experiencing slightness there. He still feels some weakness, and feels about 60% right now. He thought it would be a good idea to get vaccinated because he had family members that had contracted covid-19 and be less weary of the virus. He was hesitant now to get the second shot. He was taking ibuprofen because he had issues with a tooth. He was taking Benadryl for the sinus and hadn't taken it in 36 hours and hadn't taking anything else. He was already taking Ibuprofen for the tooth issue, but was also using it to relieve some of the symptoms and if it was indeed that he may have contracted something after that. He hadn't been to the doctor but for checks ups in years and years. Time of Onset (24-hour clock): Caller stated it started about 1-2 pm in the afternoon on Friday 02Apr2021 and came on very quickly. The events did not require a visit to emergency room or physician office. The outcome of slight pain at left shoulder where the injection site was at was recovered on 01Apr2021. The outcome of diarrhea, fatigue, sinus drainage was not recovered. No follow-up attempts are needed. No further information is expected.
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| 53 | 2021-04-25 | weakness | Upset stomach, weakness, tiredness, shivers, headache |
| 53 | 2021-04-25 | bell's palsy, facial paralysis, involuntary muscle movements |
reports symptoms of right eye tearing and tongue paresthesia with inabity to drink out of right side...
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reports symptoms of right eye tearing and tongue paresthesia with inabity to drink out of right side of mouth and or grasp straw. reported drooling with right side facial drooping noted on ER visit. Reports that symptoms started approx. on the 16 of Apr and was evaluated on the 23 of Apr for concerns of TIA which was ruled out. Pt was then treated for suspected Bells Palsy with Acyclovir and Prednisone
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| 53 | 2021-04-25 | migraine |
By 3pm a migraine occurred. Migraines continued to cycle for the whole week. Around 4pm-5pm the day ...
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By 3pm a migraine occurred. Migraines continued to cycle for the whole week. Around 4pm-5pm the day of the shot a minor panic attack occurred for about 30 min. No medications were taken for panic attack. Nurtec and Excedrin was taken to deal with migraine attacks along with sleep during course of the week. I was unable to maintain other routine doctor appointments that week as a result.
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| 53 | 2021-04-25 | pain in extremity | swelling and pain in the arm, High blood pressue104/148 |
| 53 | 2021-04-26 | flushing |
Client advised staff that he was feeling faint. Client was given cold water and was seen by EMT. C...
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Client advised staff that he was feeling faint. Client was given cold water and was seen by EMT. Client was red/flushed and seemed dizzy. Client also advised that he was very anxious and worried. Client seem to staff to be very agitated. Nurse suggested deep breathing to calm client. Client was kept in observation for another 10 min.
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| 53 | 2021-04-27 | numbness, tingling |
2 days after vaccine developed parasthesia, numbness of left upper extremity. Persisting and seen to...
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2 days after vaccine developed parasthesia, numbness of left upper extremity. Persisting and seen today 6 days after vaccine.
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| 53 | 2021-04-28 | muscle twitching | I now have a twitching face muscle in my chin. It is not constant but happens frequently every day. |
| 53 | 2021-04-30 | feeling cold |
Fatigue; Sleeping 10-12 hours most nights; felt cold (not chills); This is a spontaneous report from...
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Fatigue; Sleeping 10-12 hours most nights; felt cold (not chills); This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: ER8732), via an unspecified route of administration in the left arm, on 23Mar2021 at 14:15 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included hypogammaglobulinemia immunoglobulin A (IGA) (no IGA present in blood). The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ascorbic acid (VITAMIN C), vitamin D (MANUFACTURER UNKNOWN), cyanocobalamin (VITAMIN B12), and naproxen sodium (ALEVE). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced fatigue, sleeping 10-12 hours most nights, and felt cold (not chills) on 25Mar2021 at 09:30. The events were reported as non-serious. The events were described as: The fatigue set in about 36 hours (as reported) after the vaccine and the patient has been fatigued for 6 days. He has been sleeping 10-12 hours most nights and each day gets a little better. He has felt cold (not chills) and so has been wearing additional clothes, blankets at night and turned up heat in the house. The patient did not receive any treatment as a result of the events. The clinical outcome of fatigue, sleeping 10-12 hours most nights, and felt cold (not chills) was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.
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| 53 | 2021-05-04 | feeling cold, seizure |
Seizure; No recollection of anything that happened between 2000 and 2100 hours; Very foggy, not thin...
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Seizure; No recollection of anything that happened between 2000 and 2100 hours; Very foggy, not thinking properly, repetitive in what he was saying; Very foggy, not thinking properly, repetitive in what he was saying; Very foggy, not thinking properly, repetitive in what he was saying; Not comprehending; He was very cold; Very tired; Very Sweaty; Headache; This is a spontaneous report from a contactable consumer (Patient's wife). A 53-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on 19Apr2021 12:30 (Lot Number: EW0164) as SINGLE DOSE (at age of 53 years old) for covid-19 immunisation. Medical history included ongoing epilepsy diagnosed with this when he was 15 years old, seizure from an unknown date and unknown if ongoing (then at 2015 he had a seizure). Concomitant medications included levetiracetam (KEPPRA) 1250 mg, daily (250mg; 5 pills a day) taken for epilepsy from an unspecified start date and ongoing; carbamazepine (CARBAMAZEPINE) 1000 mg, daily (200mg; 5 pills a day) taken for an unspecified indication from an unspecified start date and ongoing. Family Medical History Relevant to events was none. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 19Apr2021, the patient experienced seizure, Very foggy, not thinking properly, repetitive in what he was saying, very distant, like he was looking at his wife but not seeing her or hearing her, Headache, He was very cold, Very tired, Not comprehending, Very Sweaty, No recollection of anything that happened between 2000 and 2100 hours. The patient received his vaccine yesterday 19Apr2021 at 1230. On 19Apr2021 by 1500 he was very foggy, not thinking properly, and repetitive in what he was saying. He was very distant, like he was looking at the consumer but not seeing her or hearing what she was saying. He was very cold, very tired, and not comprehending. Then at 2015 he had a seizure. She called the paramedics, her husband was very sweaty on 19Apr2021 and that point and had no recollection of anything that happened between 2000 and 2100 hours. Patient was not taken to the Emergency Room or admitted to the hospital. Her husband is completely aware and recovered now. Consumer reported on 19Apr2021 he had a headache that is persisting since the seizure. The consumer reported that her husband is epileptic, but he hasn't had a seizure in over 10 years and hasn't missed any doses of his medication. Patient was evaluated by the Paramedics that came to his home but was not taken to the Emergency Room. Relevant Tests were none. Outcome of Seizure was Recovered/Resolved with Sequel on 19Apr2021. Outcome of Very foggy, not thinking properly, repetitive in what he was saying, He was very cold, Very tired, Not comprehending, Very Sweaty was recovered on 19Apr2021. Outcome of headache was not recovered. Outcome of No recollection of anything that happened between 2000 and 2100 hours was unknown.
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| 53 | 2021-05-10 | muscle spasms |
DVT causing Muscle cramps; DVT causing Muscle cramps; fever; chest pain; This is a spontaneous repor...
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DVT causing Muscle cramps; DVT causing Muscle cramps; fever; chest pain; This is a spontaneous report received from a contactable healthcare professional (patient). A 53-year-old male patient received the second dose of BNT162B2 (lot number: EL9261), intramuscularly in left arm on 03Feb2021 13:00 at single dose for COVID-19 immunisation. Medical history included gout. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (lot number: EL0142), intramuscularly in left arm on 06Jan2021 13:00 for COVID-19 immunisation. The patient experienced deep vein thrombosis (DVT) causing muscle cramps, chest pain, fever, etc 2-3 weeks after the second dose on 24Feb2021 12:00. Patient did not receive any treatment for the adverse events. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was not resolved.; Sender's Comments: Considering a positive temporal association, a causal relationship between the event deep vein thrombosis and suspect drug bnt162b2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
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| 53 | 2021-05-11 | seizure |
Hypo-osmolality and hyponatremia Acute kidney failure, unspecified Unspecified convulsions Hyponatre...
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Hypo-osmolality and hyponatremia Acute kidney failure, unspecified Unspecified convulsions Hyponatremia
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| 53 | 2021-05-16 | numbness, tingling | Numbness, decreased sensation, tingling, loss of mobility in hands and feet |
| 53 | 2021-05-17 | pain in extremity |
My lower extremities, from the knee down, are weak and sometimes it is hard to walk.; My lower extre...
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My lower extremities, from the knee down, are weak and sometimes it is hard to walk.; My lower extremities, from the knee down, are weak and sometimes it is hard to walk.; My knees also hurt; Dizziness; Skin was very pale and cold to the touch.; Profuse sweating.; Fatigue; Muscle Pain; Fainting 9 hours after administration; I had my first headache.; I had pins and needles in fingers 4 and 5 in the arm of vaccine administration; This is a spontaneous report from a contactable consumer (patient). A 53-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 23Apr2021 11:30 (Lot Number: EW0170), at age of 53 years old, at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took asparagus for Allergy. Reported Event: Immediately after the vaccine, I had pins and needles in fingers 4 and 5 in the arm of vaccine administration. 3 hours after vaccine, I had my first headache. Severe headache, dizziness, fainting 9 hours after administration. During fainting episode, skin was very pale and cold to the touch. Profuse sweating. This was on the same day as vaccine administration. For the next 3 days, I laid in bed with fatigue, severe headache, and muscle pain. After 10 days, I still feel weak, I get tired after walking half a mile, and I have episodes of dizziness during the day. My lower extremities, from the knee down, are weak and sometimes it is hard to walk. My knees also hurt. This is still present 10 days after the vaccine. Outcome for events was unknown. Prior to vaccination, whether the patient was diagnosed with COVID-19 Was Unknown, and Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No follow-up attempts are needed. No further information is expected.
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| 53 | 2021-05-19 | bell's palsy | Bell's palsy in left face |
| 53 | 2021-05-19 | tingling |
About 7 hours after my shot I experienced tingling and radiating pain down my left arm from my shoul...
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About 7 hours after my shot I experienced tingling and radiating pain down my left arm from my shoulder to wrist. In the two weeks since my shot my symptoms are getting worse, not better. I used to be able to do two sets of 50 push-ups and I can no longer do one push up. I used to be able multiple sets of 15-20 pull ups for a total of 50 in a couple of minutes. I can no longer do one. I enjoy golf and can no longer play .
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| 53 | 2021-05-21 | weakness, numbness |
Pt states that 10 days ago he had his 1st dose of the Pfizer COVID-19 vaccine. He states that 2 days...
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Pt states that 10 days ago he had his 1st dose of the Pfizer COVID-19 vaccine. He states that 2 days later he had HA, fever, myalgias, weakness, numbness of the hands and fingers, and abdominal pain that lasted a few days. He states the only sx that has persisted is the weakness and numbness of the hands and fingers. The pt states that his arms and legs are equally weak. Pt reports that today he had a fall due to the weakness today, and he denies any head strike or injuries from this fall. MRI of the brain with and without contrast was done showing no acute intercranial abnormality. MRI cervical spine showing no spinal cord abnormality. And MRI T-spine showing no spinal cord abnormality. Lumbar puncture was performed in the emergency room. Protein was found to be elevated at 109. Glucose was elevated at 134 CSF cell count within normal limits. CSF PCR panel within normal limits. Patient continues to complain of weakness. Lumbar puncture was completed showing a protein elevated at 109 likely representing GBS. MRI brain, cervical spine and thoracic spine showing no structural lesion. At this time we will start IVIG 0.4 g/kg daily for 5 days. Patient will be seen by physical therapy and Occupational Therapy. We will also consult inpatient rehab.
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| 53 | 2021-05-23 | pain in extremity | Chest and back pain radiating into right arm |
| 53 | 2021-05-25 | bell's palsy, numbness, tingling |
Bell's palsy-like symptoms: left eye lid drooping, numbness in left check, lips; Bell's palsy-like s...
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Bell's palsy-like symptoms: left eye lid drooping, numbness in left check, lips; Bell's palsy-like symptoms: left eye lid drooping, numbness in left check, lips; Bell's palsy-like symptoms: left eye lid drooping, numbness in left check, lips/ Left shoulder, arm hand numbness and tingling/ Left leg numbness and tingling; Bell's palsy-like symptoms: left eye lid drooping, numbness in left check, lips; Left eye pain and dryness; Left eye pain and dryness; Headache behind eye; Left shoulder, arm hand numbness and tingling/ Left leg numbness and tingling; Elevated blood pressure; This is a spontaneous report from a contactable healthcare professional (patient). A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were unknown) at the age of 53-years-old, intramuscular in left arm on 22Apr2021 at 14:00 at 2nd dose, single for COVID-19 immunization. Medical history was reported as none. The patient has no known allergies. It was unknown if the patient has COVID prior to vaccination. Concomitant medication included macrogol 3350 (MIRALAX). The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided) at the age of 53-years-old, via an unspecified route of administration on 26Mar2021 at 1st dose, single for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was at a pharmacy/ drug store. On 25Apr2021, the patient experienced Bell's palsy-like symptoms: left eye lid drooping and numbness in left check and lips. He also experienced left eye pain and dryness; headache behind the eye; left shoulder, arm, hand, and left leg numbness and tingling; and elevated blood pressure. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment was given in response to the events. The patient underwent lab tests and procedures which included PCR nasal swab for COVID: negative on 15Apr2021 and blood pressure: elevated on 25Apr2021. The outcome of the events was not recovered. Information on the lot/ batch number has been requested.; Sender's Comments: Based on temporal association a contributory role of BNT162B2 to the reported events cannot be totally excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 53 | 2021-05-25 | burning sensation |
Heart Attack, burning from center of chest expanding to back like a dagger and outwards 1 stent plac...
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Heart Attack, burning from center of chest expanding to back like a dagger and outwards 1 stent placed to stop it 2 more stents the next day preventative Now attending cardiac rehab New meds prescribed
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| 53 | 2021-05-25 | muscle spasms, pain in extremity |
Caller reports he had stool that was not fully formed/his stool was liquidy/close to diarrhea; pain ...
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Caller reports he had stool that was not fully formed/his stool was liquidy/close to diarrhea; pain in the arm; Double Vision , massive headaches; Double Vision , massive headaches; Achy and tired, like exhausted after the 2nd shot; Pain at the injection site.; achy/He was achy from joint pain; crampy; He was a little achy and had a headache after the second shot; double visions very disorienting; This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Injection, Batch/lot number: EWO158, expiration date: Jul2021) at left deltoid, in his shoulder on 28Apr2021 15:00 PM at second dose, 0.3 ml single for COVID-19 immunization. Medical history included overweight. Concomitant medication was none. the patient not received other medications within 2 weeks of vaccination. the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received first dose of covid vaccine (Lot number: EWO158) at Arm Left on 07Apr2021 15:00 PM for COVID-19 immunization and experienced diarrhea (since the first dose), worst headache of his life, Pain at the injection site, pain in the arm. Patient experienced double Vision and massive headaches, both on 05May2021 10:00 AM. patient had double vision about a week after the second dose of Pfizer COVID-19 vaccine (Also reported about 15 minutes after the 2nd COVID Vaccine, pending clarification), he read many times people saying it could be such neurological and/or blood clotting, reporter asked if people died from the vaccine. Caller stated he is overweight and afraid of this possible side effects affecting him even more than COVID-19 infection. He asked what about bowel movements or gastrointestinal side effects. He has had close to diarrhea for about 2 weeks now, since the first dose. Caller stated he does not have a Physician. Patient also reported the Headache after the 2nd vaccine was on 28Apr2021. patient reported he is getting a call. Never mind caller is letting it go to voicemail. Caller reports he was distracted but, he is better now. Caller reports he does not get headaches or neurological issues at all, usually. But after getting the 2nd shot, about a week ago from yesterday, he experienced double vision for about 15 minutes. When he got the 1st shot, the Monday after, he experienced the worst headache of his life worse than any hang over. He never had neurological issues and it terrified him because could not shake it right away, it lasted for about 15 minutes then it was gone. He asked if that is something that is a side effect that could be concern and should he be worried about it. Caller reports double vision for 15 minutes. He got the shot at about 10 am. This happened after the 2nd shot. He got the second shot on 28Apr2021. Caller confirms his first shot was on 07Apr2021. Double Vision: It lasted for about 15 minutes and he waited until it came back. It was scary. The double visions very disorienting, he couldn't see anything, he could not work, he could not do anything. For the double vision he just waited it out, by shutting his eyes and laying his head down, it did not work the first few moments but then it did. He was a little achy and had a headache after the second shot. He was achy from joint pain. He took Tylenol before he to went bed and the headache went away. After the first COVID vaccine he experienced the worst headache of his life: It was so bad it knocked him to knees he took Tylenol and it went away. Pain at the injections site, pain in his arm: Started right away after getting the 1st shot. He could not put weight on the arm or without feeling a little pain. After 09Apr2021 he did not notice much after that. Caller said he was achy all over after the first shot when mentioning the arm pain. He asked if this is all experimental right. He wants to find out as much as he can because he does not trust anything online or anyone that is why he called the source, which is Pfizer. Online there are reports from people against the vaccine and for the vaccine. Headache after the 2nd vaccine: He was achy, not as bad as the 12th. It went away on 29Apr2021 he took to some Tylenol before he went to sleep on 28Apr2021. and it went away in his sleep. The Tylenol took care of it. Achy and tired, like exhausted after the 2nd shot: Caller reports the event subsided on 01May2021. Gastro Issues: patient reports he had stool that was not fully formed, not diarrhea and not normal but, runny. It was not formed. He is feeling like he has to go after the second shot on 28Apr2021. It has not subsided yet, it is still kind of going right now. He is not rushing to the bathroom every 5 minutes, but its not comfortable, so its improved since the first time, he was very crampy and his stool was liquidy and now it is more solid, it is slightly improving. 1st Pfizer COVID vaccine Lot number: EW0158; zero maybe an O. he confirms both vaccines have the same Lot number as far as he knows. It is the same Lot on both cards he got. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment received for double Vision. Patient was recovered from double Vision on 05May2021, recovered from headache on 29Apr2021, recovered from Fatigue on 01May2021. Outcome of other events was unknown. It was reported as non-Serious, Seriousness criteria of Results in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating and Congenital anomaly/birth defect were all reported as No. Information on Lot/Batch number was available. Additional information has been requested.
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| 53 | 2021-05-26 | bell's palsy | Bell paulsy left side of my face paralized |
| 53 | 2021-05-27 | seizure |
Seizures back to back to back/cause him to have more seizures; Wetting himself; This is a spontaneou...
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Seizures back to back to back/cause him to have more seizures; Wetting himself; This is a spontaneous report from a contactable consumer (patient's father). A 53-year-old male patient received bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE), dose 2 via an unspecified route of administration on 01May2021 (Lot Number: EW0161; Expiration Date: 31Jul2021) as 2nd dose, single for covid-19 immunization (keep him alive and healthy). Medical history included ongoing sugar (diabetes) that was diagnosed with sugar 15 years ago (2005), heavy (overweight) been heavy for years. (biggest at 250 and is down to 236-238 now. It was stated that he lost weight before the shot and they do not know why), ongoing seizure all his life (he has had seizures all life), cholesterol (blood cholesterol abnormal), son that is special needs and high functioning and on vagus nerve apparatus. The patient received the first dose bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE) via unknown site on 10Apr2021 (Lot number: EW0158) for Covid-19 immunization. Concomitant medication included unspecified medications for seizures and has a VMS (unspecified). The reporter stated that has a son that is special needs and high functioning. The father stated that he has had seizures all life, so he wanted to know if the shot cause him to have more seizures. The father mentioned that he is having seizures back to back to back and wetting himself. The father does not think this has anything to do with the shot, but his mom does. The reporter mentioned that the patient's mom looked online and saw something that stated it causes seizures. The reporter inquired if there were any reports of having seizures for special needs or anybody. He added that the patient had four seizures back to back in his sleep on May2021. The reported further stated that he has an apparatus that was put in his chest that slows the vagus nerve to seizure activity which he has had it since 2004. It was mentioned that that two weeks ago (May2021) when he was with his mom and last night that the seizures started in his sleep. He also was wetting himself which started two weeks ago (May2021) when he was with his mom. The reporter mentioned that he has blood work every 90 days (unknown date) for seizure medications and cholesterol but does not wish to provide (unknown). The father mentioned that the treatment included the patient taking his medication for his seizures as for the wets himself, he got cleaned up and puts fresh clothes on. The outcome of the event convulsions aggravated was recovered on May2021 while the outcome of the other event was recovered on 12May2021.; Sender's Comments: Based on available information the reported seizures and urinary incontinence are unrelated to bnt162b2. These are due to the patient's underlying seizure disorder. Case will be reassessed if additional information is received.
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| 53 | 2021-06-01 | pain in extremity |
THE PATIENT SAID HIS ARM WAS SORE THE DAY HE GOT HIS SHOT. HE SAID 2 TO 3 DAYS LATER IT BECAME REAL...
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THE PATIENT SAID HIS ARM WAS SORE THE DAY HE GOT HIS SHOT. HE SAID 2 TO 3 DAYS LATER IT BECAME REALLY SORE TO THE POINT OF HURTING. HE SAID HE HAS A PHYSICAL JOB AND HE COULD HAVE EASILY INJURED HIS SHOULDER AT WORK THE DAY HE GOT HIS VACCINE, BUT DOES NOT REMBER INJURING ARM/SHOULDER. THE PATIENT PRESENTED TO THE PHARMACY FOR HIS SECOND VACCINE (OVER A MONTH LATER) AND HIS SHOULDER IS STILL HURTING. HE SAYS IT HURTS WHEN HE LIFTS IT UP, IF FEELS WEAK, AND HE HEARS/FILLS A 'POP'.
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| 53 | 2021-06-02 | numbness, tingling, discomfort, muscle spasms |
He was tired; Felt discomfort; Feel numbness and swelling in his toes and hands/feel a numbness on f...
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He was tired; Felt discomfort; Feel numbness and swelling in his toes and hands/feel a numbness on fingers of hand and feet; Feel numbness and swelling in his toes and hands; Began to feel tingling in his back, a sensation that begins as if it were itching becomes a tingling sensation and transforms into a cramp; Began to feel tingling in his back, a sensation that begins as if it were itching becomes a tingling sensation and transforms into a cramp; Inflammation in the stomach; Abdominal pain; Sometimes his blood pressure increases; couldn't sleep with the symptoms; He was not feeling well; He woke up with inflammation in his fingers and toes; This is a spontaneous report from contactable consumer (patient). A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: ER8731 and Expiration date not reported), via unknown route on his right arm on 16Apr2021, (at the age of 53 years) as a 2ND DOSE, SINGLE DOSE for COVID-19 immunization. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: ER8733 and Expiration date not reported), via unknown route in left arm on 26March2021, (at the age of 53 years) as a 1ST DOSE, SINGLE DOSE for COVID-19 immunization. After the first dose patient had only pain in arm. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, patient experienced to feel numbness and swelling in his toes and hands, began to feel tingling in his back, a sensation that begins as if it were itching becomes a tingling sensa-tion and transforms into a cramp, he also presents inflammation in the stomach and abdominal pain for which it has already been prescribed with acetaminophen that calmed his symptoms a little, when he gets wet with hot or cold water feels all the discomfort described previously, he had never felt such symptoms, the patient is concerned that sometimes his blood pressure increases. The patient describes the experience as something similar to an allergy to some food that holds up for a long time and feels that its symptoms have increased, the symptoms diminish when performing his normal activities, today he was unable to work because he woke up with inflammation in his fingers and toes. The patient states, that the timing was normal, he just had the pain as normal, like everyone else getting the vaccine at that time, but with the second it became stronger, but still common with everyone else. Then he started to feel them with much more frequency. Numbness on fingers of hand and feet: the second dose he felt that, alongside the abdominal pain, he was generally not feeling good. He took Acetaminophen and it decreased, when the medication is active, then he goes back to normal, and it increases. Tingling in back started at the same time. At the time it was like itchiness on the back, at that point he wasn't able to scratch but it was fine, then it became tingling that he was not able to get rid of. Inflammation in stomach started with the second dose. The first dose was no issue, he was feeling the same, second dose he had those symptoms. It increases when he drinks milk and stuff so he would say it's getting worse. Blood pressure rises sometimes: He had felt his blood pressure rise since the second vaccine, but it's normal during the day, it was tested and normal, he gets to exercise, that's fine, he has no issues with blood pressure before the second, but for example, early this morning, 12 in the morning to 6 this morning, he felt it was increasing, and he was tired and stuff. outcome normal, his blood pressure fine during day, he exercises, but he felt it early this morning, felt discomfort, he was uncomfortable and tired and now, normally it's fine, regular pressure. reported. The patient describes the experience as something similar to an allergy to some food that holds up for a long time and feels that its symptoms have increased, the symptoms diminish when performing his normal activities, today he was unable to work because he woke up with inflammation in his fingers and toes. After receiving the second dose of vaccination patient felt all these symptoms, took some medication, Acetaminophen because he was not feeling well, yesterday he couldn't sleep with the symptoms. He would visit his doctor after making the report. Patient was working for a pharmacy for 3.5 years. When asked for consent to contact, the interpreter was no longer on the line. Primary care doctor's declined, caller states he doesn't have a PCP, states he is a tourist now. Card has on the back the date, where vaccine was done, states he didn't take any medication; he is very healthy. He took Acetaminophen, clarifies as he took Tylenol (UPC unknown. Lot: SPA084, expiry is Oct2024; strength is 500mg), verified, and he just appreciates the help. Details for Vaccine Supplemental Form not provided by caller. Patient was working in supermarket with friends, they said they would vaccinate people, so he took advantage. The outcome of the events, numbness localized, feel tingling in his back, stomach inflammation, abdominal pain was not recovered, the event blood pressure increases was recovered on unknown date in 2021, the event couldn't sleep, Feel numbness and swelling in his toes and hands, Began to feel tingling in his back, a sensation that begins as if it were itching becomes a tingling sensation and transforms into a cramp not feeling well, couldn't sleep with the symptoms, inflammation in his fingers and toes, he was tired, felt discomfort was unknown. Product complaint was filled: While providing and AE for the Pfizer COVID 19 vaccine, the caller states he had numbness on fingers of hand and feet: He takes Acetaminophen, later clarified as Tylenol, and it decreased, when the medication is active, then he goes back to normal and it increases. Follow up (26May2021): This is a follow up spontaneous report from contactable consumer. This 53-Year-old female consumer (patient) reported for herself new information included event detail, Batch/lot number was updated
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| 53 | 2021-06-02 | pain in extremity |
Arm pain; fatigue; diarrhea; This is a spontaneous report from a contactable consumer (patient, self...
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Arm pain; fatigue; diarrhea; This is a spontaneous report from a contactable consumer (patient, self-reported). A 53-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL9766 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 25Feb2021 at 01:15 PM, as a single dose for COVID-19 immunization at hospital. The patient did not receive any other vaccine in four weeks. The patient's medical history included HIV, rheumatoid arthritis, asthma, and adrenal insufficiency. The patient did not have any known allergies. Concomitant medications were not reported. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. The patient reported that on 26Feb2021, he experienced arm pain, fatigue, and diarrhea. The patient did not receive any treatment for the events. Outcome of the events was recovered on an unknown date. No follow-up attempts are possible. No further information is expected.
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| 53 | 2021-06-03 | numbness |
Whole lip swollen and numb; Whole lip swollen and numb; Nose swollen and numb; Nose swollen and numb...
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Whole lip swollen and numb; Whole lip swollen and numb; Nose swollen and numb; Nose swollen and numb/ Some of his cheek under his left eye was numb; Face had swelled/ some of his cheek under his left eye was numb and swelled; Doesn't feel well, sickness like just don't feel well/ feels sick, kind of; This is spontaneous report received from a contactable consumer (patient himself). A 53-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0186), via an unspecified route of administration on 25May2021 at 14:10 (at the age of 53-year-old) as a single dose to protect him if he would get the coronavirus/ COVID-19 immunisation. The patient's medical history included has something like ALS (amyotrophic lateral sclerosis) (has not been actually diagnosed. Doesn't have anything to do with his lip swelling and nose going numb). No new meds, not anything new eaten, no new detergents. Noting was different other than he got the shot. Has medical conditions but doesn't have anything to do with swelling in lips or face. Patient states he has something like ALS or Lou Gehrig's disease, but has not been diagnosed. It has nothing to do with the swelling or lips turning numb. Concomitant medications were reported as none. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0173), via an unspecified route of administration in left arm on 04May2021 (at the age of 53-year-old) as a single dose for COVID-19 immunization and experienced throwing up four days, sick for four days, slept for 17 hours straight and stayed in bed a total three to four days, tired. Family medical history relevant to adverse events was none. The patient did not administered additional vaccines on same date of the Pfizer suspect. No prior vaccinations (within 4 weeks) within four weeks prior to the first administration date of the suspect vaccine. No adverse events following prior vaccinations. It was reported that, patient was calling about COVID, the Pfizer shot, the second Pfizer COVID shot. Had gotten the shot on Tuesday, 25May2021 at 14:10. Noticed yesterday (26May2021) around 2'clock half of his lip was swelled, and some of nose, and left side of face, cheek, under eye. As time went on it spread. He later clarified it was more around 14:30 after the 24hr period. He noticed his face had swelled, spread over time, and started with his upper left lip. His wife noticed that. Some of his nose was numb and swelled and some of his cheek under his left eye was numb and swelled. It went to other side of his lip, swelled and numb, and his nose was swollen and numb. Both lips are swelled and numb. He went to doctor yesterday, to walk in clinic that was in his doctor's office. They gave him a steroid shot yesterday (26May2021) and steroid pills today (27May2021). He had just taken his first steroid pill now. Confirmed dates and times, he stated the symptoms started after the 24-hour period. Whole lip swollen and numb: Big enough as of right now, that upper lip covers bottom lip, don't even see the bottom lip. Commented he has a sickness like does not feel well. He now feels sick, kind of, not throwing up. No investigation assessment. No relevant tests. No tests performed. Went to walk-in clinic downstairs from doctor's office. The doctor though his symptoms were from the shot and he got a steroid shot and steroid pills. The adverse events required a visit to physician office. The adverse events did not require a visit to emergency room. The outcome of the events was not recovered. Follow-up attempts needed. Additional information has been requested.
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| 53 | 2021-06-03 | night sweats, weakness |
high fever that continued to escalate from Friday night until the Following Wednesday. Intense night...
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high fever that continued to escalate from Friday night until the Following Wednesday. Intense night sweats, intense chills. So weak I couldn't even walk my own dog. Very frightening.
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| 53 | 2021-06-03 | pain in extremity |
Pain in arm; This is a spontaneous report from a contactable consumer (patient) reporting on himself...
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Pain in arm; This is a spontaneous report from a contactable consumer (patient) reporting on himself. A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8733 and expiry date: unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 26Mar2021 as 1ST DOSE, SINGLE for covid-19 immunisation. The patient received the second dose of Pfizer COVID 19 vaccine on 16Apr2021. The patient medical history and concomitant medications were not reported. It was reported that, the patient experienced pain in arm on an unknown date in 2021. The outcome of the event was unknown.
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| 53 | 2021-06-07 | facial paralysis, bell's palsy |
Diagnosed as Bells Palsy on right side of face. Started on 5/24/21 with headache in right side of f...
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Diagnosed as Bells Palsy on right side of face. Started on 5/24/21 with headache in right side of frontal lobe, neck pain slightly below right ear, and right side of tongue being numb. Tongue numbness spread to right, interior side of lips over next few days. On 5/28/2021 I noticed paralysis on right side of face (unable to smile on right side, unable to control direction of spit, unable to wink/close right eye (unless while closing both eyes), unable to furrow brow on right side, unable to keep right side of lips closed when trying to hold breath in mouth (air leakage).
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| 53 | 2021-06-07 | flushing, numbness, tingling |
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unrespo...
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Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Hypotension-Medium, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild
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| 53 | 2021-06-07 | numbness, bell's palsy, facial paralysis | Headache, facial drooping, numbing sensation, 7:30am |
| 53 | 2021-06-07 | tingling, numbness |
THREE DAYS AFTER SHOT, HAVE TINGLING FINGERTIPS ON LEFT HAND, SENSATION ON AND OF FOR COUPLE OF DAYS...
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THREE DAYS AFTER SHOT, HAVE TINGLING FINGERTIPS ON LEFT HAND, SENSATION ON AND OF FOR COUPLE OF DAYS. WEEK AFTER THE SHOT, STABBING PAIN UNDER LEFT ARMPIT ACROSS MIDDLE OF LEFT CHEST. LEFT HAND FEELING NUMB
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| 53 | 2021-06-09 | numbness |
numbness in his fingers/right leg went numb; fog brain; aches and pains; This is a spontaneous repor...
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numbness in his fingers/right leg went numb; fog brain; aches and pains; This is a spontaneous report from a contactable consumer (patient's parent). A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot Number: Unknown) (at the age of 53-years-old) as 2nd dose, single dose for COVID-19 immunisation. Medical history included cardiac pacemaker insertion. The patient's concomitant medications were not reported. Patient was previously administered with first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date (at the age of 53-years-old) for COVID-19 immunisation. The patient said that his son felt no real results from the second dose of COVID-19 vaccine shot but in 2 weeks his son had numbness in his fingers and what his son called fog brain. He said his son also had aches and pains and went to the Emergency Room. The caller said while in the Emergency Room, they drew blood from his son and couldn't find anything. He said his son has been to doctors and his son can't seem to get any help from his symptoms. He said yesterday, his son's right leg went numb. The caller said he was worried for his son and would like some medical help for his son. The patient's mother said they wanted information so her son won't die. The patient's father said his son had read a lot of people who received the COVID-19 vaccine and experienced side effects 2 weeks after the COVID-19 vaccine shot. The patient's father said it was almost exactly 2 weeks after his son received his second COVID-19 vaccine shot that his son experienced his weird problems. Outcome of events was unknown. Information on the lot/batch number has been requested.
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| 53 | 2021-06-10 | pain in extremity | SORE ARM, BIG RED SPOT SOUGHT CARE FROM DERMOTOLIOGIST |
| 54 | 2021-01-06 | weakness |
Date of vaccine 12/7/2020-Patient had very sore painful left deltoid and had to take Tylenol pain le...
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Date of vaccine 12/7/2020-Patient had very sore painful left deltoid and had to take Tylenol pain level 7 out of 10 and interrupted sleeping. 2nd day-12/18/2020-Patient had left sided body weakness, pain at injection site, pain all on left side of body taking Motrin. On 3rd day symptoms all subsided and were gone. No fevers or chills during any symptoms.
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| 54 | 2021-01-06 | weakness |
I woke up the morning after the vaccine with a moderate headache. Felt very tired, no energy. Later ...
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I woke up the morning after the vaccine with a moderate headache. Felt very tired, no energy. Later in the day it seemed as though I had COVID again. Winded very easily, no strength, body aches.
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| 54 | 2021-01-06 | cold sweat | Cold sweats, fever of 100, pain the my joints |
| 54 | 2021-01-06 | numbness | localized swelling, hand/wrist numbness, anxious |
| 54 | 2021-01-07 | tingling |
Subtle tingling left earlobe and left jaw Narrative: Patient complains of occasional tingling "pins...
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Subtle tingling left earlobe and left jaw Narrative: Patient complains of occasional tingling "pins and needles" sensation in left ear, left jaw starting 2 days after vaccination . No other complaints. Has not followed up with physician. States sometimes "it feels like its getting better"
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| 54 | 2021-01-07 | tingling |
RespDepression, Rash, paresthesia extremtiies (>24 hours post vaccine) Narrative: employee developed...
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RespDepression, Rash, paresthesia extremtiies (>24 hours post vaccine) Narrative: employee developed rash/hives 24 hours after vaccine; which progressed over time (initially arms, waist, then torso, face). She also began having shortness of breath. She took otc bendaryl day after vaccine but due to worsening of symptoms, she went to a community ER where she was treated with several doses of IV bendary, steroids, Pepcid, and zyrtec. Her symptoms have improved but she is still taking benadryl and steroid taper.
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| 54 | 2021-01-08 | pain in extremity | pain at injection site, tired, malaise, generalized pain, nausea, runny nose Narrative: |
| 54 | 2021-01-10 | unresponsive to stimuli |
he passed away; not responsive; mind just seemed like it was racing; body was hyper dried; Restless;...
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he passed away; not responsive; mind just seemed like it was racing; body was hyper dried; Restless; not feeling well; ate a bit but not much; kind of pale; Agitated; Vomiting; trouble in breathing; This is a spontaneous report from a contactable consumer (brother of the patient). A 54-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 04Jan2021 (at the age of 54-years-old) as a single dose for COVID-19 immunization. Medical history included diabetes and high blood pressure. Concomitant medications included metformin (MANUFACTURER UNKNOWN) taken for diabetes, glimepiride (MANUFACTURER UNKNOWN) taken for diabetes, lisinopril (MANUFACTURER UNKNOWN), and amlodipine (MANUFACTURER UNKNOWN). The patient experienced not feeling well, ate a bit but not much, kind of pale, vomiting, trouble in breathing, and agitated on 04Jan2021; body was hyper dried and restless on 05Jan2021; mind just seemed like it was racing on 06Jan2021; and not responsive and he passed away on 06Jan2021 at 10:15 (reported as: around 10:15 AM). The clinical course was reported as follows: The patient received the vaccine on 04Jan2021, after which he started not feeling well. He went right home and went to bed. He woke up and ate a bit but not much and then was kind of pale. The patient then started to vomit, which continued throughout the night. He was having trouble in breathing. Emergency services were called, and they took his vitals and said that everything was okay, but he was very agitated; reported as not like this prior to the vaccine. The patient was taken to urgent care where they gave him an unspecified steroid shot and unspecified medication for vomiting. The patient was told he was probably having a reaction to the vaccine, but he was just dried up. The patient continued to vomit throughout the day and then he was very agitated again and would fall asleep for may be 15-20 minutes. When the patient woke up, he was very restless (reported as: his body was just amped up and could not calm down). The patient calmed down just a little bit in the evening. When the patient was awoken at 6:00 AM in the morning, he was still agitated. The patient stated that he couldn't breathe, and his mind was racing. The patient's other brother went to him and he was not responsive, and he passed away on 06Jan2021 around 10:15 AM. It was reported that none of the symptoms occurred until the patient received the vaccine. Therapeutic measures were taken as a result of vomiting as aforementioned. The clinical outcome of all of the events was unknown; not responsive was not recovered, the patient died on 06Jan2021. The cause of death was unknown (reported as: not known by reporter). An autopsy was not performed. The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.; Reported Cause(s) of Death: not responsive and he passed away
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| 54 | 2021-01-11 | feeling cold |
12 hours after the injection. Developed "cold feeling" and muscle aches/join pain. no chills, no fe...
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12 hours after the injection. Developed "cold feeling" and muscle aches/join pain. no chills, no fever. no GI/Resp symptoms. lasting for about 30 hours and resolved completely
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| 54 | 2021-01-12 | pain in extremity |
Fever around 101, ache all over, cough and sore left arm. All symptoms were gone in 24 hours except...
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Fever around 101, ache all over, cough and sore left arm. All symptoms were gone in 24 hours except a cough which lingered until Monday 1/11/2021. Vaccine was given on 1/7/2021.
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| 54 | 2021-01-16 | hot flush, weakness |
1. The first 24 hours (date of vaccination 12/29/2020: Minor Pain at the injection site, minor Hot ...
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1. The first 24 hours (date of vaccination 12/29/2020: Minor Pain at the injection site, minor Hot flashes, Moderate Headache (took Tylenol 1 gm po x 2 doses), lack of energy, anxiety. 2. 01/16/2021 @ 20:00: Swallen Lynph node in left armpit.
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| 54 | 2021-01-18 | unresponsive to stimuli |
Resident received 1st on 1/11/21 at 12:10am (1/12/21) resident was found unresponsive. Code Blue, 91...
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Resident received 1st on 1/11/21 at 12:10am (1/12/21) resident was found unresponsive. Code Blue, 911 called at 12:11am. FD and EMS arrived, resident pronounced at 12:51am.
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| 54 | 2021-01-19 | pain in extremity | sore arm, stomach cramping and diarreah started at 5pm and got worse. |
| 54 | 2021-01-20 | facial paralysis, bell's palsy |
Injection @ 2:47 p.m. on 1/15/21. 1/15/21 around 8 p.m. Bottom lip was swollen. Staff noticed. 1/1...
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Injection @ 2:47 p.m. on 1/15/21. 1/15/21 around 8 p.m. Bottom lip was swollen. Staff noticed. 1/16/21 @ 8:15 a.m. staff viewed swollen lip. Patient reported no pain. 1/18/21 @ approximately 3:00 p.m. - Left eye watering, drooping and visibly swollen. Home health nurse called Dr. No pain reported. Blood sugar 128 and normal. Patient went to ER to be seen as face drooping was worse. ER @ 4:45 p.m. on 1/18/21 - Dr. evaluated and believes he has Bells Palsey. Ordered head CT & labs to verify. Head CT normal ruling out stroke & labs normal. Correlates 60 mg of prednisone daily for one week and 1,00 mg TID Valacyclovir for one week and artificial tears four times daily and cloth tape at night to hold eye lid shut. First doses given in ER at 7:20 p.m. on 1/18/21. 1/21/21 - continue to tape eye at night, all symptoms remain.
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| 54 | 2021-01-21 | weakness | Weak, Dizzy, Dry Mouth & Very Thirsty |
| 54 | 2021-01-21 | flushing |
At time of injection slight chest pain under the arm pit, side of chest, hot flushed feeling shortne...
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At time of injection slight chest pain under the arm pit, side of chest, hot flushed feeling shortness of breath. Hours after injection moderate pain at injection site. Days after injection growing pain at injection site. Weeks after injection a blob of pain and discomfort rising up my left arm into my left shoulder joint and lower neck.
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| 54 | 2021-01-24 | numbness |
Caregiver received vaccine dose at 0900 and about 1100 he described feeling numb all over and dizzy....
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Caregiver received vaccine dose at 0900 and about 1100 he described feeling numb all over and dizzy. Caregiver was taken to St Joseph Hospital via EMS.
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| 54 | 2021-01-25 | burning sensation |
Burn and itching throughout the entire body; Burn and itching throughout the entire body; This is a ...
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Burn and itching throughout the entire body; Burn and itching throughout the entire body; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 54-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3302) via an unspecified route of administration in the left arm on 11Jan2021 10:30 AM at a single dose for COVID-19 immunisation. Medical history included diabetes and known allergies to peanuts. Concomitant medications were not reported. The patient previously had known allergies to amoxicillin. The patient experienced burn and itching throughout the entire body on 11Jan2021 which resulted to emergency room/department or urgent care. Treatment for the events included Benadryl. The patient had no COVID prior to vaccination. He did not have COVID tested post vaccination. The patient had no other vaccine in four weeks. The outcome of the events was recovering.
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| 54 | 2021-01-29 | tingling |
9 days after the vaccination, I had fever 102-103 F with chill, malaise, paresthesia and body ache r...
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9 days after the vaccination, I had fever 102-103 F with chill, malaise, paresthesia and body ache requiring taking Tylenol alternate with Advil every three hours. I tested for COVID-19 (PCR) and it was negative. Fever continued. On day 6, I went to urgent care center and was tested again with PCR for SAR-CoV-2 virus. The result was again negative. On day 7, I started coughing so I went to Hospital ER and was admitted. Chest X-ray and CT scan of chests showed pneumonia. The COVID-19 PCR test was again done and was negative. Respiratory panel PCR was negative. Mycoplasma titer was negative. I was given steroid and fever improved. I continued to cough until now (1/30/2021)
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| 54 | 2021-01-31 | weakness |
ON THE THIRD DAY POST VACCINATION PT WOKE UP WITH HEAD ACHE, WEAKNESS, BODY ACHES, THE 4TH DAY START...
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ON THE THIRD DAY POST VACCINATION PT WOKE UP WITH HEAD ACHE, WEAKNESS, BODY ACHES, THE 4TH DAY STARTED DRY COUGHING , SORE THROAT, ON THE 5TH DAY BEGAN WITH COUGH AND YELLOW SPUTUM. BODY ACHES, FATIGUED
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| 54 | 2021-01-31 | tingling, muscle spasms |
Uncontrolled short rhythmic breathing; brief electric shock sensation; little sporadic back spasms; ...
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Uncontrolled short rhythmic breathing; brief electric shock sensation; little sporadic back spasms; strong head pressure sensation; depression symptoms; This is a spontaneous report from a contactable Other HCP reporting for self. A 54-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 07Jan2021 09:00 at single dose for covid-19 immunisation. The patient medical history was not reported. Patient received first dose of bnt162b2 on 17Dec2020 09:00. The patient's concomitant medications were not reported. The patient experienced Uncontrolled short rhythmic breathing, brief electric shock sensation and little sporadic back spasms, strong head pressure sensation, depression symptoms currently persistent and decreasing gradually on 09Jan2021. Patient had Nasal Swab on 12Jan2021 with negative result. Outcome of events was recovering. Patient received treatment for all events.
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| 54 | 2021-02-02 | seizure, facial paralysis, one side paralysis, weakness |
Patient is noticed to have generalized weakness, holding his head towards right side, mild right fac...
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Patient is noticed to have generalized weakness, holding his head towards right side, mild right facial puffiness with mild left facial droop, and sent to ER, on 1/22/21. Patient also had mild fever for the last two days and was on Tylenol, blood pressure also remained elevated moderately than the usual readings. Patient was admitted through ER for 2 days and was discharged on 1/24/21, with a diagnosis of possible TIA, Todd's paresis post seizure. Patient's CT head and MRI of brain was negative for acute stroke. Patient's left facial droop and right side facial puffiness resolved over a week but noticed to have right sided pronounced weakness with moderate swelling on right arm. Patient used to eat by himself,but now not able to do so and not able to hold cup in the right hand. Patient was again sent to ER for repeat CAT scan of head, further evaluation and management. Not sure if patient had an adverse reaction to Covid-19 vaccination, but definitely these symptoms were developed after 2 weeks of receiving Pfizer vaccination, which may be coincidental. Patient was followed up by the neurologist a week after the discharge from hospital who couldn't rule out adverse reaction of vaccination. Patient is awaiting for an EEG, carotid ultrasound and Echo as an out patient.
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| 54 | 2021-02-03 | pain in extremity |
He had a secondary infection of bronchitis; positive COVID-19 test with symptoms; positive COVID-19 ...
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He had a secondary infection of bronchitis; positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; sore arm; headache; This is a spontaneous report from a contactable consumer (patient). A 54-years-old male patient started to receive the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL1284), via an unspecified route of administration in the right arm on 30Dec2020 14:40 at single dose for COVID-19 immunisation. Medical history included hypothyroidism and blood cholesterol, both ongoing. The patient received the influenza vaccine on 04Nov2020. Concomitant medication included levothyroxine sodium (SYNTHROID), eicosapentaenoic acid ethyl ester (VASCEPA). On 31Dec2020 the patient experienced sore arm and headache with outcome of recovered on 01Jan2021. On 02Jan2021 and 03Jan2021 he felt fine. He had a scratchy throat on Monday 04Jan2021. Tuesday 05Jan2021 he felt like he was getting bronchitis which he got sometimes. Later that evening on 05Jan2021 he had a two degree temperature, chills, and achy muscles. He couldn't get in with the doctor on 05Jan2021, so he had to wait until 06Jan2021 when he went to the respiratory clinic. They did the COVID test on 06Jan2021, but the positive result didn't come back until 07Jan2021. He was just now recovering from it. He had a secondary infection of bronchitis and was given an inhaler.
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| 54 | 2021-02-04 | pain in extremity |
Sore arm; This is a spontaneous report from a contactable consumer. A 54-year-old male patient recei...
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Sore arm; This is a spontaneous report from a contactable consumer. A 54-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EL9262), via an unspecified route of administration on 20Jan2021 19:00 at SINGLE DOSE at right arm for covid-19 immunisation. Medical history included Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medication included tamsulosin hydrochloride (FLOMAX), atorvastatin (LIPITOR), duloxetine hydrochloride (CYMBALTA), varicella zoster vaccine rge (cho) (SHINGRIX). On 21Jan2021 02:00, the patient experienced sore arm, normal effect with most shots. The patient did not receive treatment for the adverse event. The outcome of the event was recovering.
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| 54 | 2021-02-09 | feeling hot |
3 days after the vaccination, started with shortness of breath, and dysphony. The shortness of breat...
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3 days after the vaccination, started with shortness of breath, and dysphony. The shortness of breath gets worse walking on stairs and the dysphony worsens when talk. I also noted a hotness sensation, but when used the thermometer the temperature was normal. When checked both lungs didn't have any abnormal sounds. On the absence of these symptoms, I started using Fluticasone with Salmeterol, that improved the shortness of breath, but it came back after 12-14 hours, requiring use of 2 inhalations mornings and nights, the dysphony was related to the hotness and light tiredness. I used the medicines from January the 16th to February 6, when noticed that the shortness of breath improved and didn't required the dose for the night, then stopped the dose for the morning. Regarding the hotness sensation, is still present but the dysphony disappeared.
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| 54 | 2021-02-11 | burning sensation |
Itchy, burning, hot rash over chest, clavicles, and neck. Spreading slowly and have had for over a ...
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Itchy, burning, hot rash over chest, clavicles, and neck. Spreading slowly and have had for over a week.
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| 54 | 2021-02-11 | feeling cold |
Patient woke up at 3:00 AM freezing and sweating with a bad headache. Chills and sweating stopped by...
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Patient woke up at 3:00 AM freezing and sweating with a bad headache. Chills and sweating stopped by 7:00 AM but slept for a majority of the day due to headache persisting.
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| 54 | 2021-02-12 | feeling hot |
Patient received his first COVID-19 vaccine on 2/12/2021 at approximately 11:30am at clinic. He is a...
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Patient received his first COVID-19 vaccine on 2/12/2021 at approximately 11:30am at clinic. He is a resident there. He was initially monitored for 30 minutes without incident. Approximately an hour later (12:30pm) he returned complaining of sweating, feeling warm (no fever, normal blood pressure) and blurry vision. He was monitored for an additional 30mins (approximately 1pm). Symptoms did not resolve. The facilities manager called EMS and patient was taken to Hospital. No further information available at this time.
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| 54 | 2021-02-13 | weakness |
Broke out in hives approximately 1 hour 30 minutes after injection. Severe weakness, body aches, fev...
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Broke out in hives approximately 1 hour 30 minutes after injection. Severe weakness, body aches, fever, and fatigue began approximately 20 hours after injection
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| 54 | 2021-02-16 | numbness and pain in extremities | vagus nerve neuropathy - began one month after vaccine; dysphagia; vocal cord partial paralysis |
| 54 | 2021-02-26 | difficulty speaking | Tightness in throat/chest; difficulty breathing; hoarse voice. |
| 54 | 2021-02-26 | pain in extremity |
Significant pain and lack of mobility in left arm. Much more pain and limited mobility than is "regu...
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Significant pain and lack of mobility in left arm. Much more pain and limited mobility than is "regular" post vaccine. Note that the injection site seems very high relative to "standard."
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| 54 | 2021-02-27 | weakness, tremor |
Headache 24 hours after injections Overall tired and weak 48 hours after injection Tremor in left t...
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Headache 24 hours after injections Overall tired and weak 48 hours after injection Tremor in left thumb at 48 hours and continues currently at about 72 hours post
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| 54 | 2021-03-01 | feeling hot, sensory loss |
tunnel vision; warm sensation travel from the left shoulder area to my chest/upper stomach; eyes bur...
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tunnel vision; warm sensation travel from the left shoulder area to my chest/upper stomach; eyes burned; could taste something; heart rate became rapid at a steadily increase amount (113 bpm)/pulse stayed at 92-94 BPM for approximately two hours; felt dizzy; lost speed sensation in the car I was driving; This is a spontaneous report from a contactable consumer (patient himself). A 54-year-old male patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EN6201), via an unknown route, on 12Feb2021 (at 12:45) at a single dose in the left arm for COVID-19 immunisation. No other vaccine was received in four weeks. Relevant medical history included atrial fibrillation from Jun2020, ablation surgery for atrial fibrillation on unknown date, ongoing atrial tachycardia, and ongoing premature ventricular contractions (PVCs). Past drug history included allergy to penicillin. Relevant concomitant medications included vitamin NOS, mineral NOS (MEGA MEN) and amino acids NOS, carotenoids NOS, herbal NOS, hyaluronic acid, methylsulfonylmethane, minerals NOS, vitamins NOS (GNC MEGA MEN SPORT). Within approximately two minutes of receiving the shot, he felt a warm sensation travel from the left shoulder area to his chest/upper stomach, his eyes burned, he could taste something, and his heart rate became rapid at a steadily increase amount. He watched his heart rate tick up on her watch to approximately 113 BPM. His normal resting heart rate was upper 60s. He felt dizzy and out of it for about 30 minutes. He felt like he had tunnel vision and lost speed sensation in the car he was driving. His pulse stayed at 92-94 BPM for approximately two hours. He wasn't anxious about getting the shot and had actually been looking forward to it. The patient was not treated for the events. The patient had recovered from 'felt dizzy' on 12Feb2021 while the remaining events resolved in Feb2021.
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| 54 | 2021-03-02 | tingling |
Pfizer-BioNTech COVID-19 Vaccine EUA Tingling on Left side of body, in the area between the top of s...
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Pfizer-BioNTech COVID-19 Vaccine EUA Tingling on Left side of body, in the area between the top of shoulder to left side neck area. Tingling occurs 4 to 5 times daily. No pain to report or server discomfort. Reported to my primary physician
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| 54 | 2021-03-03 | bell's palsy |
Diagnosed with Bell's Palsy on 19Feb2021; This is a spontaneous report from a contactable healthcare...
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Diagnosed with Bell's Palsy on 19Feb2021; This is a spontaneous report from a contactable healthcare professional (patient). A 54-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number and expiration date were unknown), via an unspecified route of administration at the right arm on 06Jan2021 at a single dose for COVID-19 immunization. The vaccine was administered to the patient at a hospital. The patient had no COVID prior to vaccination. The patient's medical history was not reported. Concomitant medication included lisinopril and metoprolol. The patient had no other vaccine in four weeks. The patient was diagnosed with Bell's Palsy on 19Feb2021 (start of event was reported as 19Feb2021 at 06:15 AM). The event resulted in doctor or other healthcare professional office/clinic visit. The patient had COVID test post vaccination which was a nasal swab with unknown results on an unspecified date in 2021. Therapeutic measures were taken as a result of event Bell's Palsy which included unspecified medication. The outcome of the event was not recovered. Information on the lot/batch number has been requested.; Sender's Comments: The possibility that suspect drug may have contributed to the reported event cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 54 | 2021-03-05 | feeling hot, flushing |
Heart started to race, face flushed, sweaty forehead and palms, felt hot. lasted approx 1 min, and...
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Heart started to race, face flushed, sweaty forehead and palms, felt hot. lasted approx 1 min, and slowly went away after 5min or so.... I did not notify anyone.
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| 54 | 2021-03-07 | pain in extremity |
Severe burning pain from neck down to wrist on injection arm. Pain started on 3/5, about 16 hours a...
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Severe burning pain from neck down to wrist on injection arm. Pain started on 3/5, about 16 hours after injection and is ongoing as of today (3/08).
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| 54 | 2021-03-08 | feeling hot |
Couple of episodes of feeling like i was getting sick. lasting a hour or so. (run down, warm). Had ...
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Couple of episodes of feeling like i was getting sick. lasting a hour or so. (run down, warm). Had a rash brake out. Mainly on torso, some on other body areas. Have been on for 6 days now.
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| 54 | 2021-03-10 | tremor |
Severe stomach cramps; Severe diarrhea; He felt like he was running a fever; Chills; Sweats; Shakes;...
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Severe stomach cramps; Severe diarrhea; He felt like he was running a fever; Chills; Sweats; Shakes; This is a spontaneous report from a contactable consumer (Patient) from a Pfizer-sponsored program. A 54-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL8982), intramuscular on 02Feb2021 at around 10:00 (at the age of 54-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history was not reported. The patient had a family history of dementia. Concomitant medications were not reported. The patient did not receive other vaccines within 4 weeks prior to vaccination. About 36 hours after getting the vaccination (unknown date Feb2021), the patient experienced severe stomach cramps, severe diarrhea, felt like he was running a fever, chills, sweats, and shakes. The clinical outcome of the stomach cramps, diarrhea, fever, chills, sweats and shakes was recovered on an unknown date in Feb2021 (symptoms lasted about 18-24 hours).
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| 54 | 2021-03-14 | pain in extremity |
sore arm with both shots; Caller stated that he had an antibody test on 05Feb2021 and the test was n...
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sore arm with both shots; Caller stated that he had an antibody test on 05Feb2021 and the test was negative.; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect from a contactable physician (patient). A 54-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 29Dec2020 (first dose, lot number: EK5730) and 19Jan2021 14:00 (second dose, lot number: EL3248) both in left shoulder at 0.3 mL, single for prevention. The patient medical history was not reported. There were no concomitant medications. He had 2 doses of covid vaccine with no side effect. 15 days later, he had antibody test on 05Feb2021 and the test of IgM and IgG basically were negative. He had no antibodies to the coronavirus. So he was not sure whether or not he got a vaccine that was too old, not taken care of properly, but he had no immune response 15 days after the second dose he should have developed a response, developed antibodies. He was inquiring if that was effective and wanted to know if he should get another antibody test and take another dose of the Pfizer vaccine or get the Moderna vaccine. The patient stated seriousness as it was serious, it did not require hospitalization, he was not ill at least and had been self-isolating very well, but he was thinking long term, he was feeling well, had no problems, no complications related to the vaccine, other than a sore arm with both shots, that's it, it went smoothly, it was serious, he hoped to have some protection, but was concerned he had none. The patient had sore arm with both shots. The outcome of event antibody test negative was not recovered and event sore arm was unknown.; Sender's Comments: It was noted that patient had antibody test and the test of IgM and IgG basically were negative. He had no antibodies to the coronavirus. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
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| 54 | 2021-03-16 | tingling |
Ten minutes after receiving his vaccination, he developed lightheadedness, vision changes (? vision...
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Ten minutes after receiving his vaccination, he developed lightheadedness, vision changes (? vision became cloudy?) , paresthesias in bilateral upper extremities. He was able to sit back down. No falls or trauma to his head or any part of his body. He was placed on a stretcher to a private section of the arena and monitored. Initially, his blood pressure was 103/69, and interval blood pressure 20 minutes later was 139/73. He was given water to drink, which he tolerated. He reports that he has similar reactions to needles in the past, but the current presentation is longer than usual (symptoms usually resolve in five minutes). He was able to recover from the symptoms after 25 minutes of monitoring.
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| 54 | 2021-03-17 | night sweats |
36 hours after the vaccine, I don't know if it was the vaccine or what, but I had BODY PAIN CHILLS A...
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36 hours after the vaccine, I don't know if it was the vaccine or what, but I had BODY PAIN CHILLS AND FEVER OF 99.08 FOR A DAY OF FEVER. FROM MARCH 15 TO MARCH 16. AND FOR THREE NIGHTS IN A ROW I AM SWEATING A LOT OF WET MY T-SHIRTS AFTER SLEEPING 2 OR 3 HOURS I CHANGE THEM FROM 3 TO 4 TIMES AT NIGHT, IT IS ONLY AT NIGHT NOT IN THE DAY, I NEVER SLEEP IN THE DAY. I'M CONCERNED BECAUSE I HAVE AN APPOINTMENT FOR 03/04/2021
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| 54 | 2021-03-18 | cold sweat |
Received Vaccination @1030Am. PT felt faint and Clammy, 1037AM. Staff lied PT down. Pt was transf...
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Received Vaccination @1030Am. PT felt faint and Clammy, 1037AM. Staff lied PT down. Pt was transferred to wheelchair, given water. PT began to feel better. Left @ 1105AM.
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| 54 | 2021-03-18 | flushing |
Flushing erythematous macular rash over neck and upper torso, pt felt warm and flushed No treatment...
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Flushing erythematous macular rash over neck and upper torso, pt felt warm and flushed No treatment, 30min observation Rash was not improved or worsening after 30 min, pt was released with ER precaution
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| 54 | 2021-03-18 | pain in extremity | BODYACHES, ARM SORENESS, CHILLS |
| 54 | 2021-03-18 | pain in extremity |
Sore arm; headache; This is a spontaneous report from a contactable consumer (the patient). A 54-yea...
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Sore arm; headache; This is a spontaneous report from a contactable consumer (the patient). A 54-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6200), via an unspecified route of administration in the left arm on 17Feb2021 15:30 (at the age of 54-years-old), as a single dose for COVID-19 immunization. The patient's medical history included: hypertension and high cholesterol. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified concomitant medications. The patient previously had allergies to topical iodine- produces rash. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Feb2021 16:00, the patient experienced sore arm and headache. No treatment was received for the events. The clinical outcome of sore arm and headache was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 54 | 2021-03-19 | tenderness |
Very soon after I left the parking lot after waiting 15 min for observation ( i was literally 15 sec...
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Very soon after I left the parking lot after waiting 15 min for observation ( i was literally 15 sec after ) I started to feel an slight painful tingling in the corner of my mouth on my lips I thought it was like a chapped lip it progressed to my full set of lips and it was tingling and slight painful to touch maybe slight swollen but not a lot I then started to clear my throat and felt like my mouth was very dry like a lump in the back of my throat i was slightly having little difficulty in feeling could not catch my breath and considered going to the closest hospital i was getting a little worried so that may have been the cause of resp issue It started to improve and i drove home and in about 10 to 15 mins all the symptoms were gone and i am symptom free now about 24 hours later
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| 54 | 2021-03-21 | sensory loss, numbness, weakness |
3 days after receiving vaccine #1 I experienced: - Dizziness - Very unbalanced when trying to stand...
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3 days after receiving vaccine #1 I experienced: - Dizziness - Very unbalanced when trying to stand or walk - Right side extremities hand, arm, leg, foot were numb with loss of sensitivity and strength
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| 54 | 2021-03-22 | weakness |
It feels like I burnt my tongue. Because of that nothing tastes the same Still going on 3/23/21 1...
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It feels like I burnt my tongue. Because of that nothing tastes the same Still going on 3/23/21 10:54 AM Low fever 99.9 for a couple of days Headache, on going 3/23/21 10:54 AM Little dizzy and weak on going 3/23/21 10:54 AM Nothing horrible just uncomfortable
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| 54 | 2021-03-22 | muscle spasms, weakness | chills, fatigue, weakness, diarrhea cramping swollen glands |
| 54 | 2021-03-23 | unresponsive to stimuli, pain in extremity |
Within minutes of patient receiving vaccine, patient began to feel lightheaded and skin color began ...
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Within minutes of patient receiving vaccine, patient began to feel lightheaded and skin color began to turn white. Patient parked by EMS in observation parking and became unresponsive. EMS began vital signs and tried to get him to wake up. Patient stayed unresponsive and vital signs continued to decline. EMS transported patient to hospital. Upon arrival to hospital, staff conducted EKG, chest x-ray, and blood work. All tests came back normal. Patient began to become coherent, and staff began to try and feed him and get him up. After patient was able to get self up and eat food, he was sent home. Patient is now at home recovering. He states he only feels a sore arm and is fatigued.
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| 54 | 2021-03-24 | feeling hot | Pt c/o lip swelling and feeling warm, Ice pack given, and Benadryl 50 mg Orally given, Pt sent home |
| 54 | 2021-03-25 | inability to speak | headache, nausea, vomiting 15 minutes after vaccine. Trouble speaking/remembering -- EMS transfer |
| 54 | 2021-03-26 | burning sensation |
Starting the following day after the vaccine a rash appeared on the whole body, arms legs feet. Rash...
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Starting the following day after the vaccine a rash appeared on the whole body, arms legs feet. Rash was treated with some medication throat started swelling, mild headache and burning sensation all over body.
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| 54 | 2021-03-27 | cold sweat, inability to speak |
Woke up with vertigo, nausea and cold sweats. Could not speak for about 10 minutes. Crawled to bath...
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Woke up with vertigo, nausea and cold sweats. Could not speak for about 10 minutes. Crawled to bathroom on stomach and vomited. After laying on floor, was able to speak and crawled back to bed. Vomited one more time around 10 am. Was in bed until 4:00 pm. Symptoms subsided by then, but I did not feel well until the next morning. The vertigo and nausea were the most severe I have ever had. At no point was I running a fever..
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| 54 | 2021-03-29 | weakness |
Adverse events experienced and are they still occurring now: Had chills, aches, fever of 101 and a ...
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Adverse events experienced and are they still occurring now: Had chills, aches, fever of 101 and a cough. She is still feeling weak and has a cough What happened as a result of the adverse event? (doctor visit, ED or urgent care visit, hospitalization, life threatening illness, disability/permanent damage, death, none of these): Home management and has been taking Tylenol once or twice a day
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| 54 | 2021-03-29 | tingling | Pins and needles pain everywhere, even my eyelids |
| 54 | 2021-03-29 | tremor |
Dolor en sitio de injeccion Escalorfrios Dificultad al respirar Un corazon acelerado Mareos severos,...
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Dolor en sitio de injeccion Escalorfrios Dificultad al respirar Un corazon acelerado Mareos severos,cerca del desmayo, debilidad Temblores en las manos y brazos. Duracion del Evento: Aproximadamente, 1h y 30 mins
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| 54 | 2021-03-31 | muscle spasms |
received dose one of vaccine on Sunday around 6pm. On Monday evening I started to have some lower b...
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received dose one of vaccine on Sunday around 6pm. On Monday evening I started to have some lower bowel or intestine pain. It got worse through the night and had bad cramping in morning. I tried going BM and could not. After getting up and moving around a bit I was able to have a solid stool, but it did hurt a little. It also hurt when I went to urinate. Later that day I had 99 to 100 fever. For the next 2 days I was better but I did have some lower abdominal pain and tenderness.
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| 54 | 2021-03-31 | pain in extremity |
Sore arm, nighttime chills during sleep, headache, fever (99.7). Sore arm started 3 hours after sho...
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Sore arm, nighttime chills during sleep, headache, fever (99.7). Sore arm started 3 hours after shot and the others about 15 hours after shot.
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| 54 | 2021-04-01 | weakness, pain in extremity |
Within approximately a couple of days from the first of two COVID19 Pfizer injections, I developed a...
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Within approximately a couple of days from the first of two COVID19 Pfizer injections, I developed a progressive, systemic, neuro/neuro-muscular inflammatory pain response. The inflammation and pain first manifested in my left wrist and hand, greatly worsening recent symptomology that may have been the start of a carpal tunnel syndrome. The inflammation and pain then progressed to my right wrist and hand and right shoulder. Then they progressed to my left shoulder, under my clavicles, my hips, and my upper lumbar/lower thoracic region of my spine. Muscle groups tightened and hurt, chief among them my hamstrings and upper back. All within days. The inflammation and pain were severe, especially from the early a.m. (3 or 4 in the a.m.) to waking hours. And the conditions left me nearly debilitated and incapable of sleeping well or performing many ADLs. Then, on Monday, March 29, 2021, I saw an orthopaedic for the pains in my wrists and hands, and he prescribed me a steroid for a preliminary diagnose of bilateral carpal tunnel. The inflammation and pain throughout my body decreased considerably after only two doses of the steroids. That led me to seek a consultation with the rheumatologist.
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| 54 | 2021-04-01 | flushing |
Hypertensive Crisis, chest pain, facial flushing which is still occuring. Went to ER at 12:15 am on ...
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Hypertensive Crisis, chest pain, facial flushing which is still occuring. Went to ER at 12:15 am on 3/17/2021. Treated with Labetatol.
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| 54 | 2021-04-03 | numbness |
During early morning hours I awoke with pain and swelling at injection site, and hand and fingers we...
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During early morning hours I awoke with pain and swelling at injection site, and hand and fingers were numb util effectively exercised a few minutes. Shortly thereafter, I developed a sever headache along with fever, chills and lethargy. Sever body aches followed with joint pain throughout entire body. All symptoms lasted 24-36 hours. 48 hours later, still feeling stiff with aching back muscles and feeling tired. Large underarm lumps have developed 72 hours after injection. All of the aforementioned occurred after the second injection.
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| 54 | 2021-04-04 | bell's palsy |
Bell's Palsy (House-Brackmann grade IV) developed on 4/4/21, 17 days after administration of the fir...
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Bell's Palsy (House-Brackmann grade IV) developed on 4/4/21, 17 days after administration of the first Pfizer Covid=19 dose. Pt was started the next day (today) on prednisone and valacyclovir.
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| 54 | 2021-04-04 | pain in extremity |
I woke the morning after not feeling the best. About 10:00 am or so, I started getting achy all over...
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I woke the morning after not feeling the best. About 10:00 am or so, I started getting achy all over my back and shoulders. It got worse over next few hours and stayed with me all evening. Had a headache as well. The next morning I was 80% better and by the next morning I was fine. The pharmacist told me that most people only get sore arm and sometimes can hardly lift the arm. I had sore arm but nothing I couldn't deal with. He also said that second shot tends to make people sick. I guess I wanna be certain I should get second vaccine?! I tested positive for covid on 12/20/20 and negative on 1/8/21.
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| 54 | 2021-04-04 | tingling |
Recv'd first shot 4/3/21, was fine 4/4/21. Early in AM of 4/5/21 I had muscle aches, stomach crampin...
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Recv'd first shot 4/3/21, was fine 4/4/21. Early in AM of 4/5/21 I had muscle aches, stomach cramping, and chills. At 1 point I stopped working because I felt tingly, and started to sweat (only happened once). I'm feeling tired, like I have the flu.
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| 54 | 2021-04-05 | weakness | Hives/rash on the whole body Fever on second day with headache and weakness |
| 54 | 2021-04-05 | tingling |
After receiving his vaccine, client stated he have headache, tingling sensation in L side of his fac...
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After receiving his vaccine, client stated he have headache, tingling sensation in L side of his face. No vital signs obtained by EMS. Client refuse vital signs as per EMT. Client states he is feeling better. Client discharge home.
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| 54 | 2021-04-06 | hot flush |
After 1st covid injection, Pt states felt shaken. Went to ER. Had hot & cold flashes, arm pain. Bega...
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After 1st covid injection, Pt states felt shaken. Went to ER. Had hot & cold flashes, arm pain. Began to feel better after waiting in ER. Saw Dr . Vitals ok and pt released home. Pt states ok now just tingling in hands.
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| 54 | 2021-04-06 | numbness, pain in extremity |
Extreme flair up of joint pain. Worst in one hip/leg on the level of pain of a kidney stone. Could n...
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Extreme flair up of joint pain. Worst in one hip/leg on the level of pain of a kidney stone. Could not walk without extreme pain or go down set of stairs. Has improved some but now also experiencing moderate pain in other leg and feet are numb
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| 54 | 2021-04-06 | pain in extremity |
Full body aches, arm pain, 100F fever, neck and headache and sinus pressure. All subsided after 16 ...
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Full body aches, arm pain, 100F fever, neck and headache and sinus pressure. All subsided after 16 hrs from onset.
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| 54 | 2021-04-07 | tremor | Became cold and then violent shaking that lasted 2 1/2 hours |
| 54 | 2021-04-08 | weakness |
Headache; Body aches; Light headed; Loss of energy; This is a spontaneous report from a contactable ...
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Headache; Body aches; Light headed; Loss of energy; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old male patient reported for himself that he received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: Pfizer er8730, Expiration date: unknown) via an unspecified route of administration on 22Mar2021 at 13:00 on left arm at single dose for COVID-19 Immunization. Medical history included Chrones. The concomitant medication was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 23Mar2021 16:00 (24-hour clock), patient experienced headache, body aches, Lightheaded and Loss of energy. The patient did not receive any treatment for the events. The reporter assessed the event as non-serious. The events were not recovered. No follow-up attempts are possible. No further information is expected.
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| 54 | 2021-04-08 | electric shock sensation | Dizziness, "brain zaps", body aches, lethargy. |
| 54 | 2021-04-08 | flushing |
Pt. Noticed rash on antecubital area of both arms - worse on Left (vaccine side) then he felt flushe...
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Pt. Noticed rash on antecubital area of both arms - worse on Left (vaccine side) then he felt flushes, his face turned slightly pink. Code called. Paramedics arrived. Waited extra 15 mins & walked out with no issues.
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| 54 | 2021-04-08 | numbness, pain in extremity |
Pt is reporting of arm pain and after stating that symptom is common pt reported having some numbnes...
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Pt is reporting of arm pain and after stating that symptom is common pt reported having some numbness in leg. Informed patient to contact their healthcare provider for exam
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| 54 | 2021-04-09 | pain in extremity |
Within an hour started feeling weird. over the course of the next 36 hours, my reaction to the vacc...
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Within an hour started feeling weird. over the course of the next 36 hours, my reaction to the vaccine is awful. Worse than my covid. At least I know my body is doing what it is supposed to be doing. But it is just miserable. Massive headache, soreness, weird shooting pains in my leg, sweats and chills and nausea, and now the racing heart and shortness of breath.
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| 54 | 2021-04-13 | tingling |
Nausea, diarrhea, fatigue, tingling in hands and arms. Lasted 4-5 days. Caused to miss work. Conta...
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Nausea, diarrhea, fatigue, tingling in hands and arms. Lasted 4-5 days. Caused to miss work. Contacted PCP but did not go in for visit.
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| 54 | 2021-04-13 | tremor |
Roughly six (6) hours after I received my second dose I became extremely agitated and angered what I...
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Roughly six (6) hours after I received my second dose I became extremely agitated and angered what I would call a homicidal rage that lasted for about an hour which then morphed into a visual hallucinations those lasted for about an hour and those turned into racing heart with heart palpitations and bilateral involuntary hand movements tremors
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| 54 | 2021-04-14 | weakness | Fever of 102-105, headache, coughing, weaknesss |
| 54 | 2021-04-15 | inability to speak |
14 hours after vaccination patient experienced signs and symptoms of a stroke: aphasia, left arm wea...
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14 hours after vaccination patient experienced signs and symptoms of a stroke: aphasia, left arm weakness, clumsy, could not text. Called 911
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| 54 | 2021-04-15 | weakness, numbness |
Pt. stated "I started feeling numbness on my face and weakness 10 minutes after getting vaccinated."...
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Pt. stated "I started feeling numbness on my face and weakness 10 minutes after getting vaccinated." Vital signs taken BP 100/70, HR 76, O2Sat 99%, R 18. At 12:37pm pt. is still having numbness of face. EKG was done. Normal sinus rhythm. At 12:50pm pt. stated he wants to go to the hospital. At 12:52pm pt. was transported to healthcare facility.
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| 54 | 2021-04-15 | weakness |
first evening very painful shoulder -- at point of injectcion. next morning: ZERO mobillity in my s...
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first evening very painful shoulder -- at point of injectcion. next morning: ZERO mobillity in my shoulder and could not move left arm. now, six days later: shoulder is still hurting and mobility is limiited in my left arm to 40 degrees of movement. but painful. and very very weak. the injection seemed to be very high on my shoulder/muscle area compared to first shot. first shot had no or limited shoulder pain. this time, I am in quite a bit of shoulder pain and again, have very very liimited arm movement. it is like a partial tear of my rotator cuff, which I had in the other shoulder a few years ago. very weak shoulder, very limited abilitiy to move my arm.
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| 54 | 2021-04-15 | muscle spasms, tremor |
Chills, shake, fever, headache. Shaking stopped by 6 AM. Fever was low stopped by 8 AM. Took Advil o...
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Chills, shake, fever, headache. Shaking stopped by 6 AM. Fever was low stopped by 8 AM. Took Advil once. Constipation 48 hours. Cramps on day 2. Headache continues after 48 hours. Shortness of breath on day 2. Advil taken morning of day 2. Dizziness at times.
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| 54 | 2021-04-17 | bell's palsy |
Right Sided Bell's Palsy; This is a spontaneous report from a contactable Other-HCP reporting for a ...
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Right Sided Bell's Palsy; This is a spontaneous report from a contactable Other-HCP reporting for a patient. A 54-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Arm Right on 05Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included Stargardt's Disease, Prediabetes, Low Testosterone, Chronic neck pain, and covid-19. Concomitant medication included testosterone (AXIRON). No other vaccine received in four weeks. The patient experienced right sided bell's palsy on 07Apr2021 06:00. The event resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of right sided bell's palsy included Prednisone. Outcome of the event was not recovered. No Covid tested post vaccination. Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported Bell's palsy cannot be excluded based on a temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 54 | 2021-04-17 | feeling of body temperature change, pain in extremity |
This is a spontaneous report received from a contactable consumer (patient). A 54-year-old male pati...
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This is a spontaneous report received from a contactable consumer (patient). A 54-year-old male patient (height: 193cm, weight: 99.79kg) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EN6207) via an unspecified route of administration at right upper arm on 18Mar2021 18:00 (54-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history included blood pressure, teeth cleaned (Shortly before the shot, went to the dentist to have teeth cleaned. Directly from Dentist went to pharmacy. Went to pharmacy's Drive Thru to pick up a little antibiotic from the dentist. It was 4 capsules of Amoxicillin. He was supposed to take the Amoxicillin before the dentist office visit, but he forgot to do that. Therefore, soon as he left the dentist office he went to pharmacy to pick it up so he could take it. While he was there, was offered the COVID 19 vaccine and that it was the last shot). Concomitant medications included atenolol tablet from 2016 (been taking for 5 years) and ongoing for blood pressure, and ascorbic acid/ cyanocobalamin/ ergocalciferol/ nicotinamide/ pyridoxine hydrochloride/ retinol/ riboflavin/ thiamine mononitrate (ONE-A-DAY). No additional vaccines administered on same date. No history of all previously immunizations. No prior vaccincations wtihin 4 weeks. He got the shot Thursday and by Sunday, many different side effects were coming in. He has had side effects from the COVID VACCINE, but initially he does not want to file report, just thinks that everyone needs to get the shot. He does not have complaints. He is wondering how long the side effects will last, and when they go away. States that he is being treated as he has gone to the doctor's. Also states that he made an appointment with the doctor and almost went to the emergency room a couple of times. Right after the shot, he was getting in the car and his right leg started hurting (on 18Mar2021). It didn't go away for a couple of days. It went away but then noticed his shoes started feeling funny. He wasn't looking at his feet, put his shoes on they felt tight. Then he started to look at feet more. Below his knees, his legs are swollen. Swelling started within 2 to 3 days after the vaccine. The swelling is really severe when standing. Everybody at work has seen how sick he is and his legs. Swelling in the legs has him concerned, thinking maybe it's a blood clot. He was given medicine and would like to see it go away. He keeps his legs up. He has other side effects (all in Mar2021) and is having flu like symptoms. He basically has the flu. He has never had the flu shot. This is the first flu shot (He referred to the COVID vaccine as the flu shot as documented. However, confirmed suspect product as Pfizer covid vaccine) he has had that he knows of. He is questioning if he should get the second shot. He feels a little dizzy. Quick questions get him confused and that it comes and goes. Lungs felt full, gasping for air: not now but, since the doctor gave him antibiotics (unspecified injections, he was given 2 shots at the doctor's office, one in each arm), his lungs felt full. At times he was gasping for air. It went away but thought he was going to die. Now when he gets winded, it feels like he has a dry cough. Gets winded easily. The doctor ordered him an inhaler, Symbicort, but it was very expensive, so he did not get it at that time. He never picked it up because it was too much money. The fluid is not there anymore and he does not feel like he needs this as does not feel like it needs to be cleared. He is having wheezing. He can now take deeper breaths. Fatigue: initially, that he was feeling tired within 1 or 2 days, but he did not recall the next day feeling that way (later stated it was within 2-3 days he started to feel tired). He is still tired. Unable to clarify time frame of fatigue further. He feels bloated and full. Hasn't really eaten but feels real full and bloated. Hot and cold flashes started occurring about the same time as the other symptoms. He had these last evening. He does not get the flu very often and doesn't take the Flu shot. This is the closest thing he can remember having a pretty good episode with the flu. He was also given prescriptions for 2 new medications: Triamterene 37.5mg daily, for leg swelling; Clindamycin, 300mg, twice a day, an antibiotic. The odd thing is that it seems like his eyes are big, like really, really big, like they are really open. It is like big eye balls. States that he is just sick and his body is reacting to getting better. He has not been to work in the last 3 days. States that he is fine, just worried about work. Patient asked for personal advice about going back to work. The outcome of "his right leg started hurting" was recovered; outcome of "below his knees, his legs are swollen/ swelling in the legs/ put his shoes on they felt tight" and Fatigue/feeling tired was not recovered; outcome of other events was unknown.
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| 54 | 2021-04-17 | numbness |
Numbness in feet beginning 23 hours after 2nd vaccination. Toes white in color similar to what reyna...
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Numbness in feet beginning 23 hours after 2nd vaccination. Toes white in color similar to what reynauds syndrome looks like. Massaging to see if that helps, but it's been about an hour with no change. Heart rate and forehead temp normal. No other significant symptoms.
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| 54 | 2021-04-17 | pain in extremity | Muscular and joint pain in the knees, hands, and lower back. |
| 54 | 2021-04-18 | night sweats, numbness and pain in extremities |
chills, night sweats, chest pain, body aches, nausea, anorexia, back pain now, 16 lb weight loss, co...
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chills, night sweats, chest pain, body aches, nausea, anorexia, back pain now, 16 lb weight loss, cough when sitting up and moving, peripheral neuropathy, - chest pain resolved but other issues are persistently bad, adv some of the initial symptoms could have been related to the shot, such as initial body aches and chills, but persistent and worsening issues are NOT expected this far out. I adv HCF eval given likely unrelated persistent symptoms, consider ED if effects are severe and worsening. He will likely go in tonight but he isn't sure where he will go. I adv try not to drive yourself call back if issues. PCC will FU tomorrow with patient at home. 4/11-Patient positive for Covid per MD at hospital Follow up call - Patient feeling better today, went to ED at hospital , was prescribed Flexeril, Ibuprofen and ondestron. Second vaccination is next week.
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| 54 | 2021-04-18 | night sweats |
Persistent Increased heart 110-114bpm started 8-10 hours after the injection and continued roughly 3...
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Persistent Increased heart 110-114bpm started 8-10 hours after the injection and continued roughly 30-36 hours. My heart rate while sleeping was over 95+ bpm and 110-114bpm while awake In addition, I had severe joint aches, fatigue, night sweats, fever for 48-72 hours.
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| 54 | 2021-04-18 | pain in extremity |
About a week after my first shot i experienced the start of a rash on my lower back.Did not think mu...
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About a week after my first shot i experienced the start of a rash on my lower back.Did not think much of it at the time,assumed contact dermatitis. Rash started to spread slowly,used hydrocortosone daily as needed.Contacted my PCP on 4/09 virtually and he told me to keep an eye on it.After my 2nd shot I experienced the usual fatigue and arm.pain but my rash got worse.,Contacted local urgent care provider on 4/18/2021 @11:25 AM.My provider was Doctor. By this time my rash was all over my back and had travelled to my front.After full mock up she diagnosed me with a pityriays-rosea condition .She prescribed me kenalog 0.1% predisone cream and Benadryl for itching.
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| 54 | 2021-04-20 | burning sensation, discomfort, tingling, tenderness |
The pain that is felt is like many needle punctures on primarily the right lung, but has been felt o...
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The pain that is felt is like many needle punctures on primarily the right lung, but has been felt on the left lung at times. The pain is not constant but rather at random times throughout the day. This sudden, sharp, needle-like pain was felt mostly on the following dates: Tuesday, 04/13/2021 (both lungs felt pain twice early in the morning around 1:00 AM and a few more times in the afternoon), Sunday, 04/18/2021 (pain felt twice only on right lung around 2:00 PM), Monday, 04/19/2021 (pain felt on right lung around 10:00 AM and again around 4:00 PM), and on Tuesday, 04/20/2021 (pain felt on right lung around 1:30 PM). Since Monday, 04/19/2021, a constant feeling of discomfort, tenderness, and slight burning has been felt on the right lung.
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| 54 | 2021-04-20 | burning sensation |
Patient presented to the vaccination observation area at 11:35. At 11:50 patient stated his tongue w...
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Patient presented to the vaccination observation area at 11:35. At 11:50 patient stated his tongue was numbness and whole body feeling burning and itches. No rash noted on the skin. He requested Diphenhydramine, he refused the Epi-pen and PO 50mg Diphenhydramine was administered. Site Lead came over speak with patient. Site Lead spent 20 minutes educating and encouraging patient to take Epi-pen and the need to call 911 ambulance due to his symptoms. Pt refused the Epi pen and calling 911 and stated that his condition is not getting worse. VS is BP 170/100, P 62, RR 20, O2 99% Pt stated that his BP 170/100 is his baseline on BP medications. Pt agreed to stay in observation for longer. At 12:50pm, pt stated that his tongue numbness is getting better only the back of tongue feeling numbness and the whole body feeling burning resolved, only the hands and back of ankles are itches. VS has not changed BP 170/100, O2 98%, RR 22, P 61. At 1:15pm, pt stated that hands itches resolved, back ankles itches are still itches. Only R side of back of the tongue still numbness.L side tongue numbness resolved. VS BP 170/100, RR 22, O2 100%, P 61. At 1:30pm, pt stated that L side back ankle itches resolved, only R side of back ankle still a little itches. R side tongue still numbness but less than 15min. VS BP 170/100, RR 20, P 61, O2 98%. At 1:30pm, pt left observation area. Advised pt to take public transportation to go back to work or home instead of self drive due to pt had Diphenhydramine 50mg, pt stated that he will consider the options of public transportation. Pt instructed s/sx when to reach out to PCP or ED.
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| 54 | 2021-04-20 | sensory loss |
Suspected Guillain Barre Syndrome. With bowel incontinence, urinary retention, motor and sensory we...
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Suspected Guillain Barre Syndrome. With bowel incontinence, urinary retention, motor and sensory weakness. Seems to all be involving S1-S5 nerves only. Had some mild foot drop on 3/25/2021 but then developed severe symptoms starting 4/15/2021 with rapid progression leading to hospitalization on 4/17
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| 54 | 2021-04-21 | pain in extremity | Joint swelling in hands three days after shot. Joint swelling and pain in big toe of right foot. |
| 54 | 2021-04-21 | tingling |
11:39 am stated he was feeling sleepy , Vital sign were done 11:50 patient stated that his tongue f...
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11:39 am stated he was feeling sleepy , Vital sign were done 11:50 patient stated that his tongue felt different , experiencing nausea , clear emesis , Per Dr order , I gave patient benadryl 25 mg po. patient was alert . patient was left for further evaluation . 12:45 pm the patient began to complain about tightness off and on , nausea , emesis continue , whole body felt tingly. 12:47pm per Dr order , i administer the Epi Pen was administer . 911 was called . paramedics was transport to hospital .
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| 54 | 2021-04-23 | pain in extremity |
Flu-like symptoms, fever of 99.6, chills, nausea, headache, arm pain, for about 24 hours. Took Tyle...
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Flu-like symptoms, fever of 99.6, chills, nausea, headache, arm pain, for about 24 hours. Took Tylenol and Ibuprofen cold and sinus
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| 54 | 2021-04-23 | tingling, pain in extremity |
My arm in not longer sore from the injection , However I continue to have a tingling from the inject...
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My arm in not longer sore from the injection , However I continue to have a tingling from the injection spot down my left arm into my fingers . It feels like a nerve problem in my arm. It has been over a month and the problem has not gone away
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| 54 | 2021-04-26 | pain in extremity |
Pain in arm - no longer occurring 3 days after pain in left side of testicle, pain is getting worse...
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Pain in arm - no longer occurring 3 days after pain in left side of testicle, pain is getting worse - still occurring Per poison specialist - Unknown if it is due to vaccine or not because it is not a usual/listed side-effect of the vaccine. Needs to get checked by PCP to run tests such as an ultrasound to check for any abnormalities and rule that out.
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| 54 | 2021-04-26 | cold extremities, pain in extremity, migraine, numbness |
soreness in arm and elbow within 30 minutes, soreness and sharp pain on the whole upper body after 2...
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soreness in arm and elbow within 30 minutes, soreness and sharp pain on the whole upper body after 2hrs. severe pain in all joints and never seen before crippling arthritis within 4 days. numbness in my hands, severe neck, back, elbow and wrist joint pain. sores and infections all over my legs after 5 days. migraines. blood pressure and severe glucose spikes without substantial change in diet. now no feeling in hands other than ice-cold fingers that never warm and constant pain.
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| 54 | 2021-04-27 | burning sensation, tingling |
I have symptoms of paresthesia. first dose was very mild (only pricking sensations for a few hours t...
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I have symptoms of paresthesia. first dose was very mild (only pricking sensations for a few hours the first day and limited to my extremities). Second dose the symptoms are pricking and burning sensations that are more intense and are quite frequent. They also happen almost everywhere on my body and are random in nature. Pfizer 2nd dose is lot # ER8729 given to me on April 15.
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| 54 | 2021-04-27 | muscle spasms |
continuous spasming across middle back to left kidney area, groin area, random spasming in abdomen a...
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continuous spasming across middle back to left kidney area, groin area, random spasming in abdomen area, lower chest; no treatment as of yet
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| 54 | 2021-04-27 | unresponsive to stimuli |
Patient received the vaccine then reported to the observation area. After a few minutes in the obser...
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Patient received the vaccine then reported to the observation area. After a few minutes in the observation area the patient stated he was light headed and dizzy and might pass out. A few moments later the patient passed out. He passed out from his chair to the floor where he was assessed by pharmacists and a nurse. He was sweating and was coming in and out of responsiveness. Patient never stopped breathing. 911 was called and patient was taken away by EMS. Patient was still in and out of responsiveness when EMS arrived.
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| 54 | 2021-04-28 | discomfort |
I started feeling drugged about 2 hours after the shot. I then experienced extreme fatigue and felt ...
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I started feeling drugged about 2 hours after the shot. I then experienced extreme fatigue and felt unwell / sick for 6 days. My joints were extremely sore in my back, ankles and wrists. My body felt heavy and it was hard to stand and walk. It felt as if I was losing circulation in my feet. By 5PM each day I was in bed passing out for about 2 hours each day. Most of each day on couch sick. On day 5, I broke out in hives on my face. All symptoms began to clear on day 7. I was almost feeling normal Apr 28. Today, Apr 29 I feel OK.
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| 54 | 2021-04-28 | tingling |
Visual Snow Syndrome. Event started around 10pm last night. Lasted until 2:00am this morning. Also h...
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Visual Snow Syndrome. Event started around 10pm last night. Lasted until 2:00am this morning. Also had other symptoms such as "visual trailing" associated with Visual Snow Syndrome. I had previously reported Paresthesia as another side effect of Pfizer.
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| 54 | 2021-05-03 | pain in extremity |
Leukocytes in urine; urinating blood; Dark colored urine; couldn't sleep; anxiety; sweat; arm pain; ...
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Leukocytes in urine; urinating blood; Dark colored urine; couldn't sleep; anxiety; sweat; arm pain; lightheaded; Abdominal Discomfort; prostate infections; This is a spontaneous report from a contactable consumer reporting for himself. A 54-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 24Mar2021 at 14:30 (at the age of 54 years old) as a single dose in the right arm for COVID-19 IMMUNIZATION. Relevant medical history included benign prostatic hyperplasia (BPH) and cholesterol. The patient was diagnosed with BPH a few years back 2016 or 2017 and had a uralist in 2019 and that resolved his issues. The patient had been on no BPH meds and back to normal since that procedure. Co-suspect medication included atorvastatin (LIPITOR) from an unknown date to 01Apr2021 at 40 mg, 1x/day for blood cholesterol. On an unspecified date in Mar2021, the patient experienced prostate infections, and abdominal discomfort. On 25Mar2021, the patient experienced arm pain, and was lightheaded. He described the arm pain as he had deltoid pain but he also had pain like he had been hit from his right pectoral down his arm to about 4-5 inches above his wrist. On 31Mar2021, the patient experienced couldn't sleep, anxiety, sweat, urinating blood, and dark colored urine. The patient was concerned with the dark urine so he stopped taking atorvastatin, and called his physician who said he didn't need it anyhow. The patient visited the urologist office and was prescribed ciprofloxacin (CIPRO) as treatment for dark colored urine, urinating blood and prostate infection. On 06Apr2021, the patient experienced leukocytes in urine. Relevant lab data on 06Apr2021 included a urinalysis which resulted in leukocytes and blood +3. The action taken in response to the event dark urine with atorvastatin was permanently withdrawn. The outcome of the events prostate infection, and abdominal discomfort was recovered on an unspecified date in 2021. The outcome of the events arm pain, and lightheaded was recovered in 26Mar2021. The outcome of the events couldn't sleep, anxiety, and sweat was recovered on 01Apr2021. The outcome of the events urinating blood and dark colored urine was recovered on 06Apr2021. The outcome of the event leukocytes in urine was unknown.; Sender's Comments: Based on the current available information, the serious events Prostate infection, Blood in urine, and Urine color abnormal are most likely related to an intercurrent or underlying condition which is not related to the suspected drugs. Relevant medical history of benign prostatic hyperplasia (BPH) may provide a plausible explanation for the events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021450744 same patient/SD, different AE/dose
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| 54 | 2021-05-04 | numbness, weakness |
24 Hours after 2nd vaccination came down with fever of 103, shaking chills, and weakness all over. S...
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24 Hours after 2nd vaccination came down with fever of 103, shaking chills, and weakness all over. Slept 6 hours and symptoms subsided. 2 days after started having severe numbness in hands and feet. a few days later started having weakness in arms and legs, progressed over next week to the point I was unable to walk. Began steroid infusions on Mon 26 Apr. Admitted to hospital Wed 28 May for assessment and treatment. Released home on 30 Apr and returned 1 May for outpatient steroid.
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| 54 | 2021-05-09 | paralysis, weakness |
Weak when woke up. Fell 2 times was then paralyzed on that Sunday A. M. went to ER was Dx with GBS ....
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Weak when woke up. Fell 2 times was then paralyzed on that Sunday A. M. went to ER was Dx with GBS . Guillan Barre Syndrome. Hospitalized. Now in rehab hospital
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| 54 | 2021-05-14 | seizure |
convulsions; Fever (up to 103 F degrees); chills; confusion; dizziness for first 48 hours; body ache...
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convulsions; Fever (up to 103 F degrees); chills; confusion; dizziness for first 48 hours; body aches for 96 hours.; This is a spontaneous report from a non-contactable consumer who reported for himself. A 54-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0172), via an unspecified route of administration, in Arm Left on 20Apr2021 at 13:30 (at 54 years) at single dose for covid-19 immunisation . Medical history included known allergies penicillin. Previously, on 29Mar2021, patient took the first dose of the vaccine (lot Number: EQ0150) administered in Arm Left for covid-19 immunisation. The patient's concomitant medications were not reported. Patient had no COVID prior vaccination and was not covid tested post vaccination. On an unspecified date in 2021 patient experienced fever (up to 103 F degrees), chills, convulsions, confusion, dizziness for first 48 hours, body aches for 96 hours. No treatment given. Patient recovered from all the events on an unknown date in 2021. No follow-up attempts are possible. No further information is expected.
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| 54 | 2021-05-16 | numbness |
pt states his head felt like it was 10 x the normal size. There was a lot of pressure on the left si...
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pt states his head felt like it was 10 x the normal size. There was a lot of pressure on the left side of the head and ear. The left side of his was face numb and he lost all hearing in left ear. He went to ER on 4/22/21. They removed ear wax and was prescribed amoxicillin and Mucinex. His symptoms did not improve so went to his PCP, on 4/29/21( he had to see his assistant ). They prescribed prednisone 40mg. He was referred to ENT. He saw her on 5/3/21. He was then prescribed 60mg prednisone and was given a hearing test. He had lost 20% of hearing at that point. He went back to ENT on 5/10/21 and had another hearing test. His hearing was better and almost back to normal but says he continues to have ringing in his head. He has a MRI scheduled on 5/24/21 further treatment.
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| 54 | 2021-05-19 | weakness, slurring |
Date 04/30/2021 Onset of symptom at approximately 1:30pm: developed slurred speech. Lost of strengt...
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Date 04/30/2021 Onset of symptom at approximately 1:30pm: developed slurred speech. Lost of strength started to left lower extremity and weakness and followed up to left upper extremity with lost of strength and weakness. Symptoms lasted approximately 3 minutes, and was taken to Hospital with an admitting diagnosis of Transit Ischemic Attack.
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| 54 | 2021-05-19 | cold sweat |
After the 15 minute post shot waiting period patient said he felt "confused" with clammy hands. H...
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After the 15 minute post shot waiting period patient said he felt "confused" with clammy hands. He sat in the chair and was slow to talk. I asked him if he was diabetic, and he responded that he was, but he never feels this way and had eaten before coming in. After talking a while longer, I was going to ask him if he'd like us to check his sugar, he asked me if we had a blood pressure cuff. I said we did, but he wanted to use the machine in front of the store because he felt well enough to get up and wanted to walk. I walked to the machine with him. He sat and answered the many questions tapping on screen with no issues at all. The confusion was not evident. The maching reported 111/68 or very close, with a pulse of 48. He said, "that's the issue, my pulse is down. I need to walk around." I said he could stay back at the pharmacy where we could see him, or we could call someone for him. He said staying back here would not help his pulse. I told him there was no hurry, he'd been here for his 15 minutes, but we could keep an eye on him or help him and call whatever he needed. He said no, he'd be fine, he just needed to walk around. He now had pressure in his head, not really a headache just pressure, he said it was all related to his pulse. He said if he needed help later he could always go to an Urgent Care, I offered again to call anywhere for him or call for assistance, he was not interested.
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| 54 | 2021-05-19 | flushing, weakness |
Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / ...
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Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Weakness-Mild, Additional Details: 5 minutes following second dose of pfizer pt with syncopal episode. LOC for 10 seconds, came to spontaneously without intervention. Pt placed in trendelenburg, regained consciousness. vital signs stable, blood sugar stable, no injury.
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| 54 | 2021-05-19 | pain in extremity |
Extremely Sore Left arm for 22 days. No treatments. Constipation for 6 days. Enema given. Light Feve...
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Extremely Sore Left arm for 22 days. No treatments. Constipation for 6 days. Enema given. Light Fever on days 3,4, and 6. No treatments. Severe coughing with lung pain from day 7- Present. Treatment is cough drops/Dextromethorphan HBr on Day 26. No male penis erections from Day 10-30. No treatments. Extreme Nausea from Day 14-Present. Feelings of vomiting but never did. 4-6 hours each day.
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| 54 | 2021-05-22 | slurring | Fever to T max 105.3, tachycardia to HR 135, altered mental status (lethargic, nonsensical speech) |
| 54 | 2021-05-25 | weakness, discomfort |
ED Discharged 5/5/2021 - 5/6/2021 (3 hours) Last attending ? Treatment team Acute nonintractable h...
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ED Discharged 5/5/2021 - 5/6/2021 (3 hours) Last attending ? Treatment team Acute nonintractable headache, unspecified headache type Clinical impression Headache Chief complaint Triage Note: To ED c/o severe HA behind R ear since being dx w COVID 4/30. Denies cough, dyspnea, fevers. Reporting he has had 1 round of COVID vaccines. Has taken "alieve, tylenol, and advil" w/o relief. Last doses all "early this morning." pt awake and alert in triage. History of Present Illness Patient is a 54 y.o. yo male presenting to the ED with severe headache behind the right ear since 4/30. Patient was diagnosed with Covid at that time and has taken 1 round of the Covid vaccine. He has tried Aleve, Tylenol and Advil without relief. He states that his last dose were all early this morning. Denies any numbness or tingling, visual disturbances, ataxia, photophobia. He has no history of strokes, MI or blood clots. He states that prior to his Covid diagnosis he is otherwise healthy. ED Discharged 5/8/2021 (4 hours) Last attending ? Treatment team COVID-19 Clinical impression Fever Chief complaint Medical Decision Making 54-year-old male who presents today due to uncontrolled fever, diagnosed with Covid on April 30. Symptomatic for about 2 weeks now. On exam appears to be uncomfortable, is febrile and tachycardic, however remaining vitals are stable. Physical exam is also reassuring. Patient not complaining of any chest pain, shortness of breath, lightheadedness. Will provide patient with symptomatic relief including fluids and ibuprofen, if able to improve patient's symptomatology will have him discharged home. His labs also show some slight hyponatremia, he will likely improve from fluids as I believe this is secondary to his diarrhea that he has been having over the last few days. CK also slightly elevated, would likely benefit from fluids. After a single liter of fluids, patient symptoms improved, fever and tachycardia also improved, continues to endorse some generalized weakness, will give second liter of fluid and Tylenol at this time as he is due for this. After receiving a second liter, the patient states that his symptoms have greatly improved at this time, comfortable returning home. I advised the patient that she should take ibuprofen and Tylenol on 6-hour cycles very regularly, he can take it in a pattern where he takes Tylenol followed by ibuprofen 3 hours later followed by Tylenol again 3 hours later, as long as he keeps 6 hours in between doses, explained to him that he should not take this any sooner than this however he should be sure to take these regularly as these will help control his fever. Also encouraged him to hydrate appropriately as this will likely prevent him from feeling poorly. He is agreeable with this plan, I provided him with appropriate return precautions.
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| 54 | 2021-05-26 | flushing |
Patient reported feeling "flushed" in the face, lightheadedness, and shortness of breath during 15 m...
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Patient reported feeling "flushed" in the face, lightheadedness, and shortness of breath during 15 minute post-vaccination observation period. States this felt like when he received contrast for imagining which resolved without intervention. Patient was given diphenhydramine 25 mg oral suspension. Patient reported that symptom were improving by time of discharge. MD discussed with patient that additional dose of diphenhydramine could be administered if symptoms persisted. Patient felt well enough to go home. Wife accompanied the patient.
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| 54 | 2021-05-26 | pain in extremity |
Extreme tired; Chills; Arm pain; This is a spontaneous report from a contactable consumer (patient) ...
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Extreme tired; Chills; Arm pain; This is a spontaneous report from a contactable consumer (patient) . A 54-year-old male patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN5318) via an unspecified route of administration in left arm on 01Feb2021 at 07:30 (at 54 years) at single dose for covid-19 immunisation. Medical history included kidney donor.No known allergy. There were no concomitant medications. On 01Feb2021 at 10:00 the patient was extreme tired and experienced chills and arm pain.No treatment given and patient recovered from the events in Feb2021.No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021201495 same patient, different drug/AE
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| 54 | 2021-05-27 | hot flush, feeling hot, tingling |
Client received the 2nd COVID vaccine (Pfizer Lot # EW0185 and 06/19/2021) at 1906. At 1917 client w...
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Client received the 2nd COVID vaccine (Pfizer Lot # EW0185 and 06/19/2021) at 1906. At 1917 client was sitting in the observation area when he suddenly ran to one of the trash cans and started throwing up. PHN and EMT responded and assisted client into a chair and gave him an emesis bag. The client threw up one more time into the bag. Client stated that he ?suddenly felt nauseas, almost feels like a nervous reaction.? Client stated, ?I felt chills down my spine that traveled into my arms and my fingers tingled and my ears got hot. It felt like a hotflash.? Client was alert and oriented times four, and his skin was warm, and color was appropriate to race. Vital signs were taken at 1919 (blood pressure 110/78, heart rate 76, oxygen 96%). Client stated at 1921 ?I?m feeling better now,? and that the nausea had subsided. Vital signs were taken at 1924 (blood pressure 122/72, heart rate 73, oxygen 94%). Client was offered Benadryl by PHN and client refused. Client stated that he was feeling worried about receiving his second dose of the vaccine, ?we know someone who got their second dose a couple weeks ago and was paralyzed from it.? Client also stated that he was working outside in the sun all day. Vital signs taken at 1934 (blood pressure 122/80, heart rate 75, oxygen 96%). Client offered juice by PHN and he accepted and drank it. Client does not have any medical conditions, is not on any medications, and does not have any allergies. PHN advised client to follow up with his primary care provider, and education was provided to client on life threatening symptoms and to seek emergency services if he developed any. At 1947 client stated, ?I?m feeling fine,? and he left the facility unassisted with a steady gait.
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| 54 | 2021-05-27 | seizure | SEIZURE MEMORY LOSS IN COHERENT |
| 54 | 2021-06-01 | pain in extremity |
2 weeks after the first dose Awful pain and stiffness in both hands. went to DR on 4/12 did blood w...
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2 weeks after the first dose Awful pain and stiffness in both hands. went to DR on 4/12 did blood work diagnosed with RA. Did not think about the vaccine until two weeks after the second dose I struggle to walk with severe pain in my legs, arms, and hands. Life since has been pretty rough passed out from the pain on May 16th had to have 9 staples in my head. Now my life is trying to balance medication so I can sleep at night. And get through the days at work. I have had to miss days.
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| 54 | 2021-06-01 | unresponsive to stimuli |
Patient went swimming at a fitness center the day after he had his 2nd COVID-19 vaccine and was foun...
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Patient went swimming at a fitness center the day after he had his 2nd COVID-19 vaccine and was found unresponsive at the bottom of the shallow 4.5 deep pool while exercising. He was not able to be revived. The death certificate says that the immediate cause of death was Arrhythmia resulting from Hypertensive Atherosclerotic Cardiovascular Disease.
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| 54 | 2021-06-02 | sensory loss |
Feeling unwell, General body aches; he does every once in a while get an asthma episode; Fever; Feel...
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Feeling unwell, General body aches; he does every once in a while get an asthma episode; Fever; Feel a bit achy; Mild headache; vision is hard to focus; Not feeling right on and off; This is a spontaneous report from a contactable consumer or other non hcp (Patient himself). A 54-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection, Batch/Lot Number: EW0150, expiry date: unknown), via an unspecified route of administration, administered in right arm on 02Apr2021 as 1st dose, single for covid-19 immunization. The patient's medical history included Type 2 Diabetes mellitus, patient reported that it was diagnosed at least 10 years ago, and his sugar levels had been in very good control, Covid-19 from unknown date in Nov2020 to unknown date in Dec2020. The patient's concomitant medications were not reported. On 03 Apr 2021maybe started Saturday after the vaccination the patient experienced with mild Headache and not feeling right on and off for 6 days. Patient reported that his head feels worse since he got the slight fever, he took Tylenol to deal with the fever in morning, like 11:00 AM then he did not feel quite right, probably feels worse to next day, sometimes his vision was Hard to focus he was to struggle a bit to focus or just worse because of the fever. since he got the vaccine, in the first couple days, he might have just felt like things were a little blurry and again it was very mild, but it seems worse than it had. on 08Apr2021 the patient feels little achy, and he took the Tylenol and only felt worse because of the fever and later felt better and had general body aches the patient did have COVID back in the end of November, then he recovered in the beginning of December, he got an asthma episode still that he believes was triggered by the COVID. The patient reported that he had a blood work on 03 MAR 2021, he saw his doctor on 10 MAR 2021 and his blood work was pretty normal. His blood sugar was very good, and he also has been very active, he walks every day. The patient enquired second dose was scheduled for 23 APR 2021, was it fine to have a second dose. The patient did not visit Emergency Room or No Physician Office. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. Patient took TYLENOL 500 mg for the treatment to the events (LOT: SJA014, scan code:30044439; NDC: 50580-449-36EXP: 06/2024). The outcome of the events headache, vision is hard to focus was not recovered, fever was recovering, feeling unwell, general body aches, feel a bit achy asthma episode and was unknown. No follow-up attempts are needed. No further information is expected.
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| 54 | 2021-06-02 | speech disorder |
Approximately 24 hours after second Pfizer vaccine dose, patient reported having severe vision and b...
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Approximately 24 hours after second Pfizer vaccine dose, patient reported having severe vision and balance problems, headache and severe fatigue and memory loss. Vision symptoms included hallucinations, tunnel vision and blurred. Unable to stand up without staggering. Confusion. Difficulty verbalizing thoughts. Treated with ivermectin, D3, Z, quercitin, aspirin and other supplements on advice of doctor. Symptoms persisted in severe form for 48 hours, then began to improve. At 6/3/2021, blurred vision while reading, higher than normal heart rate during exercise, fatigue and intermittent memory loss. Being treated by doctor and kinesiologist for brain injury from vaccine
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| 54 | 2021-06-03 | pain in extremity |
Right arm sore; Slight headache; This is a spontaneous report from a contactable consumer, the patie...
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Right arm sore; Slight headache; This is a spontaneous report from a contactable consumer, the patient. A 54-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6201) via an unspecified route of administration in the right arm on 16Mar2021 at 08:30 (at the age 54-years-old) as a single dose for COVID-19 immunisation. Medical history included high cholesterol from an unknown date. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not have any allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included simvastatin (ZOCOR) from an unknown date. On 17Mar2021, 22 hours post vaccination the patient experienced sore in right arm and had slight headache. The patient did not receive any treatment for the events. The clinical outcome of events sore in arm and headache were resolving at the time of reporting. No follow-up attempts are needed. No further information is expected.
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| 54 | 2021-06-07 | weakness |
Temperature ranging up to 102.6; body ache; headache; extreme weakness; cough; sleepiness; This is a...
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Temperature ranging up to 102.6; body ache; headache; extreme weakness; cough; sleepiness; This is a spontaneous report from a contactable consumer (patient). A 54-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for Injection, Lot Number: EN6198) via an unspecified route of administration in arm left on 05Mar2021 at 15:15 (at the age of 54-year-old) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for Injection, Lot Number: EM9809) via an unspecified route of administration in arm left on 12Feb2021 (at the age of 54-year-old) at 1ST DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had no known allergies. Patient did not have covid prior vaccination. Patient has not tested covid post vaccination. On 06Mar2021, the patient experienced Temperature ranging up to 102.6, body ache, headache, extreme weakness, cough, sleepiness. Patient did not receive treatment for the adverse events. The patient underwent lab tests and procedures which included body temperature: 102.6 on 06Mar2021. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.
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| 54 | 2021-06-07 | muscle spasms | Severe muscle cramping - upper back, neck, trapezoid |
| 54 | 2021-06-09 | nerve pain |
Patient had mild symptoms after the second dose, classic fever, body aches, etc. which resolved afte...
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Patient had mild symptoms after the second dose, classic fever, body aches, etc. which resolved after 1-2 days. Then 1 week later, he had more fevers and chills with worsening body aches, particularly right leg pain and worsening headaches and nausea. Rash developed on right lower extremity in an S1 dermatomal distribution, with severe neuropathic pain associated. PCR panel revealed Varicella Zoster Virus. Patient also presented with meningitis symptoms including headache, nuchal rigidity, and photophobia. PE positive for Kernig and Brudzinski signs.
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| 54 | 2021-06-09 | tingling, pain in extremity, numbness |
3 days after receiving the 2nd Pfizer shot, the pt began experiencing numbness in both feet and toe...
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3 days after receiving the 2nd Pfizer shot, the pt began experiencing numbness in both feet and toes as well as R hand. A week later R thigh tingling followed by bilateral leg pain. Spread to calf region then knee caps toward the end of May. Then, balance became difficult, feeling like he was falling to the right. Was admitted to medicine service. Over course of week continued to decline and no longer can walk, needs bed lift to use the bathroom. Currently on day 1 of 5-day IVIG treatment. Due to possible tick exposure has also been receiving Abx for Lyme.
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| 54 | 2021-06-10 | bell's palsy |
I had Bells Palsey a few years ago and the symptoms came back very minor but hasn't gotten any bette...
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I had Bells Palsey a few years ago and the symptoms came back very minor but hasn't gotten any better. Not complete paralysis on my fight side of face but reduced strength by more than 50%; This is a spontaneous report from a contactable consumer (patient). A 54-year-old male consumer received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration in right arm on 08Apr2021 at 14:15 as single dose for COVID-19 immunization. Medical history of the patient included Bell's palsy (a few years ago) and known allergies (nine patient is aware of). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication received within 2 weeks of vaccination included cetirizine hydrochloride (ZYRTEC) for an unspecified indication. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in right arm on 25Mar2021 at 14:15 as single dose for COVID-19 immunization. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 09Apr2021 at 05:00, 14 hours 45 min after receiving second dose of vaccination, the symptoms of Bell's palsy came back very minor but had not gotten any better, not complete paralysis on patient's right side of face but reduced strength by more than 50 per cent. Outcome of the event was not resolved. Information on the lot/batch number has been requested.
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| 55 | 2021-01-05 | pain in extremity |
top of left hand red; top of left hand pain; uncomfortable to open left hand; left wrist swollen; le...
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top of left hand red; top of left hand pain; uncomfortable to open left hand; left wrist swollen; left hand swollen/the top of his left hand was warm and red; regular shot pain in left shoulder; regular shot pain in left shoulder/ top left wrist pain; This is a spontaneous report from a contactable consumer(patient). A 55-year-old male patient received the first dose of BNT162B2 (lot number: EH9899), via an unspecified route of administration in left arm, on 22Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were none. The patient stated that he got his Pfizer Covid vaccination on Tuesday last week on 22Dec2020. The patient had few days regular shot pain in left shoulder. The patient stated that on Thursday(24Dec2020) that he was okay but got on his wrist on same arm and top of hand swollen was painful to movement. The patient stated that the top of his left hand was warm and red on Saturday(26Dec2020). The patient experienced top of left hand pain and top left wrist pain on 26Dec2020. The patient stated that he got the Covid vaccination in his left arm. The patient stated that on Sunday that he made a clinic appointment and they sent him anti-inflammatories. The patient stated that now he was getting better. The patient was uncomfortable to open left hand 25Dec2020. The patient stated that the pain in his left shoulder resolved Thursday or Friday. The patient stated that he can see his hand muscles more defined now. The patient stated that he can stretch his left hand better than before. The patient stated that he had blood work in doctor in Oct2020. The outcome of the events"regular shot pain in left shoulder" was recovered, of the event"top of left hand red" was not recovered and of the other events was recovering.
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| 55 | 2021-01-06 | pain in extremity |
Arthralgia right arm soreness; numbness & tingling upper lip 12/29 12:15 received the vaccine. 12/30...
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Arthralgia right arm soreness; numbness & tingling upper lip 12/29 12:15 received the vaccine. 12/30 0600 woke up with a sore arm and joint aches. 12/31 woke up with numbness and tingling across her enter upper lip. It is constantly present. Her sore arm and joint aches have improved. She denies all other symptoms. 12/31 later in the day her lip tingling resolved as did her sore arm and joint aches.
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| 55 | 2021-01-08 | cold sweat | Sweaty/Clammy, vomiting Narrative: |
| 55 | 2021-01-10 | numbness |
A few days after first shot, noticed numbness in left little toe which progressed to 3,4,5 digits. A...
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A few days after first shot, noticed numbness in left little toe which progressed to 3,4,5 digits. After second dose (1-2days later) numbness extended to both feet, all digits, soles, and outside foot
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| 55 | 2021-01-11 | feeling hot |
Severe left knee pain and stiffness without trauma. No redness or swelling. Feeling of heat on ant...
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Severe left knee pain and stiffness without trauma. No redness or swelling. Feeling of heat on anterior of both lower extremities. Associated with chills and moderate fatigue.
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| 55 | 2021-01-12 | feeling cold | Total body malaise, headache, chills |
| 55 | 2021-01-12 | pain in extremity |
Pain in right leg since evening of injection. Got rash 1 week after injection on right buttock . Fou...
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Pain in right leg since evening of injection. Got rash 1 week after injection on right buttock . Found to have shingles when saw pmd today
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| 55 | 2021-01-14 | numbness |
numbness to left little toe; This is a spontaneous report from a contactable physician. A 55-year-o...
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numbness to left little toe; This is a spontaneous report from a contactable physician. A 55-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration, at the left arm on arm on 17Dec2020 10:15 at single dose for COVID-19 immunization at a hospital. Medical history included prostatitis. No known drug allergy. Concomitant medication included clindamycin hcl. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 21Dec2020 08:00, a few days after first shot patient noticed numbness to left little toe. This progressed slowly to 3rd and 4th digit. After second shot (day 2), patient noticed this now extended to both feet, digits 3-5, sole of feet, and outside edge of feet. No pain just numbness. The patient was not tested for it since the vaccination. The patient took the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), on 07Jan2021 at the left arn for COVID-19 immunization. The patient did not received any treatment for the event. The patient has not recovered from the event.
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| 55 | 2021-01-14 | night sweats | mass in left brachial lymph nodes 11cmX8cmX5cm i also have fever chills and night sweats body aches |
| 55 | 2021-01-15 | pain in extremity | fatigue arm pain, metallic taste, jaw pain, abdominal cramping, loose stool |
| 55 | 2021-01-17 | night sweats |
severe body aches; severe chills; night sweats; Fatigue; This is a spontaneous report from a contact...
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severe body aches; severe chills; night sweats; Fatigue; This is a spontaneous report from a contactable Physician (patient). A 55-year-old male patient received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Jan2021 at 12:00 at single dose in left arm for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose bnt162b2 in Dec2020 three weeks ago at 12:00 noon in the left arm for covid-19 immunization and experienced mild pain at the injection site which lasted two days and then was gone. The patient experienced severe body aches, severe chills, night sweats, and fatigue on 07Jan2021. Event details: The patient reported that he received the first dose of the Pfizer COVID 19 vaccine three weeks ago at 12:00 noon in the left arm. He did not know the exact date. After the first dose there was mild pain at the injection site which lasted two days and then was gone. He received the second dose of the Pfizer COVID 19 vaccine on 06Jan2021 at 12:00 noon in the left arm. He noticed 12 hours later severe body aches, severe chills, and night sweats. He also felt fatigue. Everything had mostly resolved except for the night sweats and they were still pretty severe. All events were reported as serious by reporter per medically significant. The outcome of event night sweats was not resolved, outcome of other events was resolved on 10Jan2021. Information about lot/batch number has been requested.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported severe body aches, severe chills, fatigue and night sweats, and the administration of the COVID 19 vaccine, bnt162b2, based on the reasonable temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
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| 55 | 2021-01-17 | pain in extremity | Slight fever. Severe left arm pain with arm pit swollen gland. |
| 55 | 2021-01-21 | pain in extremity |
had vaccine 12/30. About 1/1 had ill feeling, very tired, soreness in joints, extreme pain in arm/ ...
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had vaccine 12/30. About 1/1 had ill feeling, very tired, soreness in joints, extreme pain in arm/ legs. did not have breathing problem. pain and limited range motion lasted until 1/7/21. I called health clinic and they told me to call cdc number on vaccination card. That number sent me to reporting center, no help. Called family physician, they said they knew nothing about vaccine. Since i wasn?t having breathing problem i just dealt with pain and took Tylenlol couple times each day. Took second dose vaccine 1/20/21.
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| 55 | 2021-01-22 | numbness |
12 hours after injection: 12 hours after injection and then resolved the next day: drenching night s...
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12 hours after injection: 12 hours after injection and then resolved the next day: drenching night sweats severe joint pain especially in hips and knees - even ribs hurt passed out and disoriented significant contracture of bilateral upper extremities from elbow to hands when I could not open them for over an hour rt ear tinnitus numbness in hands and feet tiredness
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| 55 | 2021-01-24 | pain in extremity |
On January 21,2021 developed headache and on January 22,2021, left arm pain, warm to touch, redness...
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On January 21,2021 developed headache and on January 22,2021, left arm pain, warm to touch, redness and contralateral hand swelling (right )
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| 55 | 2021-01-26 | weakness |
First episode 01-15-21, started 10am, i was at work, started feeling weak and brain fog so i sat dow...
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First episode 01-15-21, started 10am, i was at work, started feeling weak and brain fog so i sat down and another therapist came into the office and told her how i was feeling, they checked my BP 148/92, went to the ER. They took some blood work, CBC panel were negative, thyroid test, normal, anaiongap, normal, glucose reading, normal and an EKG normal. 2nd episode 01-21-2021 started 11;45am, that morning when i woke up i felt really strong feelings of sadness and despair. At 11;45a i was about to eat and i started to feel again brain fog, total body weakness, elevated BP, they took my BP again and it was 144/88 so i went to the ER again. I could not keep my eyes open. They did a EKG again with a CTA and a CT with perfusion both were normal. They gave me fluids, sodium fluids. Agian it was transient my BP slowly went down and went home. Third episode 01-25-2021 started about 9am, i was at home did not have access to a BP cup, symptoms were same but less intense, i could feel my heart pounding, brain fog and body aches and this lingered throughout the day. It felt like I had the flu. No elevated temperature on all three of my episodes.
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| 55 | 2021-01-26 | weakness |
It started abruptly, i experienced brain frog and super weak, globally with al muscles and was very ...
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It started abruptly, i experienced brain frog and super weak, globally with al muscles and was very fatigues and malaise. I had access to a blood pressure cup the reading was 148/92, usually my BP is 100/60. Once they took my BP, then i went to the ER. As time went on, I got more sleepy and tired. The first ER visit they did lab work, CBC panel which was normal, thyroid test which was normal, EKG and aniongap which were negative. They gave me no medications to take and was probably there in the ER for about 6 hours. which was on 01-15-2021. The second time, it was around 11:45am on 01-21-2021. While sitting at the edge of my bed, I felt a total sadness and despair and feeling of being alone. I then went to work felt normal in the morning and as i went to type some notes after a minute i felt the same symptoms happening again, my BP 140/88 and went to the ER. I was really tired and could of fallen asleep, felt oriented but took me a while to process things. I also had trouble moving my entire body. They placed an IV, gave me fluids, did an EKG again which was normal. They did a CT scan, CTA to my chest and neck and CT perfusion, had to inject contrast, exams were both normal. The doctor came in and told me if I was okay to drive home and I drove home. On the third episode. 01-25-2021 it occurred around 9am, the symptoms came back but with less intense. I lied down and rested., could feel my heart racing just like the other two episodes. This symptom lasted for about two hours and kind of lingered all day but i could still function. i felt like I had the flu, moderate malaise with brain fog.
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| 55 | 2021-01-28 | pain in extremity |
Within 16 hours, fever of 102, extreme fatigue, significant headache, body aches throughout, sore ar...
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Within 16 hours, fever of 102, extreme fatigue, significant headache, body aches throughout, sore arm, chills, lymph nodes under arm receiving vaccine swollen, temperature of 100.5 48 hours later.
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| 55 | 2021-02-01 | tingling |
patient complained of feeling "tingly and off". At 1610, BP 173/109, pulse 50, 100% on room air, E...
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patient complained of feeling "tingly and off". At 1610, BP 173/109, pulse 50, 100% on room air, EKG in the field WNL. Denied headache and chest pain. Rested for 30 min. BP 183/105 at 1637. Patient reported feeling normal and agreed to follow up with primary MD or go to ER if symptoms worsened.
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| 55 | 2021-02-08 | pain in extremity, weakness |
99.7 low grade fever, extreme body aches including aches and pains in feet which made it painful to ...
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99.7 low grade fever, extreme body aches including aches and pains in feet which made it painful to walk, hand ached which made it hard to make a fist, all joints hurts especially hips and low back. Extremely low on energy causing me to have to sleep longer during the night and nap twice the next day.
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| 55 | 2021-02-09 | weakness |
2/2/2021- seen in Ed with c/o intermittent fever following 2nd dose. Redness to bilateral upper ext...
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2/2/2021- seen in Ed with c/o intermittent fever following 2nd dose. Redness to bilateral upper extremities, c/o some pain with urination, weak. V/S stable, afebrile in ED. Assess for infection. No significant abnormal labs (see below), hydrated and discharged. 2/4/2021- arrived in ED with c/o vomiting, seen earlier by PCP that day labs drawn. Shortly after arriving in the ED copious amouts of emesis noted, the patient went into full cardiac arrest and CPR was started. -Please see HPI above, in addition after intubation the patient coded again. More epinephrine and lidocaine were given. CPR was resumed. We did obtain ROSC and targeted temperature management was pursued. He is placed on a lidocaine drip and a right femoral central line was placed by myself. At this time, norepinephrine drip was initiated given his continued hypotension. Post intubation chest x-ray suggests possible abdominal pathology and once the patient was stabilized further, he was sent to the CT scanner where CT head without IV contrast and CT chest, abdomen and pelvis with IV contrast was obtained. He did lose pulses once in the radiology suite. This was brief. IV fluids were initiated and he received over 2 L of crystalloid therapy. He continued to be hypotensive in the emergency department and vasopressin was added. He also had a single dose of Neo-Synephrine and IV push fashion to help bring his blood pressure up. CT scan reveals probable bilateral aspiration pneumonia/pneumonitis and dilated loops of small bowel without a transition point and pneumatosis involving loops in the left upper quadrant. I did try to initiate consult with critical care and possible transfer, however he continued to be unstable and coded requiring CPR multiple times. He was given IV bicarbonate given his prolonged CPR state and pH. Ultimately, the family decided to make the patient comfort measures only given his critical illness. Shortly after making this decision he did pass away in the emergency department. RADIOLOGY DIAGNOSTIC - CHEST PORTABLE 02/04 2051 *** Report Impression - Status: SIGNED Entered: 02/04/2021 2059 IMPRESSION: 1. Findings highly suspicious for portal venous gas which can be seen in the setting of bowel ischemia. Consider CT for further evaluation and/or surgical consultation. 2. Endotracheal tube 3.7 cm above the carina. 3. Low lung volumes with mild patchy perihilar opacities. Final Report Signed by: M.D., Sign Date/Time: 02/04/2021 8:55 PM Impression By: MD CT SCAN - CT HEAD WO 02/04 2140 *** Report Impression - Status: SIGNED Entered: 02/04/2021 2200 IMPRESSION: Negative for acute intracranial process. No evidence of mass effect, acute hemorrhage or definite acute cortical infarct. Final Report Signed by: M.D., Sign Date/Time: 02/04/2021 9:57 PM Impression By: - MD CT SCAN - CT CHEST/ABD/PELVIS W 02/04 2140 *** Report Impression - Status: SIGNED Entered: 02/04/2021 2214 IMPRESSION: 1. Ill-defined patchy opacities within the bilateral upper lobes, right middle lobe, in consolidative opacities within bilateral lower lobes which could represent aspiration, and/or multifocal pneumonia. 2. Small right trace left pleural effusions. 3. Diffusely dilated small bowel without a transition point and mucosal hyperenhancement involving the colon with areas of pneumatosis involving loops of small bowel within the left upper quadrant and portal venous air consistent with hypoperfusion complex. There is a small caliber appearance of the aorta and a flattened appearance of the IVC is well. 4. Intravascular air within the IVC and bilateral iliac veins could be secondary to right femoral central lying injection. 5. Somewhat abnormal enhancement pattern of the kidneys with hypoenhancement of the medullary pyramids which may suggest hypoperfusion injury as well. 6. Probable nondisplaced rib fractures on the right at ribs 2 through
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| 55 | 2021-02-09 | grand mal seizure | gran mal seizure |
| 55 | 2021-02-10 | weakness |
This was my 2nd shot. (1st shot was 3 weeks prior). Four days after 2nd shot, I developed wheezi...
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This was my 2nd shot. (1st shot was 3 weeks prior). Four days after 2nd shot, I developed wheezing and congestion. On my 6th day, I had an asthma attack. I obtain an albuterol inhaler and used it occasionally for the next 3 days. Today, after 11 days, I still have a slight cough but feel like I'm getting my energy back.
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| 55 | 2021-02-11 | numbness |
Patient complained of burning sensation and achiness from left deltoid up to left side of neck and b...
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Patient complained of burning sensation and achiness from left deltoid up to left side of neck and behind left ear. Patient complained of left ear clogged, numbness, swelling, with swelling and tingling of lips. Patient took ibuprofen. Went UC and ED, was prescribed prednisolone.
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| 55 | 2021-02-12 | pain in extremity |
SORE LEFT ARM ON 2ND DOSE, FATIGUE, ITCHY LEFT & RIGHT ARMS AND HANDS, ITCHING NECK AND UPPER BACK. ...
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SORE LEFT ARM ON 2ND DOSE, FATIGUE, ITCHY LEFT & RIGHT ARMS AND HANDS, ITCHING NECK AND UPPER BACK. TOOK BENADRYL AND RESOLVED
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| 55 | 2021-02-13 | numbness |
Patient at appointed time for second dose and related this event. Patient reported that the vaccine ...
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Patient at appointed time for second dose and related this event. Patient reported that the vaccine site became progressively painful, swollen and bruised starting the day after the vaccination. The swelling progressed including his hand, numbness in the ulnar nerve area. By 3-4 days after vaccination he was unable to lift his shoulder so he saw his PCP who suspected a hematoma or thrombus but found neither. He then saw an orthopedist Feb 3 or 4 who was uncertain but sent him to Physical Therapy with a diagnosis of axillary nerve injury. See continuation page
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| 55 | 2021-02-17 | night sweats, pain in extremity |
sore arm; terrible chills; night sweats; This is a spontaneous report from a contactable consumer, t...
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sore arm; terrible chills; night sweats; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 22Jan2021 at 12:15 (at the age of 55 years-old) in the left arm as a single dose for COVID-19 immunisation. Medical history included Behcet's disease and penicillin allergy; from unknown dates and unknown if ongoing. Prior to the vaccination, the patient was diagnosed with COVID-19 from an unknown date and unknown if ongoing. Concomitant medications included adalimumab (HUMIRA), testosterone (MANUFACTURER UNKNOWN), citalopram hydrobromide (CELEXA), dexlansoprazole (DEXILANT), and paracetamol (TYLENOL); all taken for unknown indications from unknown dates and unknown if ongoing. It was unknown whether the patient received any other vaccine within 4 weeks prior to the vaccine. The patient previously took sumatriptan (IMITREX) from an unknown date to an unknown date and experienced allergy. On 23Jan2021, the patient experienced sore arm, terrible chills, and night sweats. The patient did not receive any treatment for the events. The clinical outcomes sore arm, terrible chills, and night sweats was recovering. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 55 | 2021-02-18 | slurring | vision skewed, balance off, speech slurred, syncope, |
| 55 | 2021-02-18 | slurring | syncope, headache, slurred speech 2 days |
| 55 | 2021-02-19 | flushing | high blood pressure: 188/110; patient felt flushed , unwell and experienced vertigo |
| 55 | 2021-02-21 | weakness |
Patient was tested for covid on 2/2/21 with positive resulted. Presented to Hospital ER on 2/10/21 w...
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Patient was tested for covid on 2/2/21 with positive resulted. Presented to Hospital ER on 2/10/21 with c/o of abdominal pain. Diagnosed with gastritis, prescribed metoclopromide and famotidine and dc home. Returned to ER on 2/13/21 with c/o of weakness, diarrhea, foot ulcer, and loss of appetite. Diagnosed: 1) Dyspnea and hypoxia secondary to Covid-19 2) Extensive bilateral lung infiltrates secondary to Covid-19 3) Increased Cr 4) Increased LFTs, ferritin, d-dimer, troponin secondary to Covid-19 5) Elevated procalcitonin placing the patient at high risk for sepsis 6) Chronic appearing Right foot wound without signs of secondary infection Patient transferred to a different hospital in another city.
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| 55 | 2021-02-22 | seizure |
Per H&P and physician notes, patient was admitted to hospital on 2/7/21 with status epilepticus from...
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Per H&P and physician notes, patient was admitted to hospital on 2/7/21 with status epilepticus from home. He had received his second dose of COVID19 vaccine on 2/6/21 per Emergency Department note. Patient was febrile on admission (40.7 Celsius) and was intubated. Patient had issues with hypotension, neurologic impairment, and metabolic issues. Received pressors, IV fluids, Keppra, IV antibiotics to cover for possible CNS infection. Lumbar puncture performed. Abnormal EEG on 2/9/21. Recurrent seizure on 2/10/21. Pt extubated on 2/12/21. Blood cultures, urine culture, and CSF culture all no growth. Sputum culture mixed oral flora. As of 2/22/2021, patient tolerating tube feeds, shakes head yes and no responding to questions.
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| 55 | 2021-02-28 | pain in extremity |
Patient had the first dose of the Pfizer COVID vaccine (LOT# EL9264) on 1/29/21 at the vaccination ...
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Patient had the first dose of the Pfizer COVID vaccine (LOT# EL9264) on 1/29/21 at the vaccination center at Medical Center (set up in Hotel). He had the second dose on 2/19/21 (LOT# EN6201) at 12:30pm, and reported leg pain and difficulty breathing on 2/26/21 as he was going to bed. He presented to the ER at Hospital that day, and was diagnosed with a deep venous thrombosis and pulmonary embolism. He is currently taking Xarelto, and will schedule an appointment with Hematology, as he has no family or personal history of clotting disorder.
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| 55 | 2021-02-28 | cold extremities |
2 fingers on m left hand are cold to the touch. Taking a touchless thermometer reading the temperatu...
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2 fingers on m left hand are cold to the touch. Taking a touchless thermometer reading the temperature read 78°. There is no pain but the fingers are cold.
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| 55 | 2021-03-03 | muscle spasms, tenderness |
Within two hours Swelling on the left arm - upper part and it was painful. The first dose of the vac...
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Within two hours Swelling on the left arm - upper part and it was painful. The first dose of the vaccine, the pain started the second day and the injection site got swollen. But this second dose was within 2 hours of my vaccine even more and overwhelming fatigue. - aches, chills, muscle cramps, coughing, sweating - those lasted three days; headache - ever present and felt like head was in a vice; breathing was an issue - asthma was triggered on Sunday - I started prednisone - informal dr consultation with a friend - on Tuesday because of the asthma and by Friday I was feeling halfway better again and by the following Sunday about 75% better. 9 days later I was back at work. It took that week back at work though to get back out of the funk and by the following weekend I was close to 90%. Pain in the shoulder lasted about two weeks - it was quite tender for that long.
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| 55 | 2021-03-04 | pain in extremity |
pain in right arm redness swelling; pain in right arm redness swelling; pain in right arm redness sw...
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pain in right arm redness swelling; pain in right arm redness swelling; pain in right arm redness swelling; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL9261), via an unspecified route of administration in the right arm, on 22Jan2021 at 17:00 (at the age of 55-years-old) at a single dose for COVID-19 immunization. The patient had no medical history or allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications, taken within two weeks of vaccination, included atorvastatin calcium (LIPITOR). The patient experienced pain in right arm redness swelling on 23Jan2021. The events were reported as non-serious. The patient did not receive any treatment for the events. The clinical outcome of pain in right arm redness swelling was recovered on an unspecified date. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 55 | 2021-03-06 | pain in extremity |
I received my 2nd vaccine shot on Tues. 03-02-2021 and it has my right side from my neck down going ...
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I received my 2nd vaccine shot on Tues. 03-02-2021 and it has my right side from my neck down going into my fingers in severe pain, 6 days after receiving my 2nd dose. I have been taking Tylenol 500mg for pain and its not helping at all.
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| 55 | 2021-03-07 | tremor, cold sweat |
Extreme fatigue, loopiness, slight vomiting in first two days but not since, shaking hands (happened...
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Extreme fatigue, loopiness, slight vomiting in first two days but not since, shaking hands (happened on two days, was worse in the mornings but improved as day went on), cold sweats.
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| 55 | 2021-03-08 | pain in extremity |
Dizziness starting 20 minutes after vaccination. Slightly fast heartrate, sweating, anxiousness star...
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Dizziness starting 20 minutes after vaccination. Slightly fast heartrate, sweating, anxiousness starting within 1 hour of vaccination. All of the aforementioned symptoms went away by approximately 5.5 hours after vaccination. Left arm sore starting several hours after vaccination, increasing during the 24 hours after vaccine, then went away by roughly 48 hours after vaccination.
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| 55 | 2021-03-10 | flushing | Facial flushing, lightheaded-Cleared by EMS |
| 55 | 2021-03-10 | night sweats |
Soreness in shoulder yesterday. The next day had headache and tiredness and fever with chills. Last ...
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Soreness in shoulder yesterday. The next day had headache and tiredness and fever with chills. Last night had sweats the whole night. Felt fine this morning, all symptoms had gone. Feels pretty good today.
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| 55 | 2021-03-13 | weakness |
injection site pain, minor, 36 hours duration, resolved no treatment tiredness, 10 hours duration, r...
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injection site pain, minor, 36 hours duration, resolved no treatment tiredness, 10 hours duration, resolved - sleep swollen lymph nodes, start within 30 minutes, duration 8 hours, resolved no treatment throat swelling, start within 1 hour, duration 6-8 hours, resolved no treatment dizziness and weakness, start within 2 hours, duration 6 hours, resolved - sleep
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| 55 | 2021-03-13 | unresponsive to stimuli, tremor, weakness |
Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: A...
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Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Shakiness-Medium, Systemic: Weakness-Severe, Additional Details: note: pt stated no allergies on form and when asked verbally by immunizer. at the 7 minute mark he began to exhibit weakness and started falling off his chair. seemed like he was going to pass out. his breathing seemed labored. we position pt on floor, rph admin epipen to left outer thigh. 911 called. ems responded. pt felt better after epipen. bp, hr normal. pt taken to er by ems
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| 55 | 2021-03-14 | electric shock sensation |
STARTING AROUND 12:00pPM I EXPERIANCED TWO TIMES WHERE MY HEART STARTED TO RACE FOR ROUGHLY 5 SECOND...
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STARTING AROUND 12:00pPM I EXPERIANCED TWO TIMES WHERE MY HEART STARTED TO RACE FOR ROUGHLY 5 SECONDS. AFTERWARDS I EXPERIANCED SHOCK LIKE SENSATIONS AROUND CHEST, AND BACK. NOT SURE IF RELATED TO THE INJECTION BUT NEVER HAD PRIOR AND DIDN'T HAVE THE DAY AFTER OF SINCE
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| 55 | 2021-03-14 | pain in extremity |
ongoing left arm pain. No neck symptoms. Pain radiates to forearm. No numbness. No weakness. Last a...
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ongoing left arm pain. No neck symptoms. Pain radiates to forearm. No numbness. No weakness. Last advil was last night.
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| 55 | 2021-03-14 | pain in extremity | 'Fuzzy brain' & forgetfulness lasting 24 hours. Sore arm lasting 48 hours |
| 55 | 2021-03-18 | bell's palsy |
Bell's palsy; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male...
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Bell's palsy; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 at the age of 55-year-old, via an unspecified route of administration, administered in left arm on 16Feb2021 08:30 (Lot Number: EN6200) as single dose for COVID-19 immunisation. There were no medical history and concomitant medications. On 20Feb2021, the patient started developing some tingling and the right side of his face doesn't work anymore. The next day (21Feb2021) he went to the doctor and he was diagnosed with Bell's Palsy. He has got full blown, right side of his face was flop, bell's palsy. He went to the doctor and they put him on Prednisone, which he was still treating. The event required a visit to the physician office. The outcome of the event was unknown.
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| 55 | 2021-03-19 | weakness, discomfort, electric shock sensation |
30 minutes after receiving vaccine, felt like electric shocks in the head (two to three times). It s...
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30 minutes after receiving vaccine, felt like electric shocks in the head (two to three times). It stopped in the evening but got constant low headaches afterwards. Around 5pm, felt like a change in taste (saltier taste) that was temporary. Has uncomfortable wrist pain like twisting a screwdriver too much. Started feeling itchy today after 9 am. Face was swollen after waking up today and has subsided greatly since. Had very low fever last night and now feels like no fever. Right now, feeling has a lot of saliva and then have to swallow and little uncomfortable in arms and knees, and weakness. Only took one Aleve pill last night. Around 4:30pm, felt a little blurry for 5 to 10 seconds.
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| 55 | 2021-03-19 | weakness |
I started having severe diarrhea the day after the shot , i am weak and exhausted, ight headed , its...
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I started having severe diarrhea the day after the shot , i am weak and exhausted, ight headed , its been going on now 6 days
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| 55 | 2021-03-20 | tingling |
syncopal episode, elevated HR, tingling in fingers, daughter states he's "afraid of needles," EMS ev...
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syncopal episode, elevated HR, tingling in fingers, daughter states he's "afraid of needles," EMS evaluated, patient refused transport.
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| 55 | 2021-03-22 | feeling hot |
Approximately 10 minutes after 1st dose of Pfizer vaccination. Pt. was fanning himself, appeared dia...
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Approximately 10 minutes after 1st dose of Pfizer vaccination. Pt. was fanning himself, appeared diaphoretic with mask down. He flagged down nurse and reported feeling hot/lightheaded. NP asked for BP machine, instructed patient to take slow deep breaths. Pt. reported he felt like he may lose consciousness. His eyes rolled and he became white/pale and appeared to stop breathing. Code assist called; didn't respond to sternal rub, but raspy breathing, weak/rapid pulse palpated; immediately transferred to the ground level without falling, 2 person assist. 9-1-1 called, BP machine didn't immediately work. As soon as his head was low, his face became bright red and he regained consciousness. He was disoriented briefly but then able to answer questions/oriented. BP elevated, HR 80s. BS 257. No s/s anaphylaxis. Hx of syncope r/t blood draw. Wife present and report hx of DM, HTN, Palpitations. He denied CP/SOB or palpitations. He had eaten and took regular medicine the morning. Paramedic arrived and patient was transported to the nearest ER. Pt. was later discharged.
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| 55 | 2021-03-23 | facial pain | Face very sore and facial glands very swollen. ( hard to eat/ chew) Some lower back pain. |
| 55 | 2021-03-23 | flushing, feeling hot |
Patient was vaccinated on 3/1/2021 with 1st dose Pfizer, lot EN6205 expiration date 6/30/2021. Patie...
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Patient was vaccinated on 3/1/2021 with 1st dose Pfizer, lot EN6205 expiration date 6/30/2021. Patient informed RN that he had flushing, felt hot and dizzy approximately 2min after receiving 1st dose and symptoms resolved 2min afterwards. Patient denied allergies, medications, and medical conditions. Patient suffers from seasonal allergies. RN relayed information to PHN who texted the medical team. Per the medical team, patient is to wait until 28 days post 1st Pfizer dose before receiving Janssen vaccine, it is not recommended to receive Pfizer 2nd dose. Patient was advised to consult with his provider. VAERS report submitted 3/24/2021, confirmation number
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| 55 | 2021-03-23 | pain in extremity, numbness |
24 hours post-vaccination, patient developed SEVERE arm pain, such that he has been unable to sleep ...
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24 hours post-vaccination, patient developed SEVERE arm pain, such that he has been unable to sleep thru the night and is in near constant pain. Now 6d post vaccination and still very severe pain. Otherwise healthy and fit 55yo. Only able to hold his arm in a couple of positions to get relief from the pain. Feeling numb in entire lower left arm.
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| 55 | 2021-03-24 | weakness, tingling |
Diarrhea , weakness, sharp pain on back left flank, needles in pelvis and extremities, cold extremit...
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Diarrhea , weakness, sharp pain on back left flank, needles in pelvis and extremities, cold extremities, headache, disoriented
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| 55 | 2021-03-24 | weakness |
Within 5-minutes of vaccination, the patient reported weakness and confusion. EMS evaluated the pati...
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Within 5-minutes of vaccination, the patient reported weakness and confusion. EMS evaluated the patient on-site. No signs of stroke. EKG demonstrated NSR, rate 77bpm, no ST elevation. FSBG was 290mg/dl. EMS transported the patient to Hospital Emergency Department. Enroute, the patient became increasingly confused, forgetting their birthday and location. Patient was hypertensive (178/104) and reported a "crushing headache". EMS crew became concerned for stroke. In ED, the patient remained hypertensive (178/93). ED Physician had high suspicion of TIA versus acute reaction to COVID-19 vaccine. Administerd 650mg acetaminophen and 1mg Lorazepam. Admitted patient to critical care unit where patient stated they had developed a sudden-onset diffuse banding-like headache with associated nausea, diaphoresis, blurry vision, and confusion. MRI was negative and patient was transferred from ICU to hospital. Hospital physician believed the symptoms were likely a vagal mediated response or reaction to his COVID vaccination. Patient was discharged on 3/20 with diagnoses of TIA, Acute encephalopathy, Insulin-dependent type 2 diabetes, Essential hypertension, CAD, Unspecified mood disorder, Dyslipidemia, Obesity, and Mild neuro cognitive disorder
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| 55 | 2021-03-24 | pain in extremity | Painful lump in my arm pit that came on the morning of 3/25/21. |
| 55 | 2021-03-24 | paralysis, nerve pain, sensory loss |
Extreme exacerbation of CIDP symptoms. Weakness and paralysis of extremities, inability to walk, lo...
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Extreme exacerbation of CIDP symptoms. Weakness and paralysis of extremities, inability to walk, loss of sensation in hands and feet, marked increase in neuropathic pain
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| 55 | 2021-03-25 | muscle spasms |
fatigue, flu-like symptoms, cramping in the legs and neck, severe back pain. Slept 18 hours a day ...
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fatigue, flu-like symptoms, cramping in the legs and neck, severe back pain. Slept 18 hours a day for three days
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| 55 | 2021-03-27 | numbness | Numb face, forehead and right ear. Ringing in the ears |
| 55 | 2021-03-27 | pain in extremity, numbness and pain in extremities |
Intense pain around base of tailbone. Mild fever, fatigue, hand/wrist pain, sensitivity to cold. ...
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Intense pain around base of tailbone. Mild fever, fatigue, hand/wrist pain, sensitivity to cold. Intense bloating.
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| 55 | 2021-03-28 | weakness |
Experienced all symptoms that occured for my actual covid disease. These include dizziness, aches i...
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Experienced all symptoms that occured for my actual covid disease. These include dizziness, aches in joints and muscles, extreme chills, injection site soreness(4-5 days), headache, complete lack of appetite and overall weakness. All symptoms lasted for approximately 36 hours.
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| 55 | 2021-03-28 | weakness |
Symptoms started 3/19/21 and was diagnosed with COVID-19 on 3/21/21. Presented to ED with weakness, ...
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Symptoms started 3/19/21 and was diagnosed with COVID-19 on 3/21/21. Presented to ED with weakness, cough, confusion and fever on 3/27/21. He was started on supplemental oxygen, remdesivir, and dexamethasone and was admitted to hospital for 3 days.
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| 55 | 2021-03-28 | feeling hot |
started to lose his vision; he couldn't see anything; Shot was painful; he started to get hot with t...
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started to lose his vision; he couldn't see anything; Shot was painful; he started to get hot with the sweats; he started to get hot with the sweats; terrible headache; dizziness; nauseated; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 12Mar2021 00:30 (lot number: ENG6199) (at age 55 years old) as single dose for covid-19 immunization administered in a pharmacy or drug store. The patient had no relevant medical history. No known allergies. The patient had no covid prior to vaccination and was not tested post vaccination. Concomitant medication included tramadol taken for numbing shot for tooth, start and stop date were not reported. No other vaccines received in four weeks. The patient experienced the following with his first dose of the Pfizer vaccine. Shot was painful and in about 15 to 20 minutes later everything felt fine. But by the time he and his wife drove out of town, he started to get HOT with the sweats, terrible headache, dizziness and started to lose his vision. He pulled over to let his wife drive and by the time he got out of the car he could barely navigate to the passenger side. They turned around and headed for the hospital, 8 min away, at this time he couldn't see anything, he was nauseated but knew the hospital was pretty close. During this whole time his heart rate never raced just kept and even beat. His breathing was also just fine. By the time they got into the parking lot his vision was slowly getting better, so they sat in the parking lot for 30 minutes with the air conditioner on as high as it could go. His wife read through the side effects, he was experiencing many on the list. They left without going in. Onset of the events was reported as 12Mar2021 12:45 AM. Treatment was not given for the events. The patient recovered from the event "shot was painful" on 12Mar2021; while recovered from the rest of the events on an unspecified date in Mar2021.
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| 55 | 2021-03-28 | numbness, bell's palsy |
3 days after dose 3/23, felt pain in back of head behind right ear. 3/25, felt right side of face sl...
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3 days after dose 3/23, felt pain in back of head behind right ear. 3/25, felt right side of face slightly numb. 3/27, visited ER , CT Scan taken. Diagnosed with Bell's Palsy.
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| 55 | 2021-03-28 | tingling | tingling foot, gout |
| 55 | 2021-03-29 | flushing |
Arm started to swell around 3 PM. I had to quit work and go home. I was experiencing some moderate t...
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Arm started to swell around 3 PM. I had to quit work and go home. I was experiencing some moderate to severe pain in my left arm where the injection occurred. It is almost 9 PM and the arm still hurts, but not like before. On a scale of 1 to 10 the pain factor was about 5 to 7. I was experiencing some mild shock symptoms (flush face). I couldn't use my left arm for anything, the pain was too great.
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| 55 | 2021-03-30 | weakness |
Within hours, severe conjunctivitis, muscle pains, back pains, knees swelling. One knee required s...
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Within hours, severe conjunctivitis, muscle pains, back pains, knees swelling. One knee required swelling. Debilitation and difficult to walk. I've visited 5 different doctors in 3 weeks. Some symptoms subsided but then they returned following the second shot 3 weeks later.
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| 55 | 2021-03-30 | pain in extremity |
Right arm pain next morning; Unable to lift arm above shoulder height without sharp pain; This is a ...
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Right arm pain next morning; Unable to lift arm above shoulder height without sharp pain; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration, in the right arm on 03Feb2021 03:45 PM (at the age of 55-years-old) as single dose for COVID-19 immunisation. The patient had no medical history. The patient no allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date for COVID-19 immunisation. It was reported that the patient expereinced right arm pain next morning on 04Feb2021. Unable to lift arm above shoulder height without sharp pain on 04Feb2021. No treatment was given to the events. Outcome of the events were recovered on 05Feb2021. Information about batch/lot number has been requested.
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| 55 | 2021-03-31 | night sweats |
I was woken up at about 1:15AM with major night sweats and vividly scary dreams of scary faces . I ...
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I was woken up at about 1:15AM with major night sweats and vividly scary dreams of scary faces . I opened my eyes and I was still seeing the scary faces that were scaring me and causing me to yell and move around in bed while asleep. I girlfriend said I was yelling and moving around a lot prior to waking up. Once awake, I was still seeing the visions for about 2 minutes until I turned on the light and my eyes adjusted to the brightness. When I turned the light off and tried to go back to sleep, the faces appeared again. I was not able to go back to sleep and ended up getting out of bed and going out on the couch to watch TV to avoid being in the darkness and closing my eyes. I'm not one to dream very often and this was certainly and vividly scary night.
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| 55 | 2021-04-02 | feeling of body temperature change, weakness |
The second day I only had a sore arm where I received the injection. Thereafter, and up until 4/2/21...
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The second day I only had a sore arm where I received the injection. Thereafter, and up until 4/2/21 PM when going to bed I had fluctuations of hot and cold sweats, difficulty sleeping, daily low grade fever, neck and shoulder pain, mild to medium headaches, and a much lower than usual energy levels.
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| 55 | 2021-04-02 | pain in extremity |
Extreme Fatigue; Achiness all over body, particularly back of arms; pain in joints, particularly an...
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Extreme Fatigue; Achiness all over body, particularly back of arms; pain in joints, particularly ankle joints, soreness in arm (expected this) and 102.9 temp
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| 55 | 2021-04-03 | weakness, pain in extremity |
No issues at/during injection, didn't even feel needle surprisingly. 1st 24 hrs, arm soreness as ty...
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No issues at/during injection, didn't even feel needle surprisingly. 1st 24 hrs, arm soreness as typical vax reaction 4 me. But that 2nd day after, G.I. issues began middle of nite. So fatigued & short-of-breath, barely made it to dialysis, where they put me on oxygen. All during treatment, BP fluctuated 90-170, temp 96-101, chills (shivering!), continued fatigue & weakness, even after leaving - they wanted to give me antibiotics & send me to e.r.!!! Staff did collect blood sample for culture (result in 24 hrs + neg). I refused antibiotics and e.r., convinced it was vax reaction, and I was right, all normal another day later. Anxious bout 2nd shot ??
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| 55 | 2021-04-03 | weakness |
On the night after my vaccination in bed I was very dizzy. Next morning dizzy and weak, and now when...
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On the night after my vaccination in bed I was very dizzy. Next morning dizzy and weak, and now whenever I put my head back I get dizzy and still when I go to bed dizzy when I?m laying down and when I move on my side. The dizziness does not stop. I?m also experiencing shortness of breath as a result from my daily walks, this never happened before.
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| 55 | 2021-04-04 | pain in extremity | right foot pain starting less than 24 hours later |
| 55 | 2021-04-04 | pain in extremity |
4-5-21 11AM: PT STATES 'PAIN RT ARM (DESCRIBES DELTOID) WHEN HE PUTS HIS ARM ABOVE HIS HEAD.', SINCE...
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4-5-21 11AM: PT STATES 'PAIN RT ARM (DESCRIBES DELTOID) WHEN HE PUTS HIS ARM ABOVE HIS HEAD.', SINCE 3-28-21. DENIES ANY PAIN TO SHOULDER OR ELBOW. HAS NOT USED HEAT, COOL PACK OR ANY PAIN MED TO RELIEVE PAIN. HAS NOT SEEN PCP. NO CHANGE IN PAIN SINCE ONSET.
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| 55 | 2021-04-04 | pain in extremity | Right foot pain worsening |
| 55 | 2021-04-04 | tingling |
Client reported feeling "dizzy, nauseous, and tingly" in the observation area approx 5 mins. after r...
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Client reported feeling "dizzy, nauseous, and tingly" in the observation area approx 5 mins. after receiving 1st Pfizer dose. Client was led to wheelchair by EMT and placed in front of the area for closer observation. V/S taken at 2:30pm: HR 58, RR 22, BP 110/68, AOx3. V/S taken at 2:35pm: HR 66, RR 18, AOx3 BP 120/76 and client statement "feeling much better." At 2:45pm client walked away unassisted. No medication or treatment given.
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| 55 | 2021-04-04 | tremor | chills and shakes followed by sweats. |
| 55 | 2021-04-05 | feeling cold |
Lots of pain at injection area. Severe chills lasting 3 hours, sharp pain in right hip. Afterward,...
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Lots of pain at injection area. Severe chills lasting 3 hours, sharp pain in right hip. Afterward, real tired and a little lethargic.
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| 55 | 2021-04-05 | pain in extremity |
Pain in upper arm and neck for close to a week. Got shot on Wednesday and felt sore throughout body...
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Pain in upper arm and neck for close to a week. Got shot on Wednesday and felt sore throughout body especially around upper arm and neck. By Friday had biting pain around neck. Could barely move it on Saturday and Sunday. Monday the biting pain left and neck pain started to let up. Tuesday seems like pain is getting better.
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| 55 | 2021-04-06 | feeling cold, weakness |
On 1/16/2021 I stated having ringing in my ears. I had chills, pain on the vaccine site, dizziness, ...
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On 1/16/2021 I stated having ringing in my ears. I had chills, pain on the vaccine site, dizziness, & weakness. I seen my doctor and they did a hearing test he diagnosed with tinnitus. Other symptoms were gone in 2-3 days except tinnitus that is getting worst.
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| 55 | 2021-04-06 | seizure |
Patient received 2nd dose of Pfizer at 10:14 am on left deltoid, lot # ER8729, expiration date on 07...
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Patient received 2nd dose of Pfizer at 10:14 am on left deltoid, lot # ER8729, expiration date on 07/2021. Patient reports no adverse reaction to first dose of Pfizer vaccine. Patient has history of epilepsy, stroke, hemiplegia left upper extremity. Patient takes medication daily for seizure, medication was last taken this morning. At 11:37 am, patient started to have a seizure in the chair. The three EMTs, and a RN responded immediately. No fall occurred, no clusters in observation room. At 11:38 am, EMS was activated. Patient remained in chair throughout seizure and was physically stabilized by EMT . His seizure lasted approximately 1 minute. At 11:38 am, patient was non-verbal, but breathing at a rate of 20 res/min. Patient nodded to respond to neurological assessment. Vital signs were taken every 5 minutes. At 11:38 am, BP 150/77 sitting, HR 103, SpO2 97% RA, RR 20 res/min labored. Patient was transferred to anti-gravity chair with assistance from EMTs. At 11:39 am, patient was able to verbally respond to questions. Patient was alert and oriented to person, place, time and situation. Patient states "I just had a seizure". At 11:42 am, BP 152/98, HR 104, Spo2 at 95%, RR 22 res/min, labored, patient stated "I feel palpitation". Staff approached patient calmly, encouraged deep breathing, provided quiet environment. Upon assessment, patient was alert, oriented X4, clear speech, communicated in Spanish and English. At 11:45 EMS arrived. patient stated "I feel a lot better". Patient was transferred into a gurney and transported to hospital. Emergency responders left with patient at 11:57 am. Patient was accompanied by his brother .
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| 55 | 2021-04-07 | feeling hot, numbness, burning sensation |
I received the vaccine about two - three inches from the center of the muscle and in back of center ...
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I received the vaccine about two - three inches from the center of the muscle and in back of center - it was more in back of deltoid than the front of my deltoid. When I first got the shot, I had a burning sensation from the site of needle to back of neck to behind my ear area. It felt like a burning aching feeling. My ear felt like it was clogged up and aching. I told the medical site about it and the doctor on site said that more likely they hit a nerve. My blood pressure was very elevated. They had me stay to be observed for 45 minutes. I went back to work. I still felt it at night. The next day, I started feeling up my neck and my collarbone and my left side of my face and my head - my face felt tight and my lip felt numb on the left side and I had a slight confusion too. I went to Emergency room. They did CAT Scan and exam. After that, I noticed it was going all the way down my arm, all the left side of my body to toes. It felt like numbness - like neuropathy type feeling. It felt like constant pain. I went to the Urgent Care and they gave me Prednisone steroid (5 days of it) 5 mg to help with inflammation. I took that for the five days. I started noticing a little black bruising on my body. After that, I went to the Urgent Care again and they gave me Naproxen and and Dr gave me more Naproxen to take. He took bloodwork, too. I went to the ER and I was still feeling sick and hot. They said it was anxiety. I am still going through it - I feel it on the spot where I got the shot - and on my neck and on my head and on my left eye and down on my legs a lot - some days are worse than others but not as bad as when I had the first symptoms.
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| 55 | 2021-04-09 | weakness |
Terrible congestion, runny nose that did not stop from Sunday 4/4/21-Saturday 4/10/21 8:00 am, chest...
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Terrible congestion, runny nose that did not stop from Sunday 4/4/21-Saturday 4/10/21 8:00 am, chest, lungs hurt, body aches earlier in week, had to stay in bed on and off all week, no energy, forced myself to eat, severe coughing by Wednesday 4/7/21 which has only stopped on 4/10/21. was most severe Thursday 4/8-Firday 4/9 Could not concentrate all week, even watching tv.
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| 55 | 2021-04-09 | pain in extremity, feeling cold, tremor |
was in the hospital trying to get his potassium up; extreme lower extremity weakness/my legs didn't ...
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was in the hospital trying to get his potassium up; extreme lower extremity weakness/my legs didn't want to work, I had to use a ladder to pull myself up out of the chair; checked his temperature and it was either 101 degree F or 100.1 degree F/running a fever now of 100.1 degrees Fahrenheit; he liked to froze to death in his house; his legs are so sore; chills; shaking; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6204), via an unspecified route of administration, administered in left arm on 23Mar2021 09:00 at single dose for COVID-19 immunization. The patient's medical history included ongoing high blood pressure (began years ago about 10 years ago, states he has no names or lot numbers of the blood pressure pill). The patient's concomitant medications were not reported. On 25Mar2021, the patient experienced chills and shaking. He stated he was probably running a fever but he don't know. On 26Mar2021, he woke up with extreme lower extremity weakness, stating his legs didn't want to work. He had to use a ladder to pull himself up out of the chair. He checked his temperature and it was either 101 degree F or 100.1 degree F. He was running a fever now of 100.1. Patient stated he had the 1st dose on 23Mar2021 and it was about three days ago and then yesterday (26Mar2021) he liked to froze to death in his house which was 80 degrees and he was covered up and had covers on him. He got ready for work today and when he got up his legs did not want to work and it would have been very easy to fall and when he came in, he fell in the door but his legs were so sore and he was running a fever now of 100.1 degrees Fahrenheit on 26Mar2021. Patient had the Pfizer COVID shot in his left arm and had no soreness or anything like that but stated he was in the hospital for three days trying to get his potassium up on an unspecified date and went through sixteen little bags of concentrated potassium and the first potassium bag was on a drip machine. The outcome of the events was unknown. Information on the lot/batch number has been requested.
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| 55 | 2021-04-09 | pain in extremity |
they had a ultrasound done and found out I had a number of clots in that position; a sore Leg, Upper...
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they had a ultrasound done and found out I had a number of clots in that position; a sore Leg, Upper part of the left calf 2 inches below the knee on the backside; This is a spontaneous report from a contactable consumer. A 55-years-old male patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 18Mar2021 15:00 (Batch/Lot Number: En6207) as SINGLE DOSE for covid-19 immunisation. Medical history included Treatable Acid reflex, anxiety and mild depression. Concomitant medications included omeprazole, buspirone and alprazolam for unspecified indication. Patient had the Covid shot on 18Mar2021 at about 3 PM the next morning (on 19Mar2021 06:00) patient woke up with a sore Leg, Upper part of the left calf 2 inches below the knee on the backside. After it did not go away, he went to the doctor then they had a ultrasound done and found out he had a number of clots in that position. Treatment received for the adverse event includes they put patient on a blood thinner. Prior to vaccination, was the patient did not diagnose with COVID-19. Since the vaccination, the patient has been tested for COVID-19. patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 24Mar2021. Covid test post vaccination done via nasal Swab, They had the results in 15 minutes, covid test result Negative, ultrasound scan: clots in that position on 19Mar2021 found out, had a number of clots in that position. Outcome of the events was recovering.
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| 55 | 2021-04-12 | numbness, slurring |
Starting slurring speech, right arm went numb and right side of face was not responding. Went to ER...
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Starting slurring speech, right arm went numb and right side of face was not responding. Went to ER and they confirmed he was having a stroke. Continued to have multiple strokes at ER from 8:40pm last one was 1:30am (4 hours after clot buster given). Cause of stroke is still undetermined no clots found, no high blood pressure and no high chlorestrol.
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| 55 | 2021-04-12 | pain in extremity | Ache leg muscles and lower back Ankle, knee and hip joints ache |
| 55 | 2021-04-12 | speech disorder |
On 4/8/21 patient reported increased difficulty speaking, increased dizziness, and vision changes. ...
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On 4/8/21 patient reported increased difficulty speaking, increased dizziness, and vision changes. Reports new headache rated 8/10 that started at 11am 4/8. Hx of stroke 2018 with residual right side symptoms. BP 162/104, HR 80, O2 sat 97% room air at 1740. Sent to a Medical Center ER and admitted with stroke symptoms and new onset diabetes.
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| 55 | 2021-04-13 | bell's palsy | left side BELLS PALSY treated with PREDNISONE |
| 55 | 2021-04-13 | tingling |
Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Joint Pain-S...
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Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Joint Pain-Severe, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.), Additional Details: patient called said pain from vaccine hurts badly had to go to doctor and now see physcial therapist; claims was given too high on arm
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| 55 | 2021-04-14 | weakness | Fever, dizzy, loss of bladder control, killer head ache, weak. |
| 55 | 2021-04-14 | tingling |
Left arm pain at injection area and tip of shoulder. Also pins and needle feeling in left hand fing...
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Left arm pain at injection area and tip of shoulder. Also pins and needle feeling in left hand fingers.
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| 55 | 2021-04-14 | tremor |
Lower leg swelling from below knee to top of foot at ankle. Very angry red and swollen. Causing feve...
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Lower leg swelling from below knee to top of foot at ankle. Very angry red and swollen. Causing fever shakes and fatigue. Taking Amoxik Clav 875-125 tab. Nort. Began talking on Tuesday for 3 days with slight improvement.
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| 55 | 2021-04-15 | cold sweat |
few mins after vaccine, felt clammy, dizzy. staff notified, assisted patient to floor to put feet on...
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few mins after vaccine, felt clammy, dizzy. staff notified, assisted patient to floor to put feet on chair. few mins later assisted to stretcher and taken to obs. in trendelenberg. states was anxious about vaccine. bp 155/71 hr 86 rr 20 sats 95%. water and snacks provided, sat up, bp 172/68 hr 86, rr 18, sats 98% on ra; stated he hadnt taken his noon lisinopril yet and still pretty anxious. after resting, bp 167/81 hr 87, requesting to leave with spouse. escorted to exit with no further issues, instructed to take lisinopril once home.
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| 55 | 2021-04-15 | numbness, tingling | Pt c/o whole boy numbness and tingling. |
| 55 | 2021-04-15 | numbness, tingling | Pt with c/o whole body numbness and tingling. |
| 55 | 2021-04-15 | pain in extremity |
I received the first Pfizer injection Tuesday, April 13th. I had signed up for the 12:15 slot, but ...
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I received the first Pfizer injection Tuesday, April 13th. I had signed up for the 12:15 slot, but when I arrived it was like a cattle call. I arrived in time for what I thought was a 12:15 appointment but ended up standing in line for an hour before actually getting the shot. I was fine the rest of that day aside from developing soreness in the muscles of my right arm. The following morning, Wednesday, April 14th, I was awakened to very noticeable soreness in both arms and the back of my neck. As the morning progressed, I developed flu-like symptoms, complete body aches, chills, fever, slight nausea, blurred vision, mild diarrhea.
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| 55 | 2021-04-15 | pain in extremity |
Following day a sore arm and lethargic. 3 days after developed a very foggy mind unable to process ...
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Following day a sore arm and lethargic. 3 days after developed a very foggy mind unable to process information, headache severe at times. Severe joint pain throughout body. Nauseous minimal but there. Anxiety very severe at times . 7 days post symptoms remain and elevated anxiety, tired, lethargic, unable to focus, panic attacks, debilitating at times. Woken up from deep sleep still 7 days post of incredibly severe arm pain in arm hat was injected.
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| 55 | 2021-04-16 | muscle spasms |
On April 16 had absence seizure. I have not had one in over 7 months and felt no warning or precurs...
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On April 16 had absence seizure. I have not had one in over 7 months and felt no warning or precursors. That night fatigue, chills (freezing) headache, nausea, foggy thinking, tense shoulder neck muscles, foot cramps. Day of 17th (ongoing) fatigue, tense shoulders/neck/ lack of hunger, foggy thinking, headache went away with Ibuprofen and Tylenol. Have ate yet so unsure of nausea.
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| 55 | 2021-04-16 | muscle spasms |
Instant onset Sharp headache, spiked fever, cramping, nausea, with all adverse events intensifying o...
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Instant onset Sharp headache, spiked fever, cramping, nausea, with all adverse events intensifying over a 30 minute period
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| 55 | 2021-04-16 | pain in extremity | -pain in left arm -dizziness starting on 4/10/21 to current date |
| 55 | 2021-04-17 | bell's palsy, facial paralysis | Bell's Palsy - face drooped, couldn't keep eye open, left nostril ran only |
| 55 | 2021-04-17 | facial paralysis, slurring |
Facial paralysis on right side; Inability to see or focus and many more serious conditions sppeared ...
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Facial paralysis on right side; Inability to see or focus and many more serious conditions sppeared 20-30 approx; Inability to see or focus and many more serious conditions sppeared 20-30 approx; slurred speech; confusion; This is a spontaneous report from a contactable consumer reporting for himself. A 55-years-old male patient received the first dose BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, at School or Student Health Clinic, via an unspecified route of administration, administered in right arm on 29Mar2021, at 55 years of age, (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included allergy to penicillin and sulfa since an unknown date. The patient was not diagnosed with COVID-19 prior to vaccination and he has not been tested for COVID-19 since the vaccination. The patient's concomitant medications were not reported. On 29Mar2021 at 12:00 the patient experienced facial paralysis on right side, inability to see or focus and "many more serious conditions appeared 20-30 approximately after injection", slurred speech and confusion, all assessed serious for disability. The patient visited his doctor and was prescribed with unspecified medications and a brain scan. The brain scan was performed on an unknown date and no result were provided. At the time of the report the reported events had not resolved yet. Information on the lot/batch number has been requested.
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| 55 | 2021-04-17 | tremor, pain in extremity, feeling hot |
cerebral palsy in my left hand and it seems to be a better; left hand started hurting; couldn't move...
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cerebral palsy in my left hand and it seems to be a better; left hand started hurting; couldn't move fingers; my whole hand swelled a little bit; hand had like a slight fever to it, it was warm; chills my whole hand like it's going down; little jerks in my hands; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EP6955; Expiration Date: 30Jun2021), dose 1 via an unspecified route of administration, administered in Arm Right on 24Mar2021 (at the age of 55years) as single dose for Covid-19 immunization. Medical history included Chronic obstructive pulmonary disease (COPD), heterotaxia (Situs inversus), ankylosing spondylitis, back problem, and cerebral palsy; all from an unknown date and unknown if ongoing. Concomitant medications included diazepam, methocarbamol, meloxicam, salbutamol (ALBUTEROL), and unspecified muscle relaxant; all taken for an unspecified indication, start and stop date were not reported. The patient reported side effects that has official after taking the COVID shot (confirmed as Pfizer COVID Vaccine). The patient stated "I've got cerebral palsy in my left hand and it seems to be a better connection in my left hand, I can now, it's easier for me to pick up small objects and I used to have problems doing that. It is like, I am messenger pain is eating my nerve endings. But here's what happened, 2 days after taking the shot around 26th, I took the shot on 24thMarch, 2021; I took Diazepam, Meloxicam and muscle relaxer (captured as unspecified medication) for back problem. I don't even know if it had anything to do with it, might be just been all the shot, but methocarbamol too. I took those 3 drugs, 2 hours after that, my whole hand, my whole left hand, just my left hand started hurting (further clarification unknown hence captured as suspect conservatively). In my left-hand kind of after feeling and I couldn't move my fingers as well. And afterwards it was in March, it started hurting, my whole hand swelled a little bit. It had like a slight fever to it, it was warm, and it swelled up just slightly not up here, nothing big. I still can't put in my ring, but it was slightly bigger than what it is today, and this hurt. It felt like, I've chills my whole hand like it's going down. So, I work it out, I stretched it, that helped the pain so I could work with them during my fingers stopped working it out. And then afterwards I found out I could, my hands were moving better, it works better. Before I've like little jerks in my hands, you know my hand wouldn't do what I wanted it to do. What I wanted to do more, I can press button, I can pick up smaller objects. It's not 100 percent better, it's not as good as my right hand which had no cerebral palsy in it but it's a lot better than it was. So, I just wanted to report that." The outcome of events was unknown.
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| 55 | 2021-04-18 | pain in extremity |
Pain in left jaw bone / joint area 4 days after vaccine shot; pain / soreness in left arm & shoulder...
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Pain in left jaw bone / joint area 4 days after vaccine shot; pain / soreness in left arm & shoulder area; overall feeling of tired
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| 55 | 2021-04-19 | feeling hot, tingling, flushing |
Approximately 48 hours after shot I started feeling very warm flush and experiencing tingling in han...
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Approximately 48 hours after shot I started feeling very warm flush and experiencing tingling in hands and feet. No fever, headache or joint pain. Also just not feeling like myself. Lack of concentration, agitated, general fatigue. Hand and feet tingling has been worse and night and causing interrupted sleep. This feeling has not gone away and I'm now past two weeks since shot and Wondering if I should get second dose.
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| 55 | 2021-04-19 | muscle spasms, pain in extremity |
Patient was diagnosed with deep venous thrombosis 11 days after receiving Pfizer Covid-19 vaccine. ...
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Patient was diagnosed with deep venous thrombosis 11 days after receiving Pfizer Covid-19 vaccine. Patient developed L leg pain and swelling 3 days after vaccine. First notice pain with swimming when he felt a cramp. Over next few days leg became painful while walking on it. He had no shortness of breath or trouble breathing except for a brief time while he was swimming and felt as if he was slightly shorter of air than normal. He has had no injury to the leg that he can remember. He has not been immobilized or gone on long trips lately. Patient was diagnosed with DVT on 4/13. Patient was started on Xarelto
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| 55 | 2021-04-19 | muscle spasms, pain in extremity |
Patient developed pain and swelling in Left leg on 4/5/21. He first noticed it when he was swimming...
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Patient developed pain and swelling in Left leg on 4/5/21. He first noticed it when he was swimming and felt a cramp to his leg. Over time it began hurting when he walked on it. He has had no shortness of breath or trouble breathing except for a brief time while he was swimming and felt as if he was slightly shorter of air than normal. Patient was positive for DVT and started on Xarelto
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| 55 | 2021-04-19 | pain in extremity | Fatigue, sore arm, muscle aches, low grade fever overnight |
| 55 | 2021-04-21 | pain in extremity, weakness, numbness |
Pain and numbness in right arm. Loss of strength. Been taking otc Tylenol, sometimes otc ibuprofen....
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Pain and numbness in right arm. Loss of strength. Been taking otc Tylenol, sometimes otc ibuprofen. Recently prescribed 800mg ibuprofen but have not taken any at present time
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| 55 | 2021-04-21 | pain in extremity |
He got the vaccine, he had no issues at all. Then on Friday evening 4/16/21 around 6:00 PM he start...
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He got the vaccine, he had no issues at all. Then on Friday evening 4/16/21 around 6:00 PM he started having no appetite, he's having delusions/awareness of what's going on, headaches, light headedness. He still having soreness of the arm. He is having difficulty walking due to the dizziness. He is also having some coughing and congestion issues. He has a history of alcoholism and smoking. Has not taken anything for these symptoms, no insurance and trying to deal with it on his own to see if it would go away.
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| 55 | 2021-04-21 | tingling |
Patient received vaccination at 10:32 am. Patient stated he began feeling tingly sensation to eyes a...
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Patient received vaccination at 10:32 am. Patient stated he began feeling tingly sensation to eyes after 10:42 am. Vital signs taken. BP 118/88, pulse 67, RR 16, oxygen saturation 97. No signs of distress noted. Patient offered water, but declined and continued drinking his coffee out of mug. 10:45am patient states tingling in eyes has lessened. 10:52 am patient states tingling completely gone. Patients states it is not unusual for him to experience tingling sensation in the knees when changing positions occasionally.
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| 55 | 2021-04-21 | tingling |
Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Patient described ...
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Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Patient described tingling around mouth. No swelling of mouth or lip color change, nor were there any changes in speech. Patient accepted a Benadryl and 10 minutes later, the tingling subsided. Patient is waiting the full advised 30 minutes after shot and is doing well. Patient's wife will drive him home.\r\n
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| 55 | 2021-04-22 | weakness |
Patient Sick- Can?t get up, Fever, chills, Had Covid Shot yesterday. T 101.0-.5-6 P 72 R 32 BP 150/...
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Patient Sick- Can?t get up, Fever, chills, Had Covid Shot yesterday. T 101.0-.5-6 P 72 R 32 BP 150/80 Sat 92 % ?no strength.? Hospitalized on 4/9/2021 with Sickle Cell Crisis
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| 55 | 2021-04-22 | weakness |
Shoulder swelled and became sore. Eventually whole body became sore, weak, hot and sleepy. Developed...
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Shoulder swelled and became sore. Eventually whole body became sore, weak, hot and sleepy. Developed fever/chills 99.5. Headache all day. Cough for about two hours. Symptoms faded overnight. No treatment.
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| 55 | 2021-04-23 | feeling cold |
fever; Feeling cold; This is a follow up spontaneous from a contactable consumer. This 55-year-old m...
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fever; Feeling cold; This is a follow up spontaneous from a contactable consumer. This 55-year-old male consumer reported that the patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, LOT number: unknown), via an unspecified route of administration on an 10Feb2021 5.00 (Age at vaccination:55-year-old) at single dose for Covid-19 immunization. The patient's medical history and concomitant medications was not reported. The patient did not have anything done on Thursday, but on Friday evening he got a fever and that was right after 2 days of getting the vaccine and he still has a fever. So, Friday night, Saturday night, Sunday night he had fever and on Monday morning he still has it. It goes down when taking Tylenol. Temperature went as high as 100.7.This morning he didn't have any fever, it was 97.9 and now it's at 98.9. He is also feeling cold. The patient wants to know if this is normal or is it because of the vaccine or did he actually get Covid after the shot. Could it be flu or anything, should he get Covid testing. On 10-Feb-2021, the patient was feeling cold and 12-Feb2021 the patient had fever. The patient was taking Tylenol for fever since 12Feb2021, and Tylenol therapy was still ongoing. The outcome of the events was reported as nor recovered. Information about lot/batch number has been requested.
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| 55 | 2021-04-23 | night sweats |
I had pain at injection site, mild night sweats, and increased tinnitus (I have had tinnitus for man...
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I had pain at injection site, mild night sweats, and increased tinnitus (I have had tinnitus for many years) the night of / after the first and second shots (03/26/21 and 04/16/21) After the second shot, I had less pain at the injection site, mild body aches, and increased tinnitus the night of the second injection. However, the real reason I am reporting this is because after the second dose, the increased tinnitus continued intermittent, usually in the evenings. The tinnitus became especially pronounced on day 2 or 3, 4, 5 and day 8 - the ringing became so loud on the evening of day 2 that it seemed I was having trouble hearing the television. And on the evening of day 8 after the second dose, the tinnitus again became quite loud, with the additional symptom that external noises were annoying / irritated me. I have had constant tinnitus for at least 20 years, and it almost never bothers me (or is even noticeable.) However, the tinnitus symptoms after the second Pfizer shot were pronounced enough that I thought I would report it. Of course, I can't be sure the tinnitus symptoms - especially those at days 4, 5 and 8 - are indeed side effects of the second dose of the Pfizer vaccine, but since I had increased tinnitus symptoms the night after both the first and second Pfizer doses, it would seem to me to probably not be a coincidence.
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| 55 | 2021-04-24 | weakness |
feeling dizzy when he went to bed/dizziness occasionally throughout the day; feeling weak; a little ...
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feeling dizzy when he went to bed/dizziness occasionally throughout the day; feeling weak; a little bit out of breath; This is a spontaneous report from a contactable consumer. A 55-year-old male patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 55 years old on 02Apr2021 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced feeling dizzy when he went to bed/dizziness occasionally throughout the day on 02Apr2021, feeling weak in Apr2021, a little bit out of breath in Apr2021. The patient was calling on behalf of her husband, the patient had first dose on 02Apr2021 and started feeling dizzy when he went to bed that night, he's dizzy when laying down in bed sometimes it woke him up, he had dizziness occasionally throughout the day and he was also feeling weak and a little bit out of breath. The patient was concerned on getting second. The outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
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| 55 | 2021-04-25 | bell's palsy | Bell's palsy. |
| 55 | 2021-04-25 | burning sensation | At 7:00 pm feeling burning sensation on upper lips with bumps |
| 55 | 2021-04-25 | difficulty speaking |
Dysphora lose of appetite unable to preform routine work tasks unstable on feet unable to drive safe...
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Dysphora lose of appetite unable to preform routine work tasks unstable on feet unable to drive safely removed from work position
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| 55 | 2021-04-25 | flushing |
As the client was exiting the vaccination hallway, the client informed a vaccinator that he felt tin...
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As the client was exiting the vaccination hallway, the client informed a vaccinator that he felt tingling in his mouth, was experiencing an indescribable taste and his eyes hurt. The client looked flushed. The client was instructed to lay on a mat on the floor. Client drank some juice and ate some pretzels. After 20 minutes he reported that he was no longer experiencing any symptoms. As the client was standing up he reported that he felt dizzy but this resolved as he walked around the room. He then wanted to sit outside so two nurse's went with him . After 40 minutes he reported that all of his symptoms had resolved. We followed up with the client on 4/25/21 and the client reported that he had not experienced any additional symptoms.
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| 55 | 2021-04-25 | night sweats, tremor |
12 hours after receiving the second Pfizer Covid 19 vaccination dose, I started getting chills and b...
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12 hours after receiving the second Pfizer Covid 19 vaccination dose, I started getting chills and body shakes for about 24 hours. I had significant night sweats waking up completely soaked. I measured a fever at 101.7 in the morning of the next day after the dosing of 2 advils clearly had worn off. I continued to take 1 advil every 4 -6 hours when i noticed getting chills again until the afternoon on 4-25-2021 when I started to feel better. i had no other sideeffects with the exception of body aches which I contribute mostly to staying in bed for over 24 hours.
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| 55 | 2021-04-27 | pain in extremity |
Sore/achy arm.; This is a spontaneous report from a contactable consumer (patient). An 55-year-old m...
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Sore/achy arm.; This is a spontaneous report from a contactable consumer (patient). An 55-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE (age at vaccination was 55 years), solution for injection, lot number: EN6207 and expiry date was not provided), via an unspecified route of administration in the left arm, on 25Mar2021 at 10:00, as single dose for COVID-19 immunisation. Medical history included allergy with penicillin. Patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. On 25Mar2021 at 15:30, the patient had sore and achy arm. Treatment mediations were not reported. Outcome of the event recovered in Mar2021.
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| 55 | 2021-04-27 | tingling, numbness |
right leg numb in the following areas, right buttocks, right calf, and right side of foot. After se...
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right leg numb in the following areas, right buttocks, right calf, and right side of foot. After several days is was just the foot. After second shot numbness continues.. It felt like something had fallen asleep, like when you set on your leg wrong.
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| 55 | 2021-04-28 | numbness, pain in extremity, tenderness |
LEFT LOWER EXTREMITY ISCHEMIC LIMB; ARTERIAL THROMBOSIS A week after the first dose, patient develop...
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LEFT LOWER EXTREMITY ISCHEMIC LIMB; ARTERIAL THROMBOSIS A week after the first dose, patient develop acute onset of left 3rd toe tip pain and tenderness.This gradually progressed to pain under his metatarsal head in the left foot. Gradually over the last 2 weeks, he has also noted increasing hip and buttock muscle fatigue with walking. Two nights ago, he developed increasing pain in his left forefoot. Yesterday, his left foot became numb and he went to Medical Center for evaluation. While there, he was found to have an ischemic left leg with lack of Doppler signals in his left foot and subsequently underwent CT angiography. This CT scan demonstrated left internal iliac occlusion, partially occlusive thrombus within the left external iliac artery with widely patent femoral popliteal system bilaterally. However, his left peroneal and anterior tibial arteries were occluded for segments, while the distal left posterior tibial artery appears occluded, although this may represent contrast bolus timing issues He has no known prior history of thrombotic issues. He has no family history of clotting abnormalities. He denies any palpitations or history of cardiac arrhythmia. He has been in sinus rhythm since his initial presentation.
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| 55 | 2021-04-28 | numbness | Bilateral facial numbness, persistent, unknown etiology, x2 normal MRI, normal MRA |
| 55 | 2021-04-28 | muscle twitching |
Upon second dose I have constant twitching at and around injection site of left upper arm, it is ver...
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Upon second dose I have constant twitching at and around injection site of left upper arm, it is very disturbing and persists to this moment. I noticed it about 24 hours after the shot. I also have the totally normal soreness at the injection site that persists to this moment. I did have flu like symptoms (body aches, limb weakness arms and legs, malaise) on 4/28/21 from 1pm till 9pm but has resolved. The First shot I do not remember which arm, I think it was the left but cannot be certain, but I had no side effects at that time. I also have a very occasional twitch in my right upper arm that persists to this moment which is similar to the twitch in my left arm but is much much less severe and very infrequent. Note I have specifically nickel allergy and a number of other minor allergies. I also used to have benign fastulations that were random though my body which resolved and has not been an issued since 2017.
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| 55 | 2021-05-03 | numbness |
numbness in the left foot after the covid-19 vaccine. I still have the numbness from April 17, 2021...
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numbness in the left foot after the covid-19 vaccine. I still have the numbness from April 17, 2021, to this day.
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| 55 | 2021-05-03 | pain in extremity |
Afib; sometimes sharp and sometimes dull pains that would last 10-60 seconds throughout her body-cal...
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Afib; sometimes sharp and sometimes dull pains that would last 10-60 seconds throughout her body-calfs, things, forearms, toes, finger and even his stomach; sometimes sharp and sometimes dull pains that would last 10-60 seconds throughout her body-calfs, things, forearms, toes, finger and even his stomach; sometimes sharp and sometimes dull pains that would last 10-60 seconds throughout her body-calfs, things, forearms, toes, finger and even his stomach; This is a spontaneous report from a contactable consumer (patient). A 55-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 03Mar2021 (Batch/Lot Number: EN6198) (age at vaccination: 55-year-old) as SINGLE DOSE for covid-19 immunisation. The patient's medical history was not reported. Concomitant medications included nebivolol nebivolol hydrochloride (BYSTOLIC) taken for an unspecified indication from 2013 and ongoing; doxycycline (ORACEA) taken for an unspecified indication from Jul2020 and ongoing. Historical vaccine included first dose of bnt162b2 (Batch/Lot number: EC9269) on 02Feb2021 as single dose in Left arm for covid-19 immunisation. The patient had been experiencing pains on and off for about5-6 days after his first slot. Then he read an article (he swear, he was not researching anything online) about a 56 year old man who developed ITP days after receiving Pfizer vaccine. since he had Afib this article worried him. He had no idea what blood clots felt like, but he was having sometimes sharp and sometimes dull pains that would last 10-60 seconds throughout her body-calfs, things, forearms, toes, finger and even his stomach. The doppal came back negative. The doctor suggested symptoms finally disappeared for good about two days after his second dose. The outcome of the events was unknown.
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| 55 | 2021-05-04 | pain in extremity |
About 12 h after vaccination, I got headache, chills, body aches and low fewer which lasted until ne...
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About 12 h after vaccination, I got headache, chills, body aches and low fewer which lasted until next day; About 12 h after vaccination, I got headache, chills, body aches and low fewer which lasted until next day; About 12 h after vaccination, I got headache, chills, body aches and low fewer which lasted until next day; About 12 h after vaccination, I got headache, chills, body aches and low fewer which lasted until next day; This is a spontaneous report from a contactable consumer (reported for himself). A 55-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: unknown) via an unspecified route of administration on 16Feb2021 at 07:45 as SINGLE DOSE (at the age of 55-years) in left arm for covid-19 immunization. Medical history included high cholesterol. The patient had no known allergies. Historical vaccine included: the patient received first dose of bnt162b2 via an unspecified route of administration on 26Jan2021 at 07:30 as SINGLE DOSE (at the age of 55-years) for covid-19 immunization. The patient did not receive any other vaccine in four weeks. Concomitant medications included: atorvastatin (Lipitor), diphenhydramine hydrochloride (Benadryl), Ibuprofen and unspecified multivitamins. Prior to the vaccination the patient was not diagnosed with COVID-19. On 16Feb2021 at 20:00, about 12 hours after vaccination, the patient experienced headache, chills, body aches and low fewer which lasted until next day. It was reported that there was no treatment for events. Since the vaccination the patient had not been tested for COVID-19. The outcome of the events was recovering.
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| 55 | 2021-05-06 | night sweats |
Coughing blood; Trouble Breathing; Lungs Damaged; Coughing; Headache; Fever; Body Shakes a Lot with ...
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Coughing blood; Trouble Breathing; Lungs Damaged; Coughing; Headache; Fever; Body Shakes a Lot with Cold; Night Sweats, states it is like he took a shower; Diarrhea, states when he goes to the bathroom, it is water; Lost 14 Pounds; felt really bad; This is a spontaneous report from a contactable consumer reported for himself. A 55-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left at 55 years old on 06Apr2021 08:45 (Lot Number: ER8733; Expiration Date: 31Jul2021) at single dose for covid-19 immunisation. Medical history included ongoing high blood pressure, diagnosed 20 years prior to the report. The patient's concomitant medications were none. There were no other vaccines Administered on Same Date of the Pfizer Suspect or within 4 weeks. The patient experienced coughing, headache, fever, body shakes a lot with cold, night sweats, states it is like he took a shower; diarrhea, stated when he went to the bathroom, it was water, coughing blood, trouble breathing, lungs damaged, lost 14 pounds, all on 06Apr2021. Patient stated he was calling because his doctor told him to call. Stated he got his first injection on 06Apr2021. Told to sit for 15 minutes, and he felt fine and went to work and felt really bad after 1 hour; 09:45-10:00. Since then he had been super sick and at the hospital 3 times, later confirmed ER, not hospitalized. Patient stated the doctor also told him his lungs are damaged and they were sending him to see a specialist. Patient was asking what was going on with his body, is this a normal reaction? Stated his doctor said to call because it had been too long, stated usually it lasted 2-3 days and with Tylenol, it was gone, then it should be clear, but it had been almost 16 days for him. Stated one hour after his injection, he started feeling really bad. Stated he was coughing up blood from coughing so much. Stated he was 154 pounds, but he has lost 14 pounds. Patient stated his first injection was on 06Apr2021. Stated his second vaccine is supposed to be on 28Apr2021 but he was not going because he was afraid to go back in case it got worse. Treatment received for the events included 3 Different Antibiotics; Tylenol and Drinking Hot Tea. Patient clarified that he has had 3 Emergency Room Visits (10Apr2021, 19Apr2021, and 20Apr2021), Physician Office on 21Apr2021, but he was never admitted to hospital. Patient stated one time they kept him in the ER for 20 hours. Patient stated once he went to Hospital and then yesterday and the other day, he went to Hospital because he was having trouble breathing. The outcome of the events was not resolved. No follow-up attempts are needed. No further information is expected.
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| 55 | 2021-05-07 | facial paralysis, bell's palsy | Parálisis facial en el lado derecho ( Bell palsy ) |
| 55 | 2021-05-07 | muscle spasms, pain in extremity, numbness |
Extreme fatigue; Back of knees were cramping; Small bruise marks; Upper right arm inside he could se...
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Extreme fatigue; Back of knees were cramping; Small bruise marks; Upper right arm inside he could see all of his veins; Head rush; Felt like he was going to spazz out; Sweating; Diarrhea; Headache and pressure at his temples; His ears were ringing; Left arm pain from injection site; Drop foot; Legs went to sleep; Arms were roided out or supercharged/Forearms did not feel like his blood was right; Difficulty/pain breathing in the upper chest; Difficulty/pain breathing in the upper chest; Pretty big at the base of his left index finger, red spot; Pain in the right thumb base/Pain in base of right foot; He felt like he was going to die 5 times; Thought he was having a stroke; Heart rate would go up or be faint; Lost four pounds during this, and gained one back; Stiff right arm/Left thigh was stiff; Thrashing event; Heart rate went up; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported, expiration date: 28Mar2021) via an unspecified route of administration on left arm 24Mar2021 10:00 at single dose for covid-19 immunization. Medical history included cytomegalovirus from on an unspecified date 2010 and Palpitations. The concomitant medications were not reported. The patient reported, he has gained back a pound and that he is starting on the road to recovery in the last week. Stiff right arm lasted the first and second week. It started the first day of when he got the shot. The next morning, he calls a thrashing event where he felt like his limbs would not work. They did work, but it felt like he needed to move them around. He was thrashing in bed and making the motion with his big joints, then getting into the small joints. It was his arms and legs. Over the course of like an hour, his heart rate went up to like 120. He does not qualify this as racing, but his heartrate is normally 60. This was several times over the course of the first week so it would have been around 04Apr2021 or 03Apr2021. Events occurred 9 days later, which is what he is considering this first week. His left arm was where he got the vaccine, but his right arm was stiff. He felt like he was going to die 5 times. He also had extreme fatigue. He never went to the emergency room. At this time, his glucose was high and his zinc was low. The doctor thinks the extreme fatigue was the antibodies reacted to the cytomegalovirus. He adds that the back of his knees was cramping in the first and second week. In the right arm, he had some small very small bruises. His forearms did not feel like his blood was right. He does not know how to describe it, but he has had metal slivers in his arm in the past and it felt like that, like an infection. He does not know how to describe it. He adds that in his upper right arm inside, he could see all of his veins, like a roadmap. He also had some other things, like his left side of his head rush, like it felt like blood was rushing from the top to left side of his brain. At dinner and meals he had several instances he could barely sit there, he felt like he was going to pass out or spazz out. His limbs felt like they were going to spazz out. In second week, he had several nights where he sweated a lot overnight. The second week into the third week, he did not have the thrashing stuff anymore but for pretty long his heart would go up a notch and/or the heart would be faint. He had diarrhea when he got up. It did not go up to 120, but maybe 80, Headache and pressure at his temples, ears ringing. Left arm pain from injection site. It started with a bang and really hurt. It was really sore and kind of spread into cramping. It was stiff and the source was the injection site. At work, he thought he was having a stroke. His left leg and thigh were stiff and spreading feeling. About 20 minutes after sitting, his legs did not work, and he collapsed. He had Drop foot when his legs got stiff. It took like a week to retrain his arm and leg, like he had a mini stroke. He did therapy for himself and retrained his arm to play guitar. He had a little bit of stiffness in his left arm that comes and goes, stiffness in his left thigh that comes and goes, and his ears are ringing a little bit and it comes and goes. He is not getting second vaccine. He took zinc per his doctor recommendation, but it did not go well. He felt like his arms were roided out or supercharged. He had difficulty/pain breathing in the upper chest, a pretty big at the base of his left index finger red spot like blood collection, and pain in the right thumb base. He had pain in the base of his right foot. Blood tests were in the second week. Glucose was high and he is hypoglycemic. Glucose 117 mg/dl (79-115 normal range), zinc 54 mcg/dl (60-120 normal range), CMV IGG AB >10 u/mL (positive is > or = 0.7 range). The outcome of the events was unknown.
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| 55 | 2021-05-11 | bell's palsy |
Bell's palsy symptoms started up a few hours after the shot/had it two years ago; Bell's palsy sympt...
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Bell's palsy symptoms started up a few hours after the shot/had it two years ago; Bell's palsy symptoms started up a few hours after the shot/had it two years ago; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration, on 26Apr2021 14:00, as 2nd dose, single, for COVID-19 immunisation. Medical history included Bell's palsy in 2019 (had it two years ago). The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. Concomitant medications included cetirizine hydrochloride (ZYRTEC); and cimetidine (TAGAMET), both taken for unspecified indications, start and stop dates were not reported. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported) at age 55 years, administered in the left arm, on 05Arp2021 14:00, for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. Bell's palsy symptoms started up a few hours after the shot, on 26Apr2021 at 16:00. The patient had it two years ago. The patient was recovering from the event (reported as subsiding 24 hours later). Follow-up needed. Information about batch/lot number has been requested.
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| 55 | 2021-05-13 | pain in extremity |
the pain was shooting down to his heart; severe pain in his left shoulder after that second dose; in...
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the pain was shooting down to his heart; severe pain in his left shoulder after that second dose; injection site pain; pain is around his arms/going on the top of his legs; back and wraps down to the heart; major pain up around his shoulders and around the back of neck; I have stomach problems, I am collapsed stomach; This is a spontaneous report from a contactable consumer (patient). This 55-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in his left arm on 05Apr2021 at single dose for COVID-19 immunisation. Medical history included Arthritis, Sinus problem, Asthma, Bipolar disorder. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 on unspecified date at age of 55 years old for COVID-19 immunisation. The patient experienced injection site pain, severe pain in his left shoulder after that second dose. Some major pain up around his shoulders and around the back of neck, his left side was worst. He said that the pain was shooting down to his heart. So he went to the hospital because he thought it was something to the heart. They tested him, they evaluated him but they ruled out anything that has to do with the heart. They checked his heart, he had a cardiac catheterization, and was ruled out, everything came out negative. So, he just got out of hospital and was still developing the pain and it's on his left side, it's on his right side (as reported). He called all his doctors, they had no answers for him, now he was still in a lot of pain in both of shoulders like he was saying his left side was still the worst, and it has not gone away and the pain is still shooting down around his heart and shooting down around the back of neck and now it's going on the top of his legs. He went to the bone doctor and he was getting an MRI done, because the doctors said nothing was torn in his arms or tissues. He stated the pain was around his arms, back and wraps down to the heart. He was in dire pain, 8.5/10 and had a feeling of it was related to the vaccine. He clarified the pain was in both shoulders and the left side was worse and that was the side he had his shot on. Patient stated he had stomach problems, he was collapsed stomach. The outcome of events was unknown. Information on the lot/batch number has been requested.
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| 55 | 2021-05-13 | tremor |
Pulmonary embolism in his left lung; Chills; Hard to breathe; shaking a lot; This is a spontaneous r...
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Pulmonary embolism in his left lung; Chills; Hard to breathe; shaking a lot; This is a spontaneous report received from a contactable consumer (patient). A 55-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: EW0164) via an unspecified route of administration on 19Apr2021 at 12:00 (at the age of 55-years-old) as a single dose in the left shoulder for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD) from an unspecified date and ongoing and urinary tract infection (UTI) from an unspecified date and unspecified if ongoing. Concomitant medications were reported as none. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: first letter is either a G or O but he thought it was OE8732) via an unspecified route of administration on 29Mar2021 at 11:45 (at the age of 55-years-old) as a single dose in the left shoulder for COVID-19 immunisation. Illness at vaccination was UTI. On 20Apr2021 the patient experienced pulmonary embolism in his left lung, chills, hard to breathe and shaking a lot. The patient was hospitalized for pulmonary embolism in his left lung (blood clot) from 20Apr2021 to 26Apr2021. The clinical course was reported as follows: The patient stated that he had the second Pfizer shot on 19Apr2021 and on the 20Apr2021 he had a really bad reaction to it. He had chills, it was hard to breath, he was shaking a lot and had a UTI and COPD and had to call an ambulance to come get him. When he went to the emergency room, they did a CT (computerized tomography) scan of his chest and found a pulmonary embolism in his left lung and he was put on a Heparin drip for 7 days and stayed in the hospital for 7 days. The event hard to breathe ended shortly after he got to the emergency room since he was on oxygen. The patient had a history of COPD, so sometimes he had trouble breathing, but right now he did not. The event shaking a lot ended a little after he got to the emergency room. The patient also stated that he had a history of UTI in the past and had a UTI during the vaccine but was not treated for the UTI until he was at the hospital. The clinical outcomes of the event pulmonary embolism in his left lung was unknown; chills, hard to breathe and shaking a lot were all recovered/resolved on 20Apr2021.
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| 55 | 2021-05-15 | cold sweat, pain in extremity |
pain in arm, within 5 days-very tired and no apatite, fever/chills/cold sweats. within 30 days, sin...
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pain in arm, within 5 days-very tired and no apatite, fever/chills/cold sweats. within 30 days, sinus tachycardia, low Sp02, started having a cough. Sepsis secondary to severe right lung necrotizing pneumonia with empyema, hospitalized for 5 days. Discharged with a right chest tube with Pleur-evac. Will require at least 6 weeks of antibiotics.
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| 55 | 2021-05-19 | burning sensation | severe fever, chills, burning headaches. |
| 55 | 2021-05-21 | bell's palsy, numbness |
the muscles in my face felt weak as if I was having an onset of Bell's Palsy; it was a strange feeli...
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the muscles in my face felt weak as if I was having an onset of Bell's Palsy; it was a strange feeling of numbness like a mask covering my face; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 19Feb2021 09:15 as 2nd dose, single for COVID-19 immunization in a clinic. The patient's medical history and concomitant medications were not reported. The patient did not receive other vaccines within 4 weeks of vaccination. Not diagnosed with COVID-19 prior to vaccination and not tested for COVID-19 since vaccination. The patient previously received the first dose of bnt162b2 on 29Jan2021 09:45 PM (lot number: not provided), at 55 years old in the right arm for COVID 19 immunization. On 19Feb2021 10:45 AM, the patient had muscles in his face felt weak as if was having an onset of Bell's Palsy. The patient reported that he never lost use of his muscles but it was a strange feeling of numbness like a mask covering his face. This lasted for approximately 7 hours. The patient massage and move all his muscles periodically through this event. No treatment was received. The outcome of the events was recovered on 19Feb2021 17:45. Information about lot/batch number has been requested.
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| 55 | 2021-05-23 | tingling |
I received the vaccine in the right arm and within about 20 seconds I felt like I was going to faint...
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I received the vaccine in the right arm and within about 20 seconds I felt like I was going to faint and had rapid heart rate (pulse of 155) measured by EMT. I needed to remove the mask as I was having difficulty with the rapid heart rate and feeling of fainting. I also felt pins and needles type feeling in my legs and my face felt slightly swelled. I felt tired and that tired feeling lasted for the entire day. I stayed at the vaccination site for approximately 30 minutes at the advice of the EMT and went home. Later I had a slight headache but heart rate became more normal.
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| 55 | 2021-05-24 | numbness, tingling |
Complete numbing of the left upper biceps and shoulder with tingling of the left hand and fingers. S...
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Complete numbing of the left upper biceps and shoulder with tingling of the left hand and fingers. Soreness in left shoulder. Has lasted since doses were given.
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| 55 | 2021-05-24 | pain in extremity |
experienced nausea; sore arm at the injection site; sore arm at the injection site; at night felt re...
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experienced nausea; sore arm at the injection site; sore arm at the injection site; at night felt really tired; This is a spontaneous report from a non-contactable consumer (patient himself). A 55-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) via an unspecified route of administration on 15Feb2021 (at the age of 55-year-old) at single dose for COVID-19 immunisation. The patient received the first dose of BNT162b2 on 26Jan2021 at the age of 55-year-old without any side effect. Concomitant medications were not reported. On 15feb2021 after second dose of vaccine the patient experienced sore arm at the injection site and at night felt really tired. On the morning of 16Feb2021 he experienced nausea lasting for a day. On 17Feb2021 the patient felt fine and the events resolved. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 55 | 2021-05-24 | cold extremities, tingling |
Metallic taste in mouth after injection; dizziness; nausea; confusion; cold tingling hands and feet....
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Metallic taste in mouth after injection; dizziness; nausea; confusion; cold tingling hands and feet. Pt states he felt really bad and had the urge to defecate.
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| 55 | 2021-05-25 | feeling hot |
anxiety attack; heart racing; intense feeling of heat in body; tired; shortness of breath; This is a...
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anxiety attack; heart racing; intense feeling of heat in body; tired; shortness of breath; This is a spontaneous report from a contactable other HCP (patient). A 55-year-old male patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 24Apr2021 16:30 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included allergy. There were no concomitant medications and the patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient previously took levofloxacin and experienced allergy. The patient reported that approximately three minutes after taking the vaccine 24Apr2021 16:33 (also reported as 17:15), still waiting for the recommended 15 minutes to be released, he started to feel his heart racing and a very intense feeling of heat in body. After reporting to the nurse at the location, she listened to his heart asking him to take a deep breath several times. According to the nurse, he had an anxiety attack, as she did not show any signs of anaphylaxis. However, he felt very tired and the night with a little shortness of breath. He would like to know if he go for the second dose or look for another vaccine. the patient did not receive treatment for the events and the outcome of the events was resolved in 2021. Information on the lot/batch number has been requested.
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| 55 | 2021-05-25 | pain in extremity |
Right acute lumbosacralplexopathy dx on EMG. Severe pain and weakness right thigh, leg began approxi...
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Right acute lumbosacralplexopathy dx on EMG. Severe pain and weakness right thigh, leg began approximately 3 days post second vaccine. Progressive pain, weakness, atrophy.
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| 55 | 2021-05-26 | involuntary muscle movements, tremor |
Pt was responding well before the injection. After receiving the vaccine, he walked over to the wait...
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Pt was responding well before the injection. After receiving the vaccine, he walked over to the waiting area to sit for his 15 minutes. After a few minutes, pt was seen slumped over in his chair and his phone fell to the floor. Nurse came out to check on him and started rubbing his back. Pt was rocking back and forth in his chair and looked like he was slightly shaking. Paramedics were called. Several seconds later, pt stated he saw spots and felt dizzy and nauseous. Pt was given a cup of water. Then after a few minutes, pt stated he felt better than earlier. Paramedics arrived to assess the pt and took him to the ER for further assessment.
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| 55 | 2021-05-26 | numbness |
Developed. Guillian-Barre type reaction with numbness in bothering feet. Left greater than Right. Le...
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Developed. Guillian-Barre type reaction with numbness in bothering feet. Left greater than Right. Left toes completely numb, top of feet also. Then started developing numbness in tip of finger gets bilaterally. So start and completed 5 injections of IgG
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| 55 | 2021-05-27 | pain in extremity |
Impressive muscular pain after heavy, but normal for me, exercise; odd muscular pain in legs after e...
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Impressive muscular pain after heavy, but normal for me, exercise; odd muscular pain in legs after exercise; This is a spontaneous report from a contactable physician (Patient himself). A 55-year-old male patient received both dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose on 17Dec2020 12:15 (Batch/Lot Number: EG1685) intramuscular in right arm , second dose on 06Jan2021 (Batch/Lot Number: EK9321) (age at vaccination 55 year) intramuscular in arm, both as single dose for covid-19 immunisation. Medical history included coeliac disease from 2009 and IgA nephropathy very mild from 2020, both ongoing. The patient had no allergies. The patient's concomitant medications were not reported. The patient has not received any other vaccine within four weeks and not other medication within two weeks. The patient experienced odd muscular pain in legs after exercise on 10Jan2021 12:00 and on 11Jan2021 12:00 impressive muscular pain after heavy, but normal for patient, exercise. The patient underwent lab tests and procedures which included COVID-19 (Nasal swab) test: negative on. The outcome of event leg pain was unknown, of other event was recovered. Reporter consider that the Pfizer product had not had a causal effect to the adverse event. Follow-up (07May2021): Follow-up attempts completed. No further information expected. Follow-up (PRD 26Apr2021): New information form a contactable physician (patient) included: route of administration, second dose date of vaccine, non serious event myalgia, reporter's causality. No Follow up attempts needed. No further information is expected.; Sender's Comments: The events event leg pain and myalgia considered intercurrent conditions and unlikely related to both both dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose on 17Dec2020 12:15 (Batch/Lot Number: EG1685) intramuscular in right arm , second dose on 06Jan2021 (Batch/Lot Number: EK9321).
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| 55 | 2021-05-28 | weakness |
muscle soreness; flu; headache; chills; weakness; fatigue; difficulty thinking straight; could barel...
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muscle soreness; flu; headache; chills; weakness; fatigue; difficulty thinking straight; could barely stand; could not eat; fever; lots of sweating; muscle fatigue; hard to breath; body aches all over; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19 vaccine), dose 2 via an unspecified route of administration, administered in Arm Left on 11May2021 17:00 (Batch/Lot Number: EW0153) as 2nd dose, single for covid-19 immunisation. Medical history included asthma and samters syndrome. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19. The patient's concomitant medications were not reported. The patient previously took pencillin and aspirin and experienced allergies. On 12May2021 12:30, the patient experienced muscle soreness which is much less and is gone at the time of the report, patient came down with the flu which began around 11:30 am to 12 pm, 20 hours after receiving the second shot. It began with headache, muscle aches, chills, weakness and fatigue. The patient also began having difficulty thinking straight. The patient is a truck driver and was on the road trying to finish up so he just could go home and call in sick. When the patient got out of the truck, he could barely stand as he was so weak. It was both fatigue but also his body had no energy to give. The patient had a hard time getting energy to finish and get ho//2021nt then got home and felt worse, like a full blown flu, could not eat, fever and lots of sweating yet lots of chills all over, weak, headache was worse, body aches all over, hard to breath from muscle fatigue, woke up soaked in sweat. The patient added that he has not felt this bad in years. The patient did not receive treatment for the events. Event muscle soreness was recovered on unspecified date; all other events was recovering. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
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| 55 | 2021-05-31 | pain in extremity |
2 days after receiving the second shot I woke up with throbbing hands and fingers. My fingers and ha...
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2 days after receiving the second shot I woke up with throbbing hands and fingers. My fingers and hands have been swollen and throbbing since the second vaccine. My doctor and myself believe it is rheumatoid arthritis triggered from the vaccine. I will have test done to confirm this in 3 months when I received my healthcare back from my employer... The joints in my fingers feel like they are under attack and I believe this to be the case they were perfectly fine before the vaccine and now I can hardly open a can of pop..
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| 55 | 2021-06-01 | bell's palsy | Bells Palsy |
| 55 | 2021-06-01 | feeling hot |
First dose: soreness in left arm for 1 day. Second dose: Day 1 and 2: Heat sensations from the...
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First dose: soreness in left arm for 1 day. Second dose: Day 1 and 2: Heat sensations from the inside of my body. Opposite of a flu like feeling. Day 1 thru 4: Insomnia
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| 55 | 2021-06-01 | seizure | R56.9 - Unspecified convulsions. |
| 55 | 2021-06-02 | sciatica |
Developed lower back pain, sciatica and skin sensitivity in right hip and leg approximately 10 days ...
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Developed lower back pain, sciatica and skin sensitivity in right hip and leg approximately 10 days after second dose. Managed pain with OTC medications, stretching and massage over ensuing week as symptoms worsened. Approximately nine days following onset of symptoms, began developing blisters in patches on lower right leg. Visited urgent care and confirmed shingles, which is now being treated with valacylovir and predinsone. Symptoms are abating. This is my third bout with shingles as an adult. There is no confirmed linkage to my COVID vaccinations but I thought I should report this as a possible vaccine reaction given the close proximity of shingles onset to my last COVID shot.
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| 55 | 2021-06-03 | weakness, cold sweat |
5:40 am 6/2/2021 awakened to cold sweat. 8:00 am unable to keep morning coffee down. 11:00 eat 1/2 b...
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5:40 am 6/2/2021 awakened to cold sweat. 8:00 am unable to keep morning coffee down. 11:00 eat 1/2 bagel with peanut butter, unable to keep it down. 2:00 and after further attempts at water, saltine cracker, unable to keep anything down 11:00 pm, attempt to drink sparkling water, unable to keep down. No appetite, inability to keep food down and cold sweats after vomiting each occurrence. June 3, once again able to tolerate food, energy low I assume from available energy from lack of food, progressive improvement through the day. Self managed care.
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| 55 | 2021-06-03 | pain in extremity |
About 4 hours after the shot I developed a burst blood vessel on the index finger (midway)of my righ...
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About 4 hours after the shot I developed a burst blood vessel on the index finger (midway)of my right hand, which left a painful purple subcutaneous mark.
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| 55 | 2021-06-06 | tingling |
5d later he began having HA (not related to position or N/V), foggy thinking, short term memory issu...
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5d later he began having HA (not related to position or N/V), foggy thinking, short term memory issues, L hand tingling, L foot tingling, dropping items from left hand, confusion, difficulty multitasking, unsteadiness when walking.
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| 55 | 2021-06-07 | weakness, facial paralysis, speech disorder |
He had a stroke- sudden onset of weakness,- facial drooping, speech impairment, lethargy, and confus...
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He had a stroke- sudden onset of weakness,- facial drooping, speech impairment, lethargy, and confusion obvious symptoms did resolve over 24 hour- he has some residual fatigue and questionable changes post stroke
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| 55 | 2021-06-07 | facial pain, nerve pain |
Shingles to face/outbreak of Shingles; nerve pain to the right side of face and upper right teeth; u...
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Shingles to face/outbreak of Shingles; nerve pain to the right side of face and upper right teeth; upper right teeth are still numb and throb; right side of head hurt; right eye was swollen and almost fully closed; blister; terrible sunburn top of head and entire right side of face; trigeminal neuralgia; additional pain to front upper teeth from center to the right side of mouth; some pain on right side of face above mouth/ lot of pain all to the right side of face/terrible pain right side of face; pain to front upper right tooth/upper teeth ached/terrible pain upper right side of teeth/upper right teeth are still numb and throb; This is a spontaneous report from a contactable consumer (patient). A 55-years-old male patient received second dose of bnt162b2 (Pfizer Covid-19 vaccine, formulation: solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on 15Mar2021 (at the age of 55-years-old) as 2ND DOSE, SINGLE for covid-19 immunisation. The patient received the first dose of bnt162b2 (Pfizer Covid-19 vaccine, formulation: solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on 22Feb2021 as first dose single dose for covid-19 immunisation. Concomitant medication included methylprednisolone (MEDROL [METHYLPREDNISOLONE]) taken for; amoxicillin (AMOXICILLIN) and secukinumab (COSENTYX) taken for psoriasis. On an unspecified date, the patient experienced shingles to face/outbreak of shingles. On 14Apr2021, the patient experienced pain to front upper right tooth. The patient saw dentist and the tooth looked fine. On 17Apr2021, the patient had additional pain to front upper teeth from center to the right side of mouth and some pain on right side of face above mouth. On 18Apr2021, the patient saw three different dentists, and none found any issues with teeth. On 19Apr2021, the patient had terrible sunburn on top of head and entire right side of face, upper teeth ached, having more pain to the right side of my face and the dentist thought he had trigeminal neuralgia. On 20Apr2021, in the evening the patient was in a lot of pain all to the right side of face and contemplated going to the hospital but did not go. On 21Apr2021, the patient woke up in terrible pain (right side of face and upper right side of teeth) and right side of head hurt, right eye was swollen and almost fully closed, and a blister was visible. The patient reported that, he saw a Rheumatologist who diagnosed Shingles and he started taking Valtrex and Gabapentin. The patient also saw an ophthalmologist who prescribed an antibiotic eye drop. The patient reported that, she was in bad shape, which is evident in a picture she took by 23Apr2021. The patient saw an ENT who had sent him back to the ophthalmologist and he consulted with Rheumatologist. The patient reported that, ENT gave him a Medrol Steroid for six days and Amoxicillin. The patient had been suffering greatly since this began. On 10May2021, the patient's swelling has receded, but still had significant nerve pain to the right side of face and upper right teeth and upper right teeth are still numb and throb. Therapeutic measures were taken as a result of herpes zoster, toothache, oral pain and eye swelling. Outcome of the events was unknown. Information on the lot/batch number has been requested.
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| 55 | 2021-06-07 | night sweats | Chills, Sweats all night |
| 55 | 2021-06-08 | pain in extremity |
The day after the shot, the patient got the usual headaches, bodyaches, fatigue, arm soreness, such ...
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The day after the shot, the patient got the usual headaches, bodyaches, fatigue, arm soreness, such that it was difficult to raise his arm, nausea, dizziness and fatigue. That all resolved after two days. He then felt well for one week. Then, on May 29th, 9 days after vaccination, he got fever to 102, chills, fatigue, itchy vesicular whole body rash, headaches and bodyaches, such that, had he been working, he would have missed work for one week. He was seen, and put on Valacyclovir 1 gram tid * 1 week for probable recurrent varicella illness. Viral PCR was positive for VZV. He recovered over the course of 7 days.
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| 56 | 2021-01-02 | weakness | Fatigue, lightheadedness, Fever (99.9-100.1), nausea and weakness. |
| 56 | 2021-01-03 | flushing | flushing, HTN, HA |
| 56 | 2021-01-03 | flushing | HA, flushing, HTN |
| 56 | 2021-01-06 | feeling cold | Feels very cold like ice on left arm |
| 56 | 2021-01-06 | feeling hot, pain in extremity |
At 01:30, 1/7/21, I developed Extreme chills, then body became hot but temperature was normal, At ar...
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At 01:30, 1/7/21, I developed Extreme chills, then body became hot but temperature was normal, At around 02:30, my whole body ached with a sharp pain just above my right wrist and a sharp pain at the ball of my right foot. It's 07:05 right now and still have body aches, pain in right foot and right wrist.
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| 56 | 2021-01-06 | pain in extremity |
positive COVID test; positive COVID test; fever; chills; sore throat; cough; nasal congestion; runny...
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positive COVID test; positive COVID test; fever; chills; sore throat; cough; nasal congestion; runny nose; little diarrhea; tiny bit of shortness of breath; Caller received the COVID-19 vaccine on 17Dec2020 and is scheduled to take the second dose on 5Jan2021.; Caller received the COVID-19 vaccine on 17Dec2020 and is scheduled to take the second dose on 5Jan2021.; sore arm; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect via a contactable physician (patient himself). A 56-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EH9899), via intramuscular route on 17Dec2020 at single dose (dose 1, left deltoid) for COVID-19 immunization. The patient medical history included non-smoker. Concomitant medications were reported as none. The patient was scheduled to take the second dose on 05Jan2021, also reported as 08Jan2021. The patient experienced sore arm for 24 hours afterwards on Dec2020. Patient experienced mild COVID symptoms such as fever, chills, sore throat, cough, nasal congestion, runny nose, little diarrhea, and tiny bit of shortness of breath on 24Dec2020, but stated he was better now. The patient was positive in the COVID test on 28Dec2020. He wanted to know if it was normal to get COVID after getting the vaccine and if he should get the booster shot if he gets better. He commented that testing positive for COVID was medically concerning. The patient did not require supplemental oxygen (including high flow ECMO) or receive a mechanical ventilation. Treatment included over the counter medication. No additional testing was done. The patient was not hospitalized. Outcome of the event sore arm was unknown; cough was not recovered; fever, chills, sore throat, nasal congestion, runny nose, little diarrhea, tiny bit of shortness of breath was recovering. No follow-up attempts are needed. Information about lot/batch number was already obtained. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 virus test positive cannot be totally excluded. The case will be reassessed if additional information becomes available.
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| 56 | 2021-01-07 | weakness |
fever 103.5; Chills; achy; has no energy; This is a spontaneous report from a contactable consumer (...
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fever 103.5; Chills; achy; has no energy; This is a spontaneous report from a contactable consumer (patient's wife). A 56-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EK9231), intramuscular (right deltoid) on 30Dec2020 0900, at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient has been in bed since 30Dec2020. The patient was achy, has no energy, and has chills on 30Dec2020. Patient also has a fever with temperature of 103.5 on 31Dec2020. Reporter asked if this was normal. Event outcome for achy and chills was recovered on 31Dec2020, not recovered for has no energy and unknown for fever 103.5.
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| 56 | 2021-01-07 | pain in extremity |
Headache sore arm, chills Narrative; 12/18 0100 AM woke up with a sore arm. Went back to sleep then...
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Headache sore arm, chills Narrative; 12/18 0100 AM woke up with a sore arm. Went back to sleep then woke up in the morning with ongoing sore arm, chills, and headache. He took 400 mg ibuprofen. All symptoms resolved by mid-afternoon on 12/18.
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| 56 | 2021-01-07 | pain in extremity | body ache arm sore chest pain |
| 56 | 2021-01-08 | pain in extremity |
Headache Left Arm soreness Narrative: Patient developed arm soreness at injection site and headache...
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Headache Left Arm soreness Narrative: Patient developed arm soreness at injection site and headache following vaccine administration. Resolved as of 1/2/21.
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| 56 | 2021-01-09 | pain in extremity | I had fever, chills, arm pain and swelling |
| 56 | 2021-01-10 | pain in extremity |
Arm soreness, severe muscle and joint pain, low grade fever, fatigue Treatment: Tylenol/ Motrin Outc...
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Arm soreness, severe muscle and joint pain, low grade fever, fatigue Treatment: Tylenol/ Motrin Outcome: symptoms better after 48 hours
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| 56 | 2021-01-10 | tremor | shaking chills fever |
| 56 | 2021-01-12 | numbness and pain in extremities |
neuropathy; pain; nausea; fatigue; bone, muscle, stomach pain; bone, muscle, stomach pain; bone, mus...
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neuropathy; pain; nausea; fatigue; bone, muscle, stomach pain; bone, muscle, stomach pain; bone, muscle, stomach pain; flare; increase in joint pain from his baseline; This is a spontaneous report from a Pfizer sponsored program Accredo Xeljanz Program. A contactable nurse and contactable consumer (patient) reported that a 56-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 18Dec2020 at a single dose for COVID-19 immunization and tofacitinib citrate (XELJANZ XR), orally from 02Oct2020 at 11 mg, daily for rheumatoid arthritis. The patient's medical history and concomitant medications were not reported. On 19Dec2020, the patient experienced neuropathy, pain, nausea, fatigue, bone, muscle, stomach pain and flare. In Dec2020, the patient experienced increase in joint pain from his baseline. The physician was aware. The patient was placed on unspecified steroids for the events, neuropathy, pain, nausea, fatigue, bone, muscle, stomach pain and flare which minimized symptoms. While weaning off steroids, the severity of symptoms returned. The patient was instructed by the doctor to stop taking tofacitinib citrate which was stopped on 29Dec2020. The action taken in response to the events for BNT162B2 was not applicable and for tofacitinib citrate was permanently withdrawn on 29Dec2020. The patient reported slight improvement after stopping tofacitinib citrate. The outcome of neuropathy, pain, nausea, fatigue, bone, muscle, stomach pain and flare was recovering and of increase in joint pain from his baseline was unknown. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: Based on the information available, the reported events are most likely due to patient underlying contributory factors and unlikely that it is related to the suspect product. However due to temporal association with the vaccine, a possible contributory role of vaccine cannot be ruled out. Case will be reevaluated based on additional information during the follow-up. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate.
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| 56 | 2021-01-12 | tenderness |
01/11/2021: 0901 assoc felt light headed b/p 139/96. felt well enough to leave site, no intervention...
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01/11/2021: 0901 assoc felt light headed b/p 139/96. felt well enough to leave site, no intervention. 01/13/2021: 0923 pt went to ED for reaction to vaccine. left supraclavicular node swelling extending up neck with erythema, tenderness. was seen in ED
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| 56 | 2021-01-13 | migraine |
H/A chills, fever, malaise, then migraines. Then 1-2 migraine H/A every day. No H/A for the past 3...
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H/A chills, fever, malaise, then migraines. Then 1-2 migraine H/A every day. No H/A for the past 36 hours. Went to see pcp.
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| 56 | 2021-01-13 | unresponsive to stimuli |
Cardiac arrest within 1 hour Patient had the second vaccine approximately 2 pm on Tuesday Jan 12t...
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Cardiac arrest within 1 hour Patient had the second vaccine approximately 2 pm on Tuesday Jan 12th He works at the extended care community and was in good health that morning with no complaints. He waited 10-15 minutes at the vaccine admin site and then told them he felt fine and was ready to get back to work. He then was found unresponsive at 3 pm within an hour of the 2nd vaccine. EMS called immediately worked on him 30 minutes in field then 30 minutes at ER was able to put him on life support yet deemed Brain dead 1-14-21 and pronounced dead an hour or so later
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| 56 | 2021-01-14 | pain in extremity |
Headache, Myalgia, heavy head pressure, chills and body aches; today dizziness and arm soreness Narr...
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Headache, Myalgia, heavy head pressure, chills and body aches; today dizziness and arm soreness Narrative:
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| 56 | 2021-01-17 | numbness | After 4 |
| 56 | 2021-01-19 | pain in extremity | Very sore left arm. Feels like someone hit it with a pipe. |
| 56 | 2021-01-20 | weakness | Onset of symptoms on 12 January, including weakness, fatigue, headache, muscle and joint stiffness. |
| 56 | 2021-01-20 | pain in extremity, tremor |
Felt brain fatigue; Felt very hungry before dinner; On 07Jan, after breakfast I suddenly felt tired,...
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Felt brain fatigue; Felt very hungry before dinner; On 07Jan, after breakfast I suddenly felt tired, so took a nap; During the whole day I took three naps; Had sore arm; Between 15-30 min after injection, I felt light arrhythmia twice and I tried to do deeper breath to control it. About 1.5 hours after injection, in between my pull-up exercises I felt light arrhythmia; his legs were shaking which had never happened before; This is a spontaneous report from a contactable consumer reporting for himself. A 56-years-old male patient received the first dose of bnt162b2 (BNT162B2; Lot # EL0140) vaccine , in the right arm on 05Jan2021 16:00 at single dose for Covid-19 immunisation . The patient medical history and concomitant medications were not reported. The patient experienced light arrhythmia on 05Jan2021 16:30 with outcome of recovered , his legs were shaking which had never happened before on 05Jan2021 with outcome of unknown, had sore arm on 06Jan2021 with outcome of recovered; felt brain fatigue on 07Jan2021 with outcome of recovered , , felt very hungry before dinner on 07Jan2021 with outcome of recovered , on 07Jan, after breakfast felt tired, so took a nap on 07Jan2021 with outcome of recovered , during the whole day i took three naps on 07Jan2021 with outcome of recovered. Course of the event: Between 15-30 min after injection, the patient felt light arrhythmia twice and tried to do deeper breath to control it. About 1.5 hours after injection, in between his pull-up exercises he felt light arrhythmia 2-3 times, and after doing the third set of pull-ups his legs were shaking which had never happened before. Next morning the patient woke up a couple hours later than his normal time. Noting that the night before he went to bed one hour earlier for no reason. When semi-waking up, he had a strong arrhythmia, followed by a couple more light ones. In the past arrhythmia did occur to him when he was very stressed or very tired, but had not have it for a few years. The patient had sore arm but tolerable. On 07Jan2021, after breakfast the patient suddenly felt tired, so took a nap. During the whole day he took three naps, which he had never done before. No arrhythmia though. The patient felt brain fatigue, but physically no problem. He felt very hungry before dinner, same as the day before, but not in other days.
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| 56 | 2021-01-21 | burning sensation |
Burning sensation, difficult to swallow, dizziness, redness in the chest, deep pain in the puncture ...
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Burning sensation, difficult to swallow, dizziness, redness in the chest, deep pain in the puncture area, iron flavor,
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| 56 | 2021-01-21 | cold sweat, tingling |
Pt received his first dose of Pfizer Covid vaccine today and after sitting for approximately 15 min....
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Pt received his first dose of Pfizer Covid vaccine today and after sitting for approximately 15 min. He was observed getting up from his chair and appeared to sway. Immediately went to pt to assess and asked how he was feeling. Pt states "feel a little dizzy". When asked if experiencing any other symptoms describes "my left arm is tingling". Pt denies any difficulty breathing or other symptoms. Pt did not want to try anything to drink. 1557: BP= 158/80 and Apical HR=80-82/min and regular. Resp. Rate 16/min. Pt began feeling dizzy while sitting so had another nurse assist to try to get to the floor and pt unable to stand or scoot. Had medical emergency team called. Able to get pt down to the floor with further assistance of two nurses. Pt alert and oriented the entire time. Pt able to move all extremities including the left arm which continues to feel tingling sensation. Pt is feels clammy while on the floor. BP: 140/100, HR 82/min. Med team arrived and decision made to transport to the ED. Pt lifted to gurney by team and transported. Accompanied pt. and contacted his wife to notify of pt. situation. She was at doctor appointment and will arrive in approximately 30 minutes. Report given during transport and on arrival to ED. Pt remained alert and oriented throughout episode. Pt was given IV Benadryl in the ED along with a liter of normal saline. Pt discharged after approximately 2 hours.
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| 56 | 2021-01-24 | numbness and pain in extremities |
My autoimmune disorder went into overdrive and stayed there. I had joint pain and swelling, severe n...
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My autoimmune disorder went into overdrive and stayed there. I had joint pain and swelling, severe neuropathy, muscle pain, extreme fatigue and nausea that seems to never end. I still feel nauseated three hours after eating.
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| 56 | 2021-01-25 | feeling cold |
I did not experience any adverse symptoms with the first dose of Pfizer-BioNTech vaccine with the ex...
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I did not experience any adverse symptoms with the first dose of Pfizer-BioNTech vaccine with the exception of injection site pain after the first dose that began on day 2 through day 5 or for 3 days. The first Pfizer-BioNTech dose was received on December 30, 2020, LOT EK5730. I would rate the pain as a 5 out of 10 on VAS on 12/31/20. Please note that I completed the same pretreatment protocol 1.5 hours prior to dosing with Pfizer-BioNTech of Diphenhydramine 25 mg plus Pepcid 20 mg for both COVID-19 doses. I elected to complete a self-administered pretreatment protocol due to a shellfish allergy and literature reports of anaphylaxis with COVID-19 mRNA vaccines in food allergy recipients. I did not experience any adverse symptoms on Saturday afternoon after receiving the second dose of the Pfizer-BioNTech vaccine at 4:45pm on 1/23/21. On Sunday morning 1/24/21, I awoke feeling "cold." I dressed warmly, but the feeling progressed to chills by 3pm. Malaise ensued around 1pm. I also experienced injection site pain on the morning of 1/24/21 beginning at 7am. The pain lasted until 1/25/21. I would rate the pain as a 5 out of 10 on VAS ON 1/24/21. I began to feel uncomfortable with malaise and chills at 6:15pm on 1/24/21 and self-administered one dose of OTC Aleve, Naproxen sodium 220mg plus one dose of Benadryl 25 mg. I began to feel better by 9pm on 1/24/21. I awoke on 1/25/21 without any symptoms or discomfort with the exception of some injection site pain (2 out of 10 on VAS). I have been asymptomatic since 1/26/21.
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| 56 | 2021-01-26 | night sweats |
4-6 HRS post injection loose stool. 8-12 hrs fatigue, body aches. 12-22 hrs flu like body aches, no ...
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4-6 HRS post injection loose stool. 8-12 hrs fatigue, body aches. 12-22 hrs flu like body aches, no sleep, comfort at all. 36-48 hrs after, fever > 100 F. Slept 12 hrs straight, woke up soaking wet, 49 hrs after, Fine..... shoveiing snow
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| 56 | 2021-02-01 | tremor |
FOLLOWING THE Pfizer BioNTech COVID-19 Vaccine EUA, EVENTS: DIAPHORESIS AND SHAKINESS STARTED BY 095...
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FOLLOWING THE Pfizer BioNTech COVID-19 Vaccine EUA, EVENTS: DIAPHORESIS AND SHAKINESS STARTED BY 0953 AM ON 02/02/2021 AND LASTED 15 MINUTES. HEART PALPITATION AND TACHICARDIA STARTED BY 0953 AM ON 02/02/21 AND ENDED AROUND 1025 AM INTERVENTIONS: RELAXATION OUTCOMES: DIAPHORESIS AND SHAKINESS ENDED BY 10:18 HEART PALPITATION AND TACHICARDIA ENDED AROUND 1025 AM PT NOTIFIED TO FOLLOW-UP WITH PCP IF NEW SYMPTOMS OR SYMPTOMS WORSEN
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| 56 | 2021-02-03 | weakness |
Uveitis (underlying condition occurring once every 2-3 years, I was NOT in a flare up at the time of...
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Uveitis (underlying condition occurring once every 2-3 years, I was NOT in a flare up at the time of the injection), and mouth ulcers (underlying condition occurring 2-3 times a year, I was NOT in a flare up at the time of the injection). For the Uveitis I went to my eye doctor and started a prednisolone regimen and am still on it. I received the 2nd does (lot EL9264) yesterday on 3 Feb at 09:00am. The mouth ulcers were treated with oral medication-Valtrex. 2nd dose does not seem to have aggravated the above noted reactions. Other symptoms common to the injection are occurring but seem more intense after the 2nd dose (aches, low energy, some minor coughing)
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| 56 | 2021-02-03 | numbness, tingling |
Lightheaded, dizzy for 4 hours; Toes, fingers and lips numb and tingly for 2 hours; Toes, fingers an...
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Lightheaded, dizzy for 4 hours; Toes, fingers and lips numb and tingly for 2 hours; Toes, fingers and lips numb and tingly for 2 hours; Toes, fingers and lips numb and tingly for 2 hours; Toes, fingers and lips numb and tingly for 2 hours; This is a spontaneous report received from a contactable physician (who is also the patient). A 56-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247, expiry date: unknown), via an unspecified route of administration in the left arm, on 19Jan2021 13:30, at single dose, for COVID-19 immunization, in the hospital. Medical history included asthma and environmental allergies. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. The patient did not have other vaccine in four weeks. Concomitant medications were unspecified (had other unspecified medications in two weeks). Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142, expiry date unknown), via an unspecified route of administration in the left arm, on 31Dec2020 13:30, for COVID-19 immunization. The patient was lightheaded, dizzy for 4 hours and experienced toes, fingers and lips numb and tingly for 2 hours, all on 19Jan2021 16:45. The events resulted in emergency room/department or urgent care visit. No treatment was provided. The patient recovered from dizzy for 4 hours on 19Jan2021 20:45 and from toes, fingers and lips numb and tingly for 2 hours on 19Jan2021 18:45.
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| 56 | 2021-02-03 | tingling |
Right Leg tingling; Strange Feeling; This is a spontaneous report from a contactable consumer (patie...
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Right Leg tingling; Strange Feeling; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received BNT162B2 via an unspecified route of administration on 20Jan2021 10:00 AM at a single dose as COVID vaccine. There were no medical history and no concomitant medications (no other vaccine in four weeks and no other medications in two weeks). The patient had no known allergies. The patient experienced right leg tingling and strange feeling on unspecified dates. Treatment was not received for the events. He had no COVID prior to vaccination. He did not have COVID tested post vaccination. The outcome of the events was unknown. Information on the lot/batch number has been requested.
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| 56 | 2021-02-06 | pain in extremity |
Pain on left arm and chest, increase in arterial blood pressure and sugar. The employee clinic docto...
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Pain on left arm and chest, increase in arterial blood pressure and sugar. The employee clinic doctor told me it was not related to the vaccine and it could be inflammation and suggested to make an appointment with my cardiologist, I wanted to let you know what I experienced, I respect my health professional's opinion.
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| 56 | 2021-02-07 | cold sweat |
Blood pressure sky high; Severe vertigo; Nausea; Vomiting; Cold sweats; This is a spontaneous report...
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Blood pressure sky high; Severe vertigo; Nausea; Vomiting; Cold sweats; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ELO3249; Expiration date was not reported) on 20Jan2021 (12:00) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization at the workplace clinic. Medical history included watermelon allergy. Concomitant medications included celecoxib (CELEBREX), metoprolol tartrate, simvastatin and lisinopril. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ELO140; Expiration date was not reported) on the right arm on 30Dec2020 (when the patient was 56 years old) for COVID-19 immunization. On 21Jan2021 (03:45), in the morning, the patient's blood pressure was sky high; had severe vertigo; nausea; vomiting; and cold sweats. The patient had resulted in the emergency room/department or urgent case for the reported events. The patient had received unspecified medications as treatment for the nausea and vertigo. The outcome of the events, 'blood pressure was sky high', 'severe vertigo', 'nausea', 'vomiting' and 'cold sweats', was recovering. The patient was not diagnosed with COVID-19 prior to vaccination, and had been tested for COVID-19 (nasal swab) post-vaccination which was negative on 21Jan2021.
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| 56 | 2021-02-11 | pain in extremity |
Pain on the upper arm. It lasted around 24 hours The lymph nodes at the neck also had pain and swoll...
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Pain on the upper arm. It lasted around 24 hours The lymph nodes at the neck also had pain and swollen the next day after shot. It disappeared after 24 hours
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| 56 | 2021-02-14 | pain in extremity |
had to close my eyes due to the faint feeling; palpitation; Fatigue; chills in the back of the head;...
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had to close my eyes due to the faint feeling; palpitation; Fatigue; chills in the back of the head; Arm soreness; felt a mild palpitation but not as strong as the strong one I experienced after the first injection/Arm soreness was much less than after the first dose/Fatigue was comparable; This is a spontaneous report from a contactable consumer (patient). A 56-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL3246), via an unspecified route of administration in right arm on 26Jan2021 12:30 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical Vaccine included received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL0140), via an unspecified route of administration in right arm on 05Jan2021 at single dose for COVID-19 immunization and experienced palpitation, Arm soreness and Fatigue. 30 min after injection, the patient felt a mild palpitation-stronger than any previous mild ones but not as strong as the strong one he experienced after the first injection, and he had to close his eyes due to the faint feeling. This was followed by a mild one 3 min later. In the next few days he had several additional mild to weak palpitations. The strong one that he experienced 12-14 hours after receiving the first dose did not show. Arm soreness was much less than after the first dose. Fatigue was comparable, and in third day still had to take a nap immediately after the breakfast. Additional nap was taken during the day-needed more but did not have time. The patient felt some chills in the back of the head some days but did not get "sick" at all. All events occurred on 26Jan2021 13:00. No treatment received for the events. The patient did not receive any other vaccines in four weeks. The patient had no COVID prior vaccination. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was resolved in Jan2021.
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| 56 | 2021-02-18 | pain in extremity |
Soreness at injection site and all of arm - within 6 hours through about 36 hours Fatigue - 6-8 hour...
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Soreness at injection site and all of arm - within 6 hours through about 36 hours Fatigue - 6-8 hours Body aches, headache, chills, fever - one week after for about 48 hours
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| 56 | 2021-02-19 | weakness |
Pain throughout the body and some weakness Headaches Pain at injection site on left arm Had symptom...
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Pain throughout the body and some weakness Headaches Pain at injection site on left arm Had symptoms for two full days and treated with ibuprofen and or Tylenol
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| 56 | 2021-02-19 | tremor |
Severe Chills, uncontrolled shaking, for 2 hours, moderate fever 102.4, moderate muscle aches. Each ...
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Severe Chills, uncontrolled shaking, for 2 hours, moderate fever 102.4, moderate muscle aches. Each for 2 nights.
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| 56 | 2021-02-21 | numbness |
Approximately 12 hours after vaccination, woke up with numbness and tingling on complete right side ...
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Approximately 12 hours after vaccination, woke up with numbness and tingling on complete right side of my body. Reaction has not gone away since the vaccination, 3 weeks ago. The reaction has decreased butt still exist up and down my right arm and hand, along on the right side of stomach.
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| 56 | 2021-02-22 | tremor |
Tiredness, shaky feeling, chills, mild lymph node swelling, low grade fever(<=99degreesF), loss of a...
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Tiredness, shaky feeling, chills, mild lymph node swelling, low grade fever(<=99degreesF), loss of appetite. Treated w/ bed rest, water, and ibuprofen. Lasted three days after shot. Fourth day, no fever, no swollen glands, and appetite returning.
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| 56 | 2021-02-25 | burning sensation |
upper lip edema; roof of mouth irritation and burning; gum irritation and burning; nose irritation a...
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upper lip edema; roof of mouth irritation and burning; gum irritation and burning; nose irritation and burning TRX: Benadryl 25mg X1 then Benadryl 50mg TID x 5 days Patient improved
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| 56 | 2021-03-01 | bell's palsy, face paralysis |
Bell Palsy, Rt face weakness, Adult. Treating with Valacyclovir HCL 1gm tab #21/21, 1 tab for 7 day...
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Bell Palsy, Rt face weakness, Adult. Treating with Valacyclovir HCL 1gm tab #21/21, 1 tab for 7 days; and Prednisone 20mg tab, 3 tabs per day for 7 days.
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| 56 | 2021-03-02 | pain in extremity |
Mild palpitation; faint feeling; Arm soreness; This is a spontaneous report from a contactable consu...
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Mild palpitation; faint feeling; Arm soreness; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received first single dose of BNT162B2 (Pfizer, lot number: EL0140, exp date not reported), via an unspecified route of administration (vaccine location: right arm) on 05Jan2021 for COVID-19 immunization. Facility type vaccine: Hospital. The patient's medical history and concomitant medications were not reported. The patient had no Covid prior to vaccination. On 05Jan2021, 30 min after injection, felt a mild palpitation-stronger than any previous mild ones but not as strong as the strong one he experienced after the first injection, and he had to close his eyes due to the faint feeling. This was followed by a mild one 3 min later. In the next few days, he had several additional mild to weak palpitations. The strong one that he experienced was 12-14 hours after receiving the first dose, did not show. The patient also experienced arm soreness after the first dose (Jan2021). The patient was not Covid tested post vaccination. The patient recovered from the events on an unspecified date in Jan2021.
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| 56 | 2021-03-04 | tingling |
On the night of vaccine I had a fever up to 101 degrees, aches and fatigue into the next day. Two d...
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On the night of vaccine I had a fever up to 101 degrees, aches and fatigue into the next day. Two days later I started having diffuse sporadic and intermittent tingling on various parts of my body. That lasted about 2 days in its greatest severity. On day 6 post vaccine, I was walking in an airport and developed chest pain, tachycardia, and shortness of breath out of proportion to my level of exertion. This chest pain, shortness of breath and tachycardia with minimal exertion (a flight of stairs. A walk to the end of driveway.) has persisted since then. A cardiac w/u with Echo and treadmill stress ECHO were negative. I also have intermittent fatigue, headaches, and a mild "brain fog."
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| 56 | 2021-03-08 | weakness |
Extreme nausea, headache, weakness, mentally unawares, dizziness, and at the gym on a cardio machine...
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Extreme nausea, headache, weakness, mentally unawares, dizziness, and at the gym on a cardio machine, couldn't get enough oxygen circulation in the lungs, swollen inner ear in both ears, swollen hands, just overall feeling of fatigue.
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| 56 | 2021-03-10 | pain in extremity |
Starting 24 hours after vaccination, had mild influenza like illness-bodyaches, fatigue, cough. No m...
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Starting 24 hours after vaccination, had mild influenza like illness-bodyaches, fatigue, cough. No measured fever or chills. Left sided tender but non painful axillary lymphadenopathy. Treated symptomatically with ibuprofen. Symptoms resolved within 36 hours. Left arm soreness resolved within approx 72 hours post vaccine; no injection site redness or swelling.
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| 56 | 2021-03-13 | weakness |
First injection - only a sore right deltoid (injection site). Fairly intense but only lasted 24 hou...
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First injection - only a sore right deltoid (injection site). Fairly intense but only lasted 24 hours and easily alleviated by Tylenol. Second injection - Ringing in my ears - noticeable starting about 9pm the day of the second injection (3/11/21) and it's still going strong. Intensity of ringing has remained constant to date unfortunately. Headache was minor and on & off starting the night of the injection date and appear to still encounter them but intensity has been low. Taken Tylenol to alleviate symptom with success. Soreness at injection site - less intense on second shot than first but it lasted about 48 hours. The Tylenol I took for the headache seemed to help with the arm pain. On the day after the injection, my right latissimus dorsi (same side as shot) became sore but only for about 24 hours. Tiredness - didn't feel the exhaustion until about 9pm on the day of the injection. Exhaustion/tiredness set in more than expected so very low activity the day after and went to bed several hours earlier than normal. Still feeling tired but emerging from that as i'm starting to feel more energy come back.
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| 56 | 2021-03-14 | feeling hot |
At 1005 Patient, a 56 yo Male was sitting in a 15 minute observation after receiving a first dose Pf...
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At 1005 Patient, a 56 yo Male was sitting in a 15 minute observation after receiving a first dose Pfizer (Lot EP7534 Expiring 07/31/2021) five minutes prior. Patient reported feeling lightheaded and feeling a "heart warmth". Client reported past medical history of Neuropathy, Mechanical mitral valve replacement, aortic valve repair, hyperlipidemia, coronary artery disease, hypertension, DMII, dyspnea, obesity, depression and pulmonary hypertension. Client denied any allergies to medication, food or seasonal allergies. Client stated he last ate at 1030pm on 3/14/2021. Denied having any food, drink or diabetic medication this morning. Client rated the severity of heart warmth as a 2/10. Client stated warmth in his heart was similar to the sensation he had when doing a heart stress test. Client denied chest pain, shortness or breath, blurry vision, dizziness, headache, nausea, vomiting, diarrhea, recent illness or lifestyle changes. At 1018am client had water and ate a fruit bar he had. At 1022am client stated the warm sensation had diminished and he felt better after eating and drinking. Client denied dizziness, blurry vision and chest pain. Site offered to call 911 to have an ALS assessment. Client declined further evaluation and care. At 1045am Client was able to ambulate without assistance and had a steady gait as he left the observation site.
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| 56 | 2021-03-14 | tremor | Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium |
| 56 | 2021-03-15 | bell's palsy, facial paralysis |
Developed new onset unilateral facial drooping, difficulty with eyelid closure, loss of nasolabial f...
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Developed new onset unilateral facial drooping, difficulty with eyelid closure, loss of nasolabial fold, and loss of forehead furrow on 3/7/2021 diagnosed as Bell's palsy
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| 56 | 2021-03-17 | discomfort |
discomfort; did not sleep a wink last night; Nauseous; blood pressure elevated/139/94; heart rate el...
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discomfort; did not sleep a wink last night; Nauseous; blood pressure elevated/139/94; heart rate elevated/His heart rate is currently 139; This is a spontaneous report from a contactable consumer (patient). A 56 -year-old male patient received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL9264), intramuscular (on left arm) on 28Jan2021 12:30 (at the age of 56 -years-old), single dose for COVID-19 immunization. No relevant medical history. The patient's concomitant medications were not reported. Patient is calling about the first dose of the Pfizer covid19 vaccine which he received on Thursday. Yesterday, he started getting nauseous, it is terrible and very strong. The nausea has been continuous since yesterday. His blood pressure and heart rate is pretty elevated. Declines any treatment. The nausea was bad yesterday and stayed bad, he did not sleep a wink last night. His last blood pressure taken about 10 minutes ago was 139/94. His blood pressure is normally 125 over 65 or 70. His heart rate is currently 139. His heart rate and blood pressure became elevated yesterday. States it might have to do with how much discomfort he is in. When querying other medications and medical conditions, he reports nothing out of the ordinary. The outcome of the events sleep disorder and discomfort was unknown, other events was not recovered. No Prior Vaccinations (within 4 weeks).No AE(s) following prior vaccinations.
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| 56 | 2021-03-17 | tingling |
pt. complain of numbness and tingling of his left hand from the site of the vaccination to his finge...
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pt. complain of numbness and tingling of his left hand from the site of the vaccination to his fingers. They symptoms were resolved and the patient went home.
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| 56 | 2021-03-18 | flushing | A little,flush around neck and ears. But almost not noticeable. |
| 56 | 2021-03-18 | numbness |
1:45 presented himself in observation w/ c/o numbness in lt.arm. Skin W/D, capillary refill left ha...
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1:45 presented himself in observation w/ c/o numbness in lt.arm. Skin W/D, capillary refill left hand quick. No other symptoms. Second observation. Very talkative, laughing, telling jokes, w/ no further c/o lt.arm numbness. Advised if reoccurs seek medical attention.
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| 56 | 2021-03-18 | pain in extremity | headache, arm soreness |
| 56 | 2021-03-19 | pain in extremity |
sore arm day after, which cleared. (I expected this) However, a couple days after vaccine, I starte...
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sore arm day after, which cleared. (I expected this) However, a couple days after vaccine, I started developing hive like rash on right side. At first I thought it might be scratches/irritation from sharp edges on a torn leather sofa, but more red welts appeared in unrelated locations: chest and back. I have had childhood chickenpox, and have also considered stress as a possible trigger for shingles, but that seems remote to me.
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| 56 | 2021-03-21 | numbness |
48 hours after vaccination numbness in the facial area... including lips, left ear, forehead and che...
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48 hours after vaccination numbness in the facial area... including lips, left ear, forehead and cheek. Not severe and no visual effects to date.
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| 56 | 2021-03-22 | bell's palsy | Bells palsy R side |
| 56 | 2021-03-23 | tingling |
Uncomfortable aching in right shoulder and elbow for 3 weeks, continued tingling in 3 middle fingers...
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Uncomfortable aching in right shoulder and elbow for 3 weeks, continued tingling in 3 middle fingers on right hand at times.
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| 56 | 2021-03-25 | burning sensation | Burning sensation of bilateral hands. dryness of mouth/throat |
| 56 | 2021-03-25 | burning sensation | no visible redness or other sign but softball sized burning sensation of skin on upper thigh. |
| 56 | 2021-03-25 | feeling hot |
It began with a headache around 2 am, March 26, 2021. Around 8:30 am I began to experience nausea a...
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It began with a headache around 2 am, March 26, 2021. Around 8:30 am I began to experience nausea and fatigue. At 3:30 pm I vomited one time. Since 8:30 am I have slept about six hours. I also felt hot on and off during this time, but I have checked my temperature 3 times and it was normal all three times.
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| 56 | 2021-03-25 | unresponsive to stimuli |
Patient here for COVID 19 vaccine Arrived to drive through as passenger in car. He did let RN know...
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Patient here for COVID 19 vaccine Arrived to drive through as passenger in car. He did let RN know before vaccine he has felt faint and has had syncopal episodes after injections or blood draws. Immediately after injection he had a loss of conciseness. Lasting approximately 1min. Partner states this was a normal reaction. He then had a second episode lasting longer than first. Partner states this is not a normal reaction for him. He was not responding to voice or touch after approximately 1-2 mins he was alert and responsesive to person, place and situation. RN stayed with Patient as he remained in car. 911 called to evaluate RN gave report and hand of to EMS. per RN
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| 56 | 2021-03-26 | weakness | Shoulder pain, loss of range of motion, weakness |
| 56 | 2021-03-27 | weakness | Aches, no energy, fatigue, spotty rash, itchy |
| 56 | 2021-03-28 | discomfort, tenderness, facial paralysis |
Per MD note: Notably patient received Pfizer COVID 19 vaccine on March 12 th. He was doing well but...
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Per MD note: Notably patient received Pfizer COVID 19 vaccine on March 12 th. He was doing well but then 3/24/21 patient noted his right eye was feeling "funny" and the next day or 2 it continued and then was hard to close eye on its own. In the last 1-2 days he is having a right facial droop and cannot hold his mouth closed with puffing out cheeks. Separately he also has tenderness like a bruised area just anterior to the right ear and describes a fullness/swelling of the tissue there and more anteriorly on the cheek. He does not recall similar sensation with his prior Bell's Palsy which was on the left side 2 years ago. He denies other symptoms , with out fever or chills. No other suggestion of sicknesses.
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| 56 | 2021-03-28 | cold extremities |
cold shooting through extremities, torso going to jelly, heat on back of neck. Would come in waves ...
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cold shooting through extremities, torso going to jelly, heat on back of neck. Would come in waves every 5-10 mins. Started about 30 mins after injection. Hospital treated with benedryl, and high dose anti-inflammatory. Observed for 3 hours. Symptoms quit.
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| 56 | 2021-03-31 | tingling, tremor, numbness |
Symptoms starting coming on about 20 Hours after the shot. Sever Chills and shaking for about 2 hour...
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Symptoms starting coming on about 20 Hours after the shot. Sever Chills and shaking for about 2 hours. Top of head numb and tingling . Severe Fatigue. Sore across the shoulders. Slight Blurred Vision. Fever of 100.5 Usually run around 97.1 on a normal day. Body ache to the point walk very slowly. Lose of appetite and only had about 10 oz of water during the adverse event time. With Tylenol and resting through the evening by 5:00 AM the next morning I was close to full recovery. Top of Head was still still slightly numb. 24 hours after the onset of the event I am back to normal.
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| 56 | 2021-04-01 | feeling cold |
Client called for assistance feeling a cold sensation down his throat. Firefighters first responded....
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Client called for assistance feeling a cold sensation down his throat. Firefighters first responded. Client stated he was feeling good. Client was released to his home at 4:00pm.
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| 56 | 2021-04-01 | numbness | numbness in cheeks, dry throat. Evaluated by EMS-Cleared |
| 56 | 2021-04-01 | pain in extremity, numbness, tingling |
Initial shoulder soreness developed into severe shoulder pain that continues after 4 week. Stinging ...
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Initial shoulder soreness developed into severe shoulder pain that continues after 4 week. Stinging and constant pain beneath scapula, running through armpit to fingers. Index finger is numb, middle finger and thumb tingle. Based on my web searchers in sounds like SIVAR.
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| 56 | 2021-04-01 | pain in extremity | Nausea, Diarrhea, Body Aches, Arm pain, Fatigue,Feel Unwell,Light Headed |
| 56 | 2021-04-02 | flushing |
Flushing/sweating, dizziness, chest tightness. BP 162/110 (pulse 76). Final BP 153/104 (pulse 80). O...
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Flushing/sweating, dizziness, chest tightness. BP 162/110 (pulse 76). Final BP 153/104 (pulse 80). O2 sats 99%-100%. Apple juice and water given.
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| 56 | 2021-04-03 | cold sweat |
At 8:35pm on 3/30, sudden onset severe vertigo while lying down - lasting only a minute - followed b...
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At 8:35pm on 3/30, sudden onset severe vertigo while lying down - lasting only a minute - followed by severe nausea and cold sweat. Couldn't open eyes or move head for fear of repeating episode. A few hours later, a repeat episode lasted a few minutes and triggered vomiting. Around 7am the next morning, a third episode violent enough to trigger vomiting again. The severe nausea and headache lasted around 12 hours, but the mild nausea and severe headache lasted 48 hours. At 5 days after vaccination, still feel lightly dizzy with a sense of confusion or fogginess.
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| 56 | 2021-04-03 | numbness |
On Thursday April 1, 10 days after the vaccine (1st shot) I began to experience itch hives all over...
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On Thursday April 1, 10 days after the vaccine (1st shot) I began to experience itch hives all over my body. I took Benadryl at 2 pm and 8 pm to relieve the symptoms. It helped. At 7 am, morning of Friday April 2, I took Claritin to relieve symptoms but it was not effective. At 9:15 am, morning of Friday April 2, my lips and cheeks began to go numb, and it felt as if my throat and tongue were swelling. At 9:30 am. I checked in to the ER. They monitored my condition and indicated my blood pressure and oxygen levels were normal. At approximately 10:15 am, my mouth began to feel normal again. While at the ER, the doctor checked out my hives and gave me Prednisone. She also gave me a prescription for 4 days of Prednisone, 50 mg tablets, and advised to continue taking Benadryl to relieve symptoms. I have taken Prednisone once a day for past couple days and Benadryl 3 times a day. Hives are still present today Sunday April 4, 2021 but milder than previous days.[Not certain if this is important, but on day 3 and 4 after the vaccine, I reported dizziness on mobile app check-in. The dizziness went away by day 5. I had no other symptoms appear until day 10 reported here.
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| 56 | 2021-04-04 | facial pain, bell's palsy, facial paralysis |
Participant reported waking up the next morning after his Pfizer vaccine with right facial paralysis...
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Participant reported waking up the next morning after his Pfizer vaccine with right facial paralysis and severe facial pain. Pt went to his primary care physician and was diagnosed with bell's palsy and instructed not to receive second dose of Pfizer.
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| 56 | 2021-04-04 | pain in extremity |
I got home at 5 am from getting the shot, and laid down, I woke up at 9 am for a 10 am meeting with ...
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I got home at 5 am from getting the shot, and laid down, I woke up at 9 am for a 10 am meeting with left arm soreness at the site of the injection. I then developed body chills, ackey sore muscles Back, chest, arms and a really nagging headache. I was very groggy. Saturday, I was a mess, I bundled up with an electric blanket to stay warm. I slept most of the day. The symptoms lasted until Sunday (Easter) around noon, when I started to feel normal again
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| 56 | 2021-04-05 | pain in extremity, muscle spasms |
He had the vaccine, and had some pain in his arm and a headache. He woke up Thursday morning 4/1/2...
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He had the vaccine, and had some pain in his arm and a headache. He woke up Thursday morning 4/1/21 with severe back pain, spasm, and not able to more. He did not have this pain before the vaccine. He did alternate between Ibuprofen and Tylenol for the pain and it did not help.
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| 56 | 2021-04-06 | numbness, tingling |
full body rash, worse on hands. itching, feeling of tingling and numbness. fluttering feeling in che...
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full body rash, worse on hands. itching, feeling of tingling and numbness. fluttering feeling in chest.
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| 56 | 2021-04-06 | muscle spasms |
After shot, started getting muscle spasms in entire body and muscle aches, bad headache, fever of 10...
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After shot, started getting muscle spasms in entire body and muscle aches, bad headache, fever of 100.8 . Started the same night as the vaccine was given, worse the next day.
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| 56 | 2021-04-06 | seizure |
Complex seizures; Explosive diarrhea; Profuse vomiting; Chills; sweats; This is a spontaneous report...
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Complex seizures; Explosive diarrhea; Profuse vomiting; Chills; sweats; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EN6207), via an unspecified route of administration in the left arm, on 22Mar2021 at 09:30 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food, or other products. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN) and atorvastatin (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced complex seizures, explosive diarrhea, profuse vomiting, chills, and sweats on 22Mar2021 at 19:00. All of the events required hospitalization from an unspecified date to an unspecified date for one day. The patient underwent lab tests and procedures which included nasal swab: negative on 22Mar2021. Therapeutic measures were taken as a result of all of the events, which included intravenous fluids. The clinical outcome of complex seizures, explosive diarrhea, profuse vomiting, chills, and sweats was recovered on an unspecified date. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 56 | 2021-04-07 | tremor, muscle spasms |
Autoimmune response involving all previous symptoms of PTLDS especially dizziness, multiple joint pa...
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Autoimmune response involving all previous symptoms of PTLDS especially dizziness, multiple joint pain especially spine, shoulders and hands along with uncomfortable stomach pain and severe headache. Treatment -water, some pepto, and 2 ibuprofen. Started previous evening with fatigue and hands, woke up around two AM with tremors and cramping, all symotoms worsening to the mid afternoon. Unable to stand or walk with confidence or safely hold objects
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| 56 | 2021-04-08 | pain in extremity |
double pneumonia; body aches/I started aching; headache; tired/fatigue/exhausted; I got the chills; ...
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double pneumonia; body aches/I started aching; headache; tired/fatigue/exhausted; I got the chills; my skin felt like it was sunburned; cough; fog; no appetite; sweating; my arm hurt/sore arm; he had a previous flu like symptoms after the shingles vaccine.; This is a spontaneous report from a contactable consumer (Patient). A 56-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- ER8727), via an unspecified route of administration in the left arm on 24Mar2021 at 10.30 (at the age of 56-years-old) as single dose for covid-19 immunisation. Medical history included hypertension diagnosed 20 years ago, blood cholesterol diagnosed about 7 years ago, Covid-19 in Dec2020 which hit him pretty hard, double pneumonia, he was wiped out, patient had a shingles vaccine a couple of years ago he had a fever and it felt like he had the flu, for about 48 hours he was wiped out. This happened with both doses of the shingles vaccine. Concomitant medication(s) included colecalciferol (VITAMIN D [COLECALCIFEROL]) and vitamin C (ascorbic acid) (VITAMIN C [ASCORBIC ACID]). On 24Mar2021 (Wednesday), patient experienced double pneumonia, body aches/i started aching, my arm hurt, headache, tired/fatigue/exhausted, i got the chills, my skin felt like it was sunburned, cough, fog, no appetite, sweating, sore arm, he had a previous flu like symptoms after the shingles vaccine. It was reported that all the same symptoms the patient had with COVID, the caller had after the vaccine. The next morning was much worse and through that next day. Patient describes his side effects like a mini Covid 19 reaction. The symptoms were very similar to the symptoms he had 4 days into his Covid-19 diagnosis. It was reported that on Friday (26Mar2021) he felt normal and was able to workout on Saturday (27Mar2021) as usual. The patient believes his antibodies are strong following his virus and then the 1st Pfizer vaccine dose. The patient doesn't think he had a fever, but he didn't have that with covid along with no loss of taste and smell. The patient was very grateful for the vaccine. Patient had no other vaccinations within 4 weeks prior vaccination. The patient underwent lab tests which included blood cholesterol and blood pressure whose results are reported as high on an unknown date. The outcome of the event double pneumonia was unknown, and for all other events it was recovered.
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| 56 | 2021-04-09 | weakness, pain in extremity |
Left arm pain for 48 hours; Weakness for 48 hours; Lightheadedness for 24 hours; This is a spontaneo...
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Left arm pain for 48 hours; Weakness for 48 hours; Lightheadedness for 24 hours; This is a spontaneous report from a contactable other hcp. A 56-years-old male patient received bnt162b2 (BNT162B2, Solution for injection, Lot Number: EN5318), dose 1 via an unspecified route of administration, administered in Arm Left on 04Feb2021 10:15 as SINGLE DOSE for an unspecified indication. Medical history included depression, bipolar i disorder, insomnia, hypercholesterolaemia from an unknown date. Concomitant medications included asa (ASA); atomoxetine hydrochloride (STRATTERA); escitalopram oxalate (LEXAPRO); gabapentin (NEURONTIN); trazodone. The patient experienced left arm pain for 48 hours (pain in extremity), weakness for 48 hours (asthenia), lightheadedness for 24 hours (dizziness) on 04Feb2021 at 12:00. Therapeutic measures were taken as a result of left arm pain for 48 hours (pain in extremity), weakness for 48 hours (asthenia), lightheadedness for 24 hours (dizziness), acetaminophen was provided. The action taken in response to the event(s) for bnt162b2 was not applicable. Outcome of the event lightheadedness was recovered on 05Feb2021 at 12:00 and event left arm pain and weakness was recovered on 06Feb2021 at 12:00. Follow-up attempts are completed. No further information is expected.
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| 56 | 2021-04-09 | weakness |
Heavy Vomiting headache being very weak next day very weak no energy very weak slight headache arm i...
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Heavy Vomiting headache being very weak next day very weak no energy very weak slight headache arm is very very sore swollen for injection was injected
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| 56 | 2021-04-09 | bell's palsy |
Bell's Palsy; administered in the left leg; This is a spontaneous report from a contactable consumer...
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Bell's Palsy; administered in the left leg; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8727, expiry date: unknown), via an unspecified route of administration, administered in the left leg, on 21Mar2021 09:45, as single dose, for COVID-19 immunization. The patient medical history was not reported. The patient did not have COVID-19 prior to vaccination. There were no concomitant medications (no other medications in two weeks). The patient did not receive other vaccines in four weeks. On 22Mar2021, the patient experienced Bell's palsy. This event required hospitalization for 2 days (unspecified dates). Treatment included steroids. The patient underwent COVID Nasal Swab and tested negative on 22Mar2021. The outcome of the event Bell's palsy was not recovered. Information on Lot/Batch number was available. Additional information has been requested.
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| 56 | 2021-04-10 | tingling |
pt reports that he developed paresthesia left side of face approximately 24 hours after receiving th...
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pt reports that he developed paresthesia left side of face approximately 24 hours after receiving the 2nd vaccine; very mild facial asymmetry; hx of bells palsy in past
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| 56 | 2021-04-11 | weakness |
40 hours after the second vaccine, I woke up and felt drained and exhausted with no energy. No other...
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40 hours after the second vaccine, I woke up and felt drained and exhausted with no energy. No other symptoms. I took a 4 hour nap and when I woke from the nap I felt perfectly fine and full of energy.
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| 56 | 2021-04-11 | weakness |
Woke up with tinnitus in right ear on 2/27/21, almost exactly 2 weeks after second vaccination shot ...
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Woke up with tinnitus in right ear on 2/27/21, almost exactly 2 weeks after second vaccination shot (Pfizer). Within days, fatigue and weakness set in with some sporadic joint and stomach pain. Symptoms persist today, six weeks later.
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| 56 | 2021-04-11 | numbness |
Date and time adverse event started: ringing of the ears 3-28-21, 4-5-21 numbness face 4/8-recomme...
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Date and time adverse event started: ringing of the ears 3-28-21, 4-5-21 numbness face 4/8-recommended he get seen by his pcp or local ER to r/o bells palsy or stroke like symptoms related to his reported numbness to unilateral side of his face. caller verbalized understanding. caller spoke with no slurr and was oriented X4 during the call
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| 56 | 2021-04-11 | pain in extremity |
Bruising around the are of shot administration, general fatigue with arm soreness and occasional min...
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Bruising around the are of shot administration, general fatigue with arm soreness and occasional minor throbbing.
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| 56 | 2021-04-12 | weakness | Severe, debilitating dizziness and weakness that lasted 48 hours. |
| 56 | 2021-04-12 | feeling cold, pain in extremity, numbness |
Developed chills, body aches and low grade fever starting at 5pm on 3/30 (more than 24 hrs after rec...
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Developed chills, body aches and low grade fever starting at 5pm on 3/30 (more than 24 hrs after receiving vaccine), fever topped out at 101.7 degrees, fever remained overnight, broke by 10am next day, chills remained for about another 24 hours. Likely unrelated, developed right knee, calf and foot pain and had numbness in 2 left foot inner toes, off and on for 3-4 days after fever broke. Took 2 Advil, pain completely disappeared by 2 days later. I have arthritis and have had 2 right/1 left knee surgeries, and the temperature rose right about the time the pain disappeared, but the cold has returned and no pain. Just odd, almost like a side effect of producing anti-bodies was excessive inflammation in parts of my body prone to inflammation. I get the flu vaccine every year, and I have flu-like symptoms (chills, aches, low-grade fever) for several days within 24 hrs every year.
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| 56 | 2021-04-12 | feeling hot |
I started having a severe headache, chills and I thought I had fever I was feeling hot but I did not...
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I started having a severe headache, chills and I thought I had fever I was feeling hot but I did not have fever, I had nausea , then after 3 hours of the above symptoms I vomited. From then I fully recover just I had light headache for a few hours.
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| 56 | 2021-04-13 | slurring, facial paralysis, tingling, numbness |
The adverse event was a small stroke which occurred after/during a severe headache . There was numbi...
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The adverse event was a small stroke which occurred after/during a severe headache . There was numbing/tingling and muscle contractions in my left hand followed my face drooping and slurred speech. It was never said that the stroke was caused by the vaccine. It may have been a factor though.
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| 56 | 2021-04-13 | numbness | Facial numbness. |
| 56 | 2021-04-13 | pain in extremity |
On the evening of the injection, he had fever of greater than 104 degrees with shaking chills. He ca...
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On the evening of the injection, he had fever of greater than 104 degrees with shaking chills. He called the Health Dept. because he feels that the shot was given into the shoulder joint. He describes pain in the shoulder joint at a level of 2-3 on a 10 point scale. By yesterday, his fever was down to ~99degrees. Today, he is feeling better, but his arm is still tender and he increased tenderness when he raises his elbow.
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| 56 | 2021-04-14 | numbness |
Site: Pain at Injection Site-Medium, Systemic: Numbness (specify: facial area, extremities)-Severe, ...
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Site: Pain at Injection Site-Medium, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Unable to Sleep-Medium, Additional Details: Patient reports experiencing numbness in both arms, has doctor's appt scheduled for further follow-up
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| 56 | 2021-04-14 | numbness |
After 20 minutes I lost feeling in the left side of my face. It also radiated down my left arm. It...
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After 20 minutes I lost feeling in the left side of my face. It also radiated down my left arm. It subsided after 7 hours and was gone after 18 hours. The following morning I woke to a sore back in an area I have had issues with. The pain progressed and has gotten worse over the past two months. I have gone from training for a triathlon to only being able to walk about one mile with pain. I am in pain 24 hours a day now.
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| 56 | 2021-04-14 | pain in extremity | Bilateral foot pain in ball of foot and toes, stiffness in the plantar fascia. |
| 56 | 2021-04-14 | pain in extremity |
Fatigue, diarrhea, joint pain, muscle weakness, pain in both hands, headache, neck pain. Fatigue on...
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Fatigue, diarrhea, joint pain, muscle weakness, pain in both hands, headache, neck pain. Fatigue onset 4/10/21, symptoms worsened 4/13/21.
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| 56 | 2021-04-14 | pain in extremity |
Very sore arm. Mild swelling. Very painful to move my arm. Especially painful moving upwards over my...
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Very sore arm. Mild swelling. Very painful to move my arm. Especially painful moving upwards over my head.
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| 56 | 2021-04-15 | weakness |
Patient complained of feeling weak and sweaty. No chest pain or shortness of breath or rash. Treatme...
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Patient complained of feeling weak and sweaty. No chest pain or shortness of breath or rash. Treatment- NO po water or juice given as patient is muslim and was fasting VS 203/138, HR 69, RR 12, Pulse Ox 99% EMS called for elevated BP and symptoms EMS arrived and repeated BP with manual cuff and BP was 137/86, accucheck normal and was released to go home Patient was obsed for one hour and DCed home
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| 56 | 2021-04-15 | pain in extremity, discomfort |
Patient presents to clinic for swollen left axillary lymph nodes. Patient states he had his 2nd COVI...
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Patient presents to clinic for swollen left axillary lymph nodes. Patient states he had his 2nd COVID-19 vaccine on 4/6/21 and he noticed the swelling on 4/9/21. Swelling is now staying the same. Denies pain but there is some discomfort. No change in deodorant. COVID vaccine received in left arm. Patient states intermittent pain of left forearm for the past two week. States an achy feeling. Pain will wake him up at night. States he normally has to turn or stretch arm to make it feel better. ED visit after 1st COVID vaccination- shortness of breath. He notices if he is taking a strenuous walk he will get short of breath. This has continued since his 1st COVID vaccination.
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| 56 | 2021-04-15 | pain in extremity |
Caller stated he had Pfizer first vaccine last Friday. Next day had arm pain and was tired. Then on ...
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Caller stated he had Pfizer first vaccine last Friday. Next day had arm pain and was tired. Then on Monday through Wednesday felt more fatigued with diarrhea. He stated feelin a bit better today.
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| 56 | 2021-04-16 | pain in extremity | Sore arm, stomach pain |
| 56 | 2021-04-17 | bell's palsy |
Bell's palsy; Foggy brain; Loss of feeling in lips and tongue; This is a spontaneous report from a c...
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Bell's palsy; Foggy brain; Loss of feeling in lips and tongue; This is a spontaneous report from a contactable consumer (patient, self-reported). A 56-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, lot number and expiry dates were not provided) via an unspecified route of administration, in Arm Left, on 30Mar2021 at 17:30 (age at vaccination was 56 years), as a single dose for COVID-19 immunisation. Patient's medical history included diabetes and cancer survivor. The concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (lot number and expiry dates were not provided) via an unspecified route of administration, in Arm Left, on 09Mar2021 at 03:00 PM (age at vaccination was 56 years), as a single dose for Covid-19 immunisation. On 31Mar2021 at 09:00, the patient experienced bell's palsy, foggy brain and loss of feeling in lips and tongue. Patient did not receive other vaccines within 4 weeks or prior vaccination. Patient's treatment medications included unspecified steroid for the adverse events. The patient was hospitalized for the events on an unknown date in 2021 (for two and half days). Seriousness of the events was reported as hospitalization. Outcome of events was not recovered. Information on the lot/batch number has been requested.
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| 56 | 2021-04-17 | bell's palsy |
bell palsy; Got shingles; This is a spontaneous report from a contactable consumer (patient). A 56...
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bell palsy; Got shingles; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 15Mar2021 12:00 (Lot Number: En6208), at the age of 56-years at vaccination, as SINGLE DOSE for covid-19 immunisation. Medical history was none. The patient previously took Advil and experienced allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included vitamins nos and 'Acid pill' taken for an unspecified indication, start and stop date were not reported. On 2021, the patient experienced bell palsy and shingles. The event involved physician office visit. The patient underwent lab tests and procedures which included sars-cov-2 test (Nasal Swab): inconclusive on 31Mar2021. The outcome of the events was not recovered. Therapeutic measures were taken as a result of the events which includes viral pill and strides. Follow-up attempts are completed. No further information is expected.
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| 56 | 2021-04-17 | feeling hot |
Both feet bottom of feet and top of feet extreme heat started on April 15 and still happening now S...
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Both feet bottom of feet and top of feet extreme heat started on April 15 and still happening now Since 4/15/21 had approximately 4 hrs of sleep. Not sleepy or tired. Feeling heat sensation on a scale of 1 to 10 heat is about 10. Continuous have no relief And cannot sleep
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| 56 | 2021-04-17 | night sweats | Flu like symptoms-- night sweats abs chills, low grade fever, headache, muscle aches. |
| 56 | 2021-04-17 | pain in extremity |
04/01/2021 around 5:00 PM: 1. Sore Arm, Shortness of Breath, Chest Pains, Fatigue. | Thought was He...
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04/01/2021 around 5:00 PM: 1. Sore Arm, Shortness of Breath, Chest Pains, Fatigue. | Thought was Heartburn, took tums and had a little relief 04/02 to 04/05/2021: Same Symptoms throughout those day, had No appetite, increased fatigue. and Tums No longer gave relief. 04/06/2021 6:00 AM: Went to emergency room and had to receive emergency heart surgery as I was diagnosed with blood clogged arteries and had been having a heart attack for the past several days
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| 56 | 2021-04-17 | pain in extremity |
Inflamation and pain on left side of the body, beginning in the arm/shoulder and spreading to neck a...
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Inflamation and pain on left side of the body, beginning in the arm/shoulder and spreading to neck and left tonsil. Tonsil swelling was quite pronounced by 2am (nearly twelve hours after the injection) and blocked the airway when head was turned to the left, necessitating a makeshift pillow brace to keep head turned to the right overnight. Tonsil swelling began to diminish by about 6am and only slight enlargement remains thirty hours after injection. Additionally, a low-grade fever began at about 10 pm (~7 hours after injection) and reached a maximum of 100.5 degrees F approximately twenty-four hours after the injection. By twenty-eight hours, temperature was within normal limits (though still nearly a degree higher than typical for this patient). As of this writing, some thirty hours after the injection, headache, neck ache, and eye-ache persist, but none is severe. Symptoms appear to be continuing their improvement. I (the patient/recipient) hope the second installment of the vaccine is no worse than this one. The only truly alarming symptom was the swollen tonsil and some thought was given to seeking medical attention, but the pillow brace seemed to do the trick for keeping the airway open, so no assistance was sought. I have no doubt that these short-lived symptoms are much better than actual disease and I will not hesitate to follow up with the second vaccine installment?but I will monitor the tonsil situation very carefully.
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| 56 | 2021-04-17 | tingling | Tingling, nausea, headache day of vaccination. Brain fog for following 36 hours. |
| 56 | 2021-04-19 | weakness |
For the first three days, it was severe nausea, body & head aches, tiredness with flank pain on the ...
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For the first three days, it was severe nausea, body & head aches, tiredness with flank pain on the left side toward the kidney area. Three days later, the severe nausea returned and caused weakness. The flank pain increased to my lower ribcage on the leftside and am still dealing with it. (4/20/2021)
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| 56 | 2021-04-19 | migraine |
Pfizer-BioNTech COVID-19 Vaccine EUA Severe Migrane Headache, Severe pain in left eye swelling and l...
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Pfizer-BioNTech COVID-19 Vaccine EUA Severe Migrane Headache, Severe pain in left eye swelling and loss of vision, Nausea and Vomiting, Severe Fatigue
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| 56 | 2021-04-19 | pain in extremity |
Right soleal vein DVT; patient developed signs of right lower extremity swelling, erythema, pain app...
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Right soleal vein DVT; patient developed signs of right lower extremity swelling, erythema, pain approximately 3 days after vaccination; patient presented to hospital approximately 3 weeks after these symptoms started. Was started on Xarelto in the hospital.
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| 56 | 2021-04-19 | tingling |
Injection site tenderness, ipsilateral rotator cuff tendinopathy, ipsilateral hand tingling, ipsil...
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Injection site tenderness, ipsilateral rotator cuff tendinopathy, ipsilateral hand tingling, ipsilateral medial biceps tenderness
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| 56 | 2021-04-19 | seizure | Seizure |
| 56 | 2021-04-20 | pain in extremity |
Patient states that after receiving his first Pfizer COVID19 vaccine, a previous cut that had alread...
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Patient states that after receiving his first Pfizer COVID19 vaccine, a previous cut that had already scabbed over and was healing on his arm started to swell and become infected. The initial wound has not healed and has become painful. Now, after receiving his second Pfizer COVID19 vaccine the patient has a total of 3 wounds, all circular and approximately 3/4" diameter on his arms. The additional two wounds were the same as the first, previous cuts that were healing and then turned into these identically sized & shaped wounds.
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| 56 | 2021-04-20 | pain in extremity |
Pain in bilateral lower extremities that started after 1st dose of COVID vaccine. US completed on 4/...
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Pain in bilateral lower extremities that started after 1st dose of COVID vaccine. US completed on 4/16/21 showed superficial blood clot in right leg. Treatment included: warm compresses, taking ibuprofen 600 mg with food three times daily, and elevation of your right lower extremity. Outcome: unknown.
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| 56 | 2021-04-21 | tingling, electric shock sensation, feeling of insects crawling on skin, nerve pain |
Within 30 minutes of receiving vaccination started having minor nerve sensations at random places t...
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Within 30 minutes of receiving vaccination started having minor nerve sensations at random places throughout body. The sensations (pins & needles, itching, crawling, tingling and minor energy zaps well below skin) continued regularly but were never severe. On April 10th I started taking. 1 tsp of L-glutamine Supplement which I have previously taken with no issues. Neurological paresthesia increased once I?ve started taking supplements. After about one week I made the connection and stopped. Symptoms decreased but have not ceased. Rather they went back to levels they were before taking the L glutamine.
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| 56 | 2021-04-21 | tremor, cold extremities, feeling hot |
Approximately 20 hours after receiving the vaccine, my hands and feet became very cold, and my whole...
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Approximately 20 hours after receiving the vaccine, my hands and feet became very cold, and my whole body began to shake - have chills, and my teeth began chattering. Approximately 3 hours later, I began to feel warm; my eyelids were very warm whenever I blinked. Slowly but surely I began to feel better.
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| 56 | 2021-04-22 | weakness | Headache, body aches, low grade fever and loss of energy |
| 56 | 2021-04-22 | feeling hot |
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: warmness in chest,tighte...
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Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: warmness in chest,tightening of throat, no difficulty breathing but \"funny feeling\", able to complete sentences, able to answer questions, patient is alert-Mild, Additional Details: patient describes tightening of throat, warmness of chest, no difficulty breathing but \"funny feeling\" (cottony feel according to patient) when swallowing. patient is alert, able to answer questions and able to complete sentences. pharmacist on duty immediately called 911, have epipen ready. per 911 dispatcher, rph must answer some questions first, but paramedics arrived immediately to the scene and took over. patient interviewed by paramedics and patient walked with paramedics out of building.
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| 56 | 2021-04-22 | feeling hot |
Systemic: throat thigtness, warmness in chest, no difficulty building but\"funny feeling\" when swal...
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Systemic: throat thigtness, warmness in chest, no difficulty building but\"funny feeling\" when swallowing, patient is alert, able to answer questions, able to complete sentences-Mild, Additional Details: patient describes tightening of throat, warmness of chest, no difficulty breathing but \"funny feeling\" (cottony feel according to patient) when swallowing. patient is alert, able to answer questions and able to complete sentences. pharmacist on duty immediately called 911, have epipen ready. per 911 dispatcher, rph must answer some questions first, but paramedics arrived immediately to the scene and took over. patient interviewed by paramedics and patient walked with paramedics out of building.
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| 56 | 2021-04-23 | burning sensation | Itchy, burning,painful,fine papular rash,dry and rough.10 intertriginous areas. |
| 56 | 2021-04-23 | migraine |
Systemic: Headache-Severe, Systemic: Visual Changes/Disturbances-Severe, Additional Details: Patient...
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Systemic: Headache-Severe, Systemic: Visual Changes/Disturbances-Severe, Additional Details: Patient had visual disturbances within 1 hour of vaccination and lasted for an hour. then a migraine proceeded after the visual disturbances. the migraine last 3 hours, that is the first migraine he has ever had in his life. he managed the migraine with tylenol and ibuprofen. after 3 hours the migraine turned into a headache and last until late in the evening
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| 56 | 2021-04-24 | tremor, feeling cold |
Chills starting at 5 pm day 1; severe chills and shaking for 10 minutes on preparing for bed at 8 pm...
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Chills starting at 5 pm day 1; severe chills and shaking for 10 minutes on preparing for bed at 8 pm, fever 98.9, which resolved upon lying down under warm blankets; fever 101.1 at 11 pm day 1, 102.0 at 5 am day 2, 100.7 at noon, 101.8 at 5 pm on day 2, with muscle ache and headache throughout day 2;100.5 at 2:30 am on day 3. Fever went down to 100.0 at 5 am and was normal thereafter, mild headache through daytime of day 3. No symptoms since.
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| 56 | 2021-04-25 | feeling hot, feeling cold, tremor |
Pt. received first Pfizer covid vaccine at 5:45pm. He was brought to the observation area for 30 min...
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Pt. received first Pfizer covid vaccine at 5:45pm. He was brought to the observation area for 30 minutes of observation due to hx of anaphylaxis to penicillin. At approximately 5:55pm, RNs noticed that Pt had his head in his hands. When questioned, he stated he didn?t feel well. He was helped to the ground and his legs were elevated. His vitals were 190/90, P 88, Resp 34. The nurses helped him to a sitting position as he was feeling better and he answered some medical history questions. He shared that he was Type I Diabetic. He stated he checked his blood sugar last yesterday. He ate breakfast today and took insulin. No food since this morning. Patient had no symptoms of anaphylaxis and no chest pain or other complaints. Patient denied SOB or ?throat tightening?. No hives. Patient became diaphoretic and stated he was overheated. RNs helped to remove his shirt. Observation RN alerted Nurse practitioner of the ongoing incident. Nurse Practitioner went to seek sugar sources, suspecting the patient was severely hypoglycemic. Patient, still conscious and responsive and sitting up, took 10 oz. orange juice and frosting was massaged by APRN, in buccal area with patient consent. Patient initially seemed to be improving per APRN and RNs caring for patient. BP was 170/90 at next check. P 80. Regular respirations. Still no anaphylaxis symptoms (no hives, no angioedema, no throat tightening or wheezing). A few minutes later, Pt started shaking and said he was chilled. Patient was returned to supine position with legs elevated. He continued to shake and patient lips blue ? sweatshirt placed over him. RN noted that Pts? eyes rolled back in his head. RN went to alert the Clinical Team Manager/RN of the situation and stated that 911 should be called as patient not improving. Clinic Team Manager/RN concurred. While RNs stayed with patient and informed patient?s friend about what would occur, Clinic Site Manager called 911. BP 140/80 at next check. Patient continued to sweat and have chills. Rescue squad arrived ? blood sugar was 116. After emergency services assessment of patient, emergency services checked blood sugar again and it had dropped to 88 within those ~5 minutes. Patient was taken by Emergency Services at 6:36pm. RN noted that the patient remained with emergency services in parking lot for several minutes and then pt was transported to the hospital by the emergency services. His wallet, glasses and hat were given to his friend who had accompanied patient to the vaccination clinic. His friend stated that she would call patient?s wife to inform her that patient was taken to ED by emergency services.
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| 56 | 2021-04-26 | weakness |
4-16 Friday 2nd COVID shot, feeling ok. A little tired; 4-17 Saturday tired, low grade fever, achy;...
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4-16 Friday 2nd COVID shot, feeling ok. A little tired; 4-17 Saturday tired, low grade fever, achy; 4-18 Sunday Rash on tops of both feet, tired achy, low grade fever, chills; 4-19 Monday Fatigue, slight rash on torso, feet better, low grade fever, chills; 4-20 Tuesday Rash entire torso front and back small red raised blisters, fever 100+, fatigue, easily winded and tired, runny nose, contacted Doctor, told to wait 7 days to call back if symptoms don?t improve; 4-21 Wednesday Severe Rash on torso, arms, legs, buttocks, no pain or itching; 4-22 Thursday Rash spreading to all parts of the body from head to soles of feet, difficulty breathing, fever hard to manage 101-102, mouth sores, eyes bloodshot, Went to urgent care, Negative Rapid Covid test, put on 50 mg Prednisone and 1 tab claritin; 4-23 Friday Rash more red, blisters gone no white on torso, some white areas on legs, arms, and other parts of the body. Breathing worse, coughing, chills, fever hard to manage 101-102, chills, no appetite, diarrhea, rash painful on sides of torso; 4-24 Saturday Went to ER for difficulty breathing, no unaffected skin on torso, general ill feeling, eyes still bloodshot, mouth sores, *Intravenous steroids, chest CT scan and xray showed inflamed lymph nodes, inflamed lung walls, no blood clots, bronchial walls thickening and faint peripheral ground glass opacities in the right lobe, mediastinal and right hilar lymphadenopathy as well as air-trapping in the right middle lobe and left upper lobe *strep test negative; 4-25 Sunday rash a little better after intravenous steroids, breathing worse, fever still 101-102 managing with tylenol and advil; 4-26 Monday Dermatology consult punch skin biopsy to rule out viral cause of rash, blood work done to rule out pneumonia, put on reducing course of prednisone 60/40/20/10/5 - Allergy consult no diagnosis; 4-27 Tuesday primary care doctor, added Symbocourt, rash peeling and flaking and painful, slowly receding, breathing still labored and difficult, no appetite, no energy, fatigued, eyes still bloodshot, mouth still sore and raw/canker sore like, ruled out any other cause diagnosed as vaccine reaction. Advised to contact in two weeks if breathing it still difficult.
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| 56 | 2021-04-26 | pain in extremity |
Left arm pain, hard area-lump, decreased range of motion of left upper extremity. Symptoms started w...
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Left arm pain, hard area-lump, decreased range of motion of left upper extremity. Symptoms started within a few hours after vaccination and have worsened over the past 6 weeks. Symptoms still present.
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| 56 | 2021-04-27 | feeling of body temperature change | Flu like symptoms. Body aches, hot and cold with chills, bad headache, back hurts, slight fever |
| 56 | 2021-04-27 | numbness |
185/100 blood pressure (usually 130/75) high heart rate; cheeks feeling numb; airplane ear; lasted a...
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185/100 blood pressure (usually 130/75) high heart rate; cheeks feeling numb; airplane ear; lasted about an hour and a half; felt week for three days after with slight chest pain. very similar symptoms but lasting much longer occurred again 04/27/2021
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| 56 | 2021-04-28 | feeling hot |
Within 10-minutes of vaccination, the patient experienced dizziness and a syncopal episode. EMS eval...
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Within 10-minutes of vaccination, the patient experienced dizziness and a syncopal episode. EMS evaluated the patient on-site. The patient was hypotensive (86/53) with a FSBG of 98mg/dL. EMS administered 700mL IV normal saline. EKG was normal. EMS transported to Hospital Emergency Department. En-route to ED, the patient's blood pressure improved (146/97) with fluids. In the ED, the patient stated that their syncope was preceeded by "feeling very warm" and nausea, but now feels improved with fluids. Labs and tests were unremarkable. Physician discharged the patient with diagnosis of vasovagal like syncope.
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| 56 | 2021-04-28 | numbness |
Pt c/o Left side facial numbness from eye socket to chin noted after he got home from receiving th...
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Pt c/o Left side facial numbness from eye socket to chin noted after he got home from receiving the second Covid vaccine on 4/27/21. This started on Tuesday but is now beginning to diminish. No effects to vision , smell, taste or hearing, Pt did not have any drooling or numbness inside mouth or bite marks. No tingling on scalp or neck area, only front facial numbness, no other numbness on body occurred.
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| 56 | 2021-04-28 | pain in extremity |
2 days after second COVID vaccine patient began to have purple spots on his legs and erythematous sp...
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2 days after second COVID vaccine patient began to have purple spots on his legs and erythematous spots on the rest of his body. lower extremity rash become bullous purpura with eventually necrotic tissue in the center of the larger lesions that became up to 3 inches in diameter and many 1/2 inch to inch size lesions as well. swelling of ankles and feet all causing severe pain. seen over several weeks and had biopsy and placed on Norco for pain control and prednsione for inflammation.
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| 56 | 2021-04-28 | tingling |
Patient is a 56yo male who presents for evaluation of symptoms of paresthesia that he experienced af...
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Patient is a 56yo male who presents for evaluation of symptoms of paresthesia that he experienced after receiving the first Pfizer COVID-19 vaccine. He received the first dose on April 10th at 0900 at a church near his home. 15 minutes after receiving the vaccine he reports experiencing sensation of pins and needs of his tongue, lip and face. He left the vaccine site and the symptoms became more noticeable. 90 minutes after the injection he took Benadryl which resolved his symptoms of pins and needle sensation, but it returned 4 hours later. He continued to take Benadryl every 4-6 hours from the 10th to the 14th until finally he decided to stop by the Emergency Department. There he was given a 5 day course of prednisone (40mg daily) and switched from Benadryl to Zyrtec BID. He reports good symptoms control on the Zyrtec but states that it still doesn?t feel completely resolved. He didn?t feel like the steroids helped at all. If he misses a dose of Zyrtec he feels the symptoms start to worsen again which prompts him to take another dose of Zyrtec. He denies any numbness, tingling, weakness anywhere else on his body. He denies difficulty speaking or swallowing. He has not experienced any syncope, shortness of breath, hives, flushing, vomiting, or diarrhea in conjunction with the injection. The only other time he has experienced symptoms like this was when he was given an IM injection of PCN > 10 years ago. He was then given a one-time dose of Benadryl and the symptoms resolved within an hour and never returned.
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| 56 | 2021-04-29 | bell's palsy | patient with bells palsy 1 day after covid vaccination - on the left side of the face |
| 56 | 2021-05-01 | tingling, numbness |
Tingling in left arm and hand/fingers, numbness in hand. Constant first 2 weeks then intermittent. ...
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Tingling in left arm and hand/fingers, numbness in hand. Constant first 2 weeks then intermittent. Still occurring intermittent (a couple hours a day). Had second shot 4/26
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| 56 | 2021-05-03 | pain in extremity |
ON 4/28 felt intense pain in legs and blurry eyes, slowly went away after taking advil, came back at...
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ON 4/28 felt intense pain in legs and blurry eyes, slowly went away after taking advil, came back at night, on thursday 4/29 pain continued and had shortness of breath decided to go to urgent care made appt for 4/30 813AM, at Urgent Care symptoms pointed to blood clots was told to go to local imaging company to get sonogram, sonogram showed blood clots in leg told to go to emergency room, went to Hospital and was admitted, confirmed blood clots and put on blood thinner neprin IV, released 5/2 at 1PM, at home now on blood thinner pills 10mg Eliquis
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| 56 | 2021-05-03 | tingling, numbness |
blood clot at upper right chest underneath collar bone; Swollen right arm and fingers; tingling and ...
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blood clot at upper right chest underneath collar bone; Swollen right arm and fingers; tingling and numbness in arm; numbness in arm; headaches; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration, administered in Arm Left on 08Apr2021 04:00 (Lot Number: EWO153) as SINGLE DOSE for covid-19 immunisation. Medical history included Implantable cardioverter defibrillator insertion from 2005. Concomitant medication in two weeks included verapamil 120 mg. No other vaccine in four weeks. No Covid prior vaccination. No Covid tested post vaccination. No Known allergies. On 12Apr2021, the patient experienced blood clot at upper right chest underneath collar bone. Swollen right arm and fingers with tingling and numbness in arm. Also, suffering from occasionally headaches. The patient was relatively heathy with no know blood clot issues. Events resulted in Doctor or other healthcare professional office or clinic visit. Unknown if treatment was received for events. The outcome of events was not recovered.
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| 56 | 2021-05-05 | bell's palsy, facial paralysis |
woke up on 3/23 with left facial paralysis; confirmed no balance, cognitive or motor function loss M...
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woke up on 3/23 with left facial paralysis; confirmed no balance, cognitive or motor function loss Met with Dr on 3/24. Confirmed Bells Palsy. Started on Valtrax (7 days) and Prednisone (10 days) Now 6 weeks post-event; have some movement on left side of face; estimate 40% recovery so far No plans for additional medication No plans for 2nd dose due to uncertainty on how it will impact current condition
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| 56 | 2021-05-05 | facial paralysis, bell's palsy |
Woke up 3/23 with left facial paralysis 3/24 Dr visit confirmed Bells Palsy. Started on Valtrex (7 ...
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Woke up 3/23 with left facial paralysis 3/24 Dr visit confirmed Bells Palsy. Started on Valtrex (7 days) and Prednisone (10 days) 6 weeks later, starting to see some improvement on left side
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| 56 | 2021-05-10 | weakness | WEAKNESS AND COUGH COVID-19 pneumonia and urinary retention |
| 56 | 2021-05-12 | pain in extremity |
sore arm; headache; transitory fever for about one hour; This is a spontaneous report from a contact...
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sore arm; headache; transitory fever for about one hour; This is a spontaneous report from a contactable pharmacist. A 56-years-old male patient received second dose of bnt162b2 (BNT162B2 solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 27Jan2021 as single dose for covid-19 immunisation. Medical history included seasonal allergy. The patient's concomitant medications were not reported. He received his seasonal allergies SC injection 24 hours before receiving the second BNT 162 b2 injection. patient reports that he received his seasonal allergies SC injection 24 hours before receiving the second BNT 162 b2 injection on 27Jan2021 in his right deltoid muscle. Patient also reports that he took 50mg of Benadryl prior to his BNT162b2 injection. A couple hours after receiving the BNT 162b2 vaccine he experienced a transitory fever that lasted 1-2 hours and resolved. The next morning,28Jan2021, patient stated that he had a headache that lasted for a day and a half which was unresolved by sleep or ibuprofen, 400 mg taken 3-4 times in the day and 1/2 time period. On Thursday 28Jan he noticed a lump in his Right arm pit which was visible and sore. The lump resolved by after 4-5 days and he has been symptom free. On 27Jan2021, the patient experienced transitory fever for about one hour and sore arm, headache on 28Jan2021.The outcome of the events was recovered. This is a supplement to the previous report submitted 28Jan. Patient emailed (Name) with additional information pertaining to the original report, information was added. Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
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| 56 | 2021-05-18 | tingling | Error: Shoulder Joint Injury (prolonged pain, tingling, etc.) |
| 56 | 2021-05-20 | discomfort, burning sensation |
LUQ Abdominal Pain: Patient reports that he was in his usual state of health until last week when he...
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LUQ Abdominal Pain: Patient reports that he was in his usual state of health until last week when he received his COVID 19 vaccination. He received 1st dose of Pfizer vaccination. Prior to this he was healthy. He reports 10 minutes after injection, he felt a knot/burning sensation in the LUQ of his abdomen. He states that it progressively worsened to the point where he couldn't sleep the following night. Over the weekend, he felt like he was improving. However, last night it was significantly uncomfortable. He feels an achiness/bruising sensation over his LUQ. He reports that there is a baseline discomfort but then it will become so bad that he has a hard time walking. He states that if he gets in a certain position he will feel improved but if he moves the wrong way it feels like it pinches. No changes with food. He reports decreased appetite. No fever, chills, nausea or vomiting. He had diarrhea x 1. No constipation.
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| 56 | 2021-05-21 | tremor, limb paralysis |
Caller has previously been diagnosed with arthritis, fibromyalgia and acid reflux. On Sunday, 09 May...
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Caller has previously been diagnosed with arthritis, fibromyalgia and acid reflux. On Sunday, 09 May 2021, at 4:00PM, at that time, all three activated at once; Caller has previously been diagnosed with arthritis, fibromyalgia and acid reflux. On Sunday, 09 May 2021, at 4:30PM, at that time, all three activated at once; Caller has previously been diagnosed with arthritis, fibromyalgia and acid reflux. On Sunday, 09 May 2021, at 4:30PM, at that time, all three activated at once; his arm pain became sever; Caller had pain at the injection site; He felt his arm shutting down from his shoulder to his fingers, becoming paralyzed; felt shaky inside; did not sleep at all; This is a spontaneous report from a contactable consumer (Patient) The 56-year-old male patient received first dose of BNT162B2 (Solution for injection, Lot number unknown), via an intramuscular route of administration (standard 0.3mL according to patient) on 07May2021 at 02:30 PM (at the age of 56-years), for COVID-19 immunization. The patient had a family and medical history of hypertension but was not on any medications. He was on blood pressure medication (unspecified) but they took him off because he was doing fine. He had been diagnosed with arthritis, fibromyalgia and acid reflux. The patient was allergic to Tetracycline: His arm shutting down, and being paralyzed after taking tetracycline happened years ago and the paralysis was much more severe. They told him no more tetracycline for him, and he has not taken it since. He got a flu shot 26 years ago, and it put him in the hospital. He has not had a flu shot since. The patient did not receive any vaccines within 4 weeks prior vaccinations. Patient had no history of other previous immunization with the Pfizer vaccine or additional vaccines administered on same date of vaccination Concomitant medications were not reported. After first dose on 07May2021, patient had a rough time from it and felt some pain in the injection site, right after he went down to rest and felt shaky inside. Shakiness occurred right after the injection, it was subtle and at 8:00 PM his arm pain became severe, as it went on, he did not sleep at all. Patient arm pain went through out Friday night, and into Saturday morning. His arm pain was gone by 5:00 AM on Saturday morning. He felt his arm shutting down from his shoulder to his fingers, becoming paralyzed. At 8:00 AM Saturday, the paralysis sub-sided partially and at 5 pm that day he was perfectly fine. On Sunday, 09May2021, at 4:00 PM, all three: arthritis, fibromyalgia and acid reflux activated at once with no warning. That morning he had no symptoms except from the arthritis pain. He made a VAERS report and that his doctor recommended taking Ibuprofen right after taking his second dose. Event did not require Emergency Room/ Physician Office visit. He was scheduled to receive the second dose on Friday 28May2021, but due to his doctor suggestion he would like to know if he can reschedule it for Thursday 27May2021. The outcome of the events of arm shutting down from his shoulder to his fingers, becoming paralyzed; his arm pain became severe; pain at the injection site; did not sleep at all was recovered on 08May2021, and events fibromyalgia and acid reflux on 11May2021, felt shaky inside was recovered on an unspecified date in May2021, while that of arthritis was unknown. Information on the lot/batch number had been requested.
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| 56 | 2021-05-23 | pain in extremity |
PATIENT IS COMPLAINING OF RIGHT ARM PAIN. SAYS THAT THE DR HAS DETERMINED THAT HE HAS A TEAR IN HIS ...
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PATIENT IS COMPLAINING OF RIGHT ARM PAIN. SAYS THAT THE DR HAS DETERMINED THAT HE HAS A TEAR IN HIS RIGHT ROTATOR CUFF
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| 56 | 2021-05-24 | pain in extremity |
Sore arm; fever of 100.2; Blood sugar keeps dropping; This is a spontaneous report from a contactabl...
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Sore arm; fever of 100.2; Blood sugar keeps dropping; This is a spontaneous report from a contactable consumer (patient). A 56-years-old male adult patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN5318), via an unspecified route of administration, administered in Arm Right on 28Jan2021 14:30 as 1ST DOSE, SINGLE for covid-19 immunization. No Known allergies. Facility type Vaccine was Workplace clinic. No other vaccine in four weeks. No covid prior vaccination, No covid tested post vaccination. Medical history included hypertension, diabetic. Concomitant medications in two weeks included metformin (METFORMIN); nebivolol hydrochloride (BYSTOLIC). On 28Jan2021, the patient experienced sore arm, fever of 100.2, blood sugar keeps dropping. No treatment provided for the events. The patient underwent lab tests and procedures which included blood sugar keeps dropping, body temperature was 100.2. The outcome of all the events was not recovered. Follow-up attempts are completed. No further information is expected.
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| 56 | 2021-05-25 | pain in extremity |
Fatigue; Headache; Right arm pain; Muscle soreness; This is a spontaneous report from a contactable ...
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Fatigue; Headache; Right arm pain; Muscle soreness; This is a spontaneous report from a contactable consumer or other health professional. A 56-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL3247), via an unspecified route of administration in the right arm on 15Mar2021 at 14:30 (at the age of 56-years-old), as a second single dose for COVID-19 immunisation. The patient also received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL3247), via an unspecified route of administration in the right arm on 22Feb2021 at 14:45 (at the age of 56-years-old), as a first single dose for COVID-19 immunisation. No relevant medical history and concomitant medications was reported. The patient did not have any known allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 16Mar2021, the patient experienced pain in right arm, headache, fatigue, and muscle soreness. There was No fever or other symptoms. The patient received Tylenol 500 mg for the adverse events. The clinical outcome of right arm pain, headache, fatigue, and muscle soreness was recovering. No follow-up attempts are possible. No further information is expected.
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| 56 | 2021-05-26 | weakness, pain in extremity |
couple pains in the left chest area behind the breast; his stomach was feeling sick and his body was...
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couple pains in the left chest area behind the breast; his stomach was feeling sick and his body was hurting; His whole torso hurt and his stomach; The pain now is not like where it hit him with the back. He has back pain every day but more than he used to. the back pain was just the one day.; his arm was a little sore; He was lethargic and had no energy; He was lethargic and had no energy/weakness; diarrhea; Responding strangely to people/but is still there and is so weird; dizzy; getting really irritable; Slept all day for several days; Arm started hurting where he got the shot; been sick pretty much everyday; not feeling good in his stomach; he passed out for 2 days; breathing hard; wouldn't feel good; a fast heartbeat; chills; nausea; headache; he gets really short and impatient; forget a little something still, but just once in a while; This is a spontaneous report from a contactable consumer (patient). A 56-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 07Apr2021 14:30 (Lot Number: WR8783) as 1ST DOSE SINGLE for covid-19 immunisation. Medical history included ongoing sciatica, back problems, stomach was sensitive, lower back pain, bone spurs down his spine. He was a medical marijuana patient, he had Shigella when he was a baby. He was 2 or 3 and almost died but came out of it; His mom had cancer from smoking, he got the worse flu sick of his life. His stomach was sensitive all of the time. If he was too happy or too nervous get upset. He can eat spicy food, not super hot, but he can eat anything and it doesn't go crazy. He has a little bit of a sensitive stomach sometimes. He can't take a multivitamin or supplements because he would get sick to his stomach, this was before the vaccine. He was getting that same sick feeling now that he would get if he was taking a multivitamin. He had his blood drawn a week before he had the vaccine to check his kidneys with the pills he is on. It was perfect and normal, and he has had nothing since then. In his 20s he had the flu vaccine, and he had never had the flu in his life. That year he got the worse flu sick of his life. He never got the flu vaccine or other vaccines after that. That was probably between 1987 to 1990. His folks passed away. He had been in the hospital when he was little.Concomitant medications included acetaminophen taken for back pain, sciatica from an unspecified start date and ongoing; nabumetone taken for sciatica, back pain from an unspecified start date and ongoing. The patient experienced he passed out for 2 days (medically significant) on Apr2021 with outcome of unknown, been sick pretty much everyday (non-serious) on 07Apr2021 22:00 with outcome of not recovered, not feeling good in his stomach (non-serious) on 07Apr2021 with outcome of not recovered, slept all day for several days (non-serious) on 08Apr2021 with outcome of unknown, responding strangely to people/but is still there and is so weird (non-serious) on 12Apr2021 with outcome of not recovered, his stomach was feeling sick and his body was hurting (non-serious) on 15Apr2021 with outcome of not recovered, his whole torso hurt and his stomach (non-serious) on 15Apr2021 with outcome of unknown, diarrhea (non-serious) on 12Apr2021 with outcome of not recovered, getting really irritable (non-serious) on 09Apr2021 with outcome of not recovered, he had no energy (non-serious) on 12Apr2021 with outcome of recovering, he was lethargic/weakness (asthenia) (non-serious) on 12Apr2021 with outcome of not recovered, dizzy (non-serious) on 10Apr2021 with outcome of not recovered, couple pains in the left chest area behind the breast (non-serious) on 17Apr2021 with outcome of not recovered, breathing hard (non-serious) on Apr2021 with outcome of not recovered, wouldn't feel good (non-serious) on Apr2021 with outcome of not recovered, arm started hurting where he got the shot (non-serious) on 08Apr2021 with outcome of not recovered, headache (non-serious) on Apr2021 with outcome of unknown, his arm was a little sore (non-serious) on 13Apr2021 with outcome of unknown, a fast heartbeat (non-serious) on Apr2021 with outcome of unknown, chills (non-serious) on Apr2021 with outcome of unknown. Patient got sick around 10:00 at night. He was supposed to get his second dose but he was so sick and they said lets give it a week. Then he talked to his doctor and he said to wait 2-3 weeks to make sure he is back to normal. So he is scheduled for the second dose next week at 6 weeks. He asked if it was okay that the shot was given in the sunlight. He stated that he saw that it was in an ice chest but the person had to walk it over to him 20 feet and deal with his sleeve for a second or two so it was in the sun. He said all that walking it was 100% in the sun and he has read that it should not be in the sun. He asked if this could have caused bacteria and caused his symptoms. He stated his doctor was only concerned about giving him antibiotics for bacteria if it was in the sun and if that was a problem. He just read from CDC, once mixed the vaccine can be left at room temp for 6 hours and mixed vaccine does not need to be protected from light. So it sounds like his first shot was good. He had gotten the shot at about 1430 in the afternoon. He was like he is going to get the shot and everything will be great. He didn't think there would be an effect. Then strangely enough at about 2200 he was about to eat dinner and he got to not feeling good in his stomach. It had been close to 8 hours. The next day he slept all day, got up and had coffee, and Saturday he was in the chair in the living room. He is never in the chair during the day because he works. He slept all day and all night and the next day. He was responding strangely to people, and he was in and out of it. He had the shot on Wednesday and then his stomach was feeling sick and his body was hurting. He has back pain anyway and bone spurs on his spine. He was telling his wife whatever pain he is normally in was enhanced. His whole torso hurt and his stomach. The following Monday he had diarrhea. Then he started getting really irritable and didn't want to talk and was impatient. He was lethargic and had no energy. That was the second week. By the end of the second week he had a couple pains in the left chest area behind the breast. He thought it was a heart attack, then thought it was just pain not a heart attack. Every time he wouldn't feel good he would start breathing hard. Once in a while he gets pain through his chest area. His stomach would start and he would breath hard every time he didn't feel good. The third week he was supposed to get the second shot. He called the department of health for New Mexico. The nurse called back and said not to do the shot that week but to wait a week. He rescheduled for a week later. By the third week he was still not feeling good and called the doctor. He asked about the pain in his chest 3 times and he said it seemed to be okay. His arm started hurting where he got the shot in the second week. He still had no energy and he told the doctor this. Patient started taking 2 extra Tylenol during the day for pain. Lately he has been good until one little thing and then all of a sudden his stomach is hurting and he is holding his stomach. He was good today, all he did was eat a cookie and he didn't get sick. He was worse for a little while in the first or second week, he was really bad. It came and went over the next 2 weeks and now it is coming and going less frequently. He slept through 2 or 3 days. Thursday, Friday, and then Saturday he was in and out. He woke up to take the garbage out on Friday then saw he already took it out and forgot it was out there. And it was Saturday. He was kind of out of it. When he would respond strangely he would respond with a question he just asked and someone answered. It is like brain fog or like he is on something. It started after the weekend, more on 12Apr2021. Once in a while he will forget a little something still, but just once in a while. He would walk and hold his rib cage with both arms when he was hurting. He wrote down that it felt like somebody had hit him in the back with a bat in the lower back. One day it was that bad. His back pain was on Thursday 15Apr2021. The pain now is not like where it hit him with the back. He has back pain every day but more than he used to. The sore like he was hit in the back pain was just the one day. He had diarrhea 12Apr2021, 13Apr2021, and 14Apr2021 then it left for probably a week. Then it came back last week one day. Instead of every day it was every 3 or 4 days. He has not had it in the last 4 days. He hopes it is done. He noticed any time he has salad or lettuce he feels bad in the morning so he stopped eating those. He felt irritable more when he started not feeling good. The last 5 days or so more towards the evening at 1800 or 1900 he starts not feeling good and gets irritated. His wife will ask him something and he gets really short and impatient. He felt irritable more when he started not feeling good. The last 5 days or so more towards the evening at 1800 or 1900 he starts not feeling good and gets irritated. His wife will ask him something and he gets really short and impatient. The irritable feeling started right away the Friday of the week he got the shot. He is still struggling some, it will come and go. Yesterday he was zonked. With having no energy it is a big thing. He has to do something instead of what he would be doing. He works all day and takes long orders and stuff. Now he does like one order when normally he did 10. One for him is a huge little sore so he will lay on his right side. His left arm still hurts like a pulling hurt from his neck to his arm. It has been every day from 13Apr2021. It is much better and he will move and it will relax a little bit. It was really weird. The whole time he held the phone with his left hand up until one second he moved his phone and it was the same pain. At night the left side where he had the injection pulls on his neck muscle coming from his arm. He was actually taking two Tylenol in the morning and two at night when he went to bed. With the pain he takes 2 during the day, 650mg each. He was just taking 500mg and then his wife said take these. It seems to have gotten a little better. He always took them 2 times a day and now he takes them 3 times a day. After the first dose he experienced difficulty breathing dizziness, weakness, a fast heartbeat, chills, nausea, headache, he passed out for 2 days and has been sick for 5 weeks. He started having some dizziness a couple of days later and reports, it's like I would stand up too quickly and get a head rush, that kind of dizzy feeling. He confirmed that his dizziness did not start until a couple of days after he received his first dose.
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| 56 | 2021-05-28 | numbness, tingling, burning sensation |
Within a week after first vaccine dose, burning in legs from above the knee to feet. Numbness and ti...
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Within a week after first vaccine dose, burning in legs from above the knee to feet. Numbness and tingling in fingers and feet. Symptoms continue. Within a week after second vaccine, onset of bilateral upper quadrant pain, thoracic and flank pain that worsened over time. Unable to lie down due to sharp pain. Reached out to Oncology and PCP offices after symptoms of both vaccines for awareness and guidance. 5/4/21 - Emergency and inpatient visit - diagnosed with bilateral pulmonary emboli.
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| 56 | 2021-05-30 | slurring |
Pain in my jaw and temple to start then my words started to slur then created a stroke and confirmed...
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Pain in my jaw and temple to start then my words started to slur then created a stroke and confirmed my the hospital. I have had a CT scan them MRI. I am in ICU. Who is going to pay for my bills since I have no insurance.
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| 56 | 2021-06-02 | flushing |
09:12, PA-C informed pt. was getting flushed right after receiving the second dose of Pfizer vaccin...
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09:12, PA-C informed pt. was getting flushed right after receiving the second dose of Pfizer vaccine. Pt. immediatly assessed: AAO x 3 and in no distress. Pt. states hx. of this reaction with vaccines and allergy shots. Pt. states he had similar reaction after the 1st Pfizer vaccine. Pt. was given Benadryl on the 1st vaccine and symptoms resolved. Currently, no breathing or swelling issues but, remains flushed on face, upper chest and arms. Does not appear to be hives. At 09:15 Pt. given Benadryl 25mg liquid. VSS stable, 65hr, 96% O2. 09:20 flushing on skin almost gone and pt. reports feeling better with no complaints. 09:28 pt. discharged to leave clinic.
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| 56 | 2021-06-02 | numbness, weakness |
Numbness and pain in his arm where the shot was given and then continued to his left shoulder.; Numb...
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Numbness and pain in his arm where the shot was given and then continued to his left shoulder.; Numbness and pain in his arm where the shot was given and then continued to his left shoulder.; Numbness and pain in his arm where the shot was given and then continued to his left shoulder.; Back hurts; Severe fatigue; He feels dizzy; Does not feel well; Coughing; Sore throat; Wasn't eating/Not eating; Body aches; Feeling down; Weak; Eyes burning; Headache/a very bad headache; This is a spontaneous report from a Pfizer sponsored program, report from a contactable consumer (patient). A 56-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0186), via an unspecified route of administration on 24May2021 (at the age of 56-years-old) as single dose for COVID-19 immunisation.The patient medical history included COVID-19 in December 2020. The patient concomitant medications were not reported. On 25May2021, the patient experienced numbness and pain in his armed where the shot was given and then continued to his left shoulder and body aches, feeling down, weak, a very bad headache, eyes burning, backed hurt, severe fatigue and he felt dizzy and he had a coughed and fatigue, sore throat, not ate. Patient states that he did some construction worked yesterday before receiving the vaccine and next day he have had been experienced the same symptoms when he had covid-19 in december 2020. Patient states he knew that the vaccine has not had anything in it that would caused him to got covid-19 so he would liked to knew if his side effects were normal. Patient would also liked to knew what could've he took to eased his headache. Patient took Tylenol and it hadn't worked. He also put ice and cold watered on it. Patient states if his symptoms were not better by next day then he would contact a health care provider. Patient states when he had covid-19 in december he was a little sick but hadn't require hospitalization and his oxygen level was between 90-92. He was not experienced a fever or chest pain as he did when he had covid-19. He was positive for covid 19 in december and had coughing, sweating, sore throat, wasn't ate, body aches, feeling down, feeling weak, eyes burning, backed hurting, headache, chest pain, and sweating. After reading the side effects that had been reported patient states he was experienced everything he mentioned except a fever, rash, itching, hives and swelling of the faced. He was fine after the covid vaccine. Next day he have had all the symptoms that he listed that he had when he had covid 19 except for the chest pain and sweating. Patient states that he just wants to knew what he could've took and did. Patient took Tylenol. He have had Tramadol but he hadn't taken it. Patient states he has not wanted have been on the phone long because he has not felt well. He stated that he knew he hasn't had covid 19 again and stated that he may did a report later. The outcome of the events was unknown. PSCC Communication: Warm transfer to (withheld) at company attempted. INT-#. Caller disconnected right before the transfer. (withheld) from company, caller states that she will reach out to the caller.
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| 56 | 2021-06-02 | numbness |
Patient stated he was encouraged by friend to call health dept now because his effects after the sho...
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Patient stated he was encouraged by friend to call health dept now because his effects after the shot didn't seem normal. He stated appx 50 minutes after shot #1 (4-1-2021), he had c/o of H/A that lasted 1 wk, brain fog for 1 wk, stomach cramps for 2 days & achy x1 wk, sore arm. He stated 90 minutes after 2nd shot (4-23-2021) he had c/o pounding H/A, arm fatigue, feverish off n on for 1 wk, all 4 extremities (hips to toes, shoulders to fingers) went numb for 2 hours & head fog for 2 days. No vaccines prior to covid vaccine. No issues with health history. Advised to call PCP with his complaints of side effects after the covid vaccine to decide about future booster doses, if they are offered in the coming months.
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| 56 | 2021-06-05 | flushing, feeling hot, weakness |
Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-M...
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Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Systemic: Weakness-Mild, Additional Details: Patient fainted after 15-20 minutes of getting vaccination. He said he felt overheated and exhausted before passing out. Gave him ice pack and water and had him lie down for several minutes. His bloodpressure was low then rose after a few minutes. Patient declined to be checked out by EMTs and stated was fine to go home and lay down. Figured he was probably anxious about getting the shot
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| 56 | 2021-06-05 | numbness, feeling hot, tingling |
5 minutes after vaccine stomach and sides felt heat, upset stomach, lightheaded and blood pressure e...
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5 minutes after vaccine stomach and sides felt heat, upset stomach, lightheaded and blood pressure elevated way up. felt very sick, went thru 3 extended observations that lasted about 1 hour and things started to calmed down except light headed and anxious. Finally felt like I could drive home then while driving home my temple and side face started tingling and went numb, pain in the back of my right eye this lasted about 20 minutes and the numbness went away however I had a sensation for a week in my temple and forehead. Could not go to work the next day, felt bad on and off for 8 days. Triggered anxiety for several days, did not get second dose..
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| 56 | 2021-06-06 | nerve pain |
About 16 days after the 2nd shot, I began feeling very tired, fatigued, nauseous, and had a headache...
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About 16 days after the 2nd shot, I began feeling very tired, fatigued, nauseous, and had a headache. About 18 days after the shot, I still had the same symptoms but also developed a red rash on my left upper bac, left arm, and left shin. The rash was painful and burned. When touched, I could feel the pain shoot through my nerves. I was seen by the PA referenced above, who treated it as shingles, but diagnosed it as a plant based reaction, as he could not be sure it was shingles. I was prescribed Mupirocin and valACYclovir HCI. I still had the fatigue and nausea for several days after starting the medication. Despite receiving my 2 shingles vaccinations in September and December of 2020, it appears the Pfizer vaccine may have triggered a mild case of shingles.
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| 56 | 2021-06-07 | weakness |
This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient rece...
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This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in arm left on 25Feb2021 13:00 (Batch/Lot number was not reported) as single dose at the age of 56-year-old for COVID-19 immunisation, administered at hospital. Medical history included known allergies to nut, ongoing hospitalisation Vaccine received during existing Hospitalization. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication(s) included levothyroxine (LEVOTHYROXINE) at 112mcg, and isosorbide mononitrate (ISOSORBIDE MONONITRATE) at 60mg, both taken for an unspecified indication, start and stop date were not reported. The patient had not received other vaccines within 4 weeks prior to BNT162B2. The patient experienced tightens of chest, difficult breathing, light headed, pulmonary embolism on 26Feb2021. The outcome of events was not recovered. The patient was hospitalized for events in 2021 for 21 days. Seriousness criteria for the evens were Life threatening and prolonged hospitalization. The patient underwent lab tests and procedures which included Sars-cov-2 test (nasal swab): negative in Sep2020. Therapeutic measures were taken as a result of tightens of events. Information on the lot/batch number has been requested.
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| 56 | 2021-06-07 | pain in extremity |
feel a constant and migrating thrombosis/palpitations on the right side of my head; palpations; mild...
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feel a constant and migrating thrombosis/palpitations on the right side of my head; palpations; mildly painful -not quite a headache; painful sensations in the lower left leg; a slight discomfort of the arm where the shot was administered; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in right arm on 11May2021 10:30 (at the age of 56 years old) (Lot Number: EW0182) as 1st dose, single for COVID-19 immunization. Medical history included high blood pressure, allergies: contrast dye. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were not any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient reported that there was a slight discomfort of the arm where the shot was administered (11May2021) - not enough to worry about & expected. The next morning (12May2021) he felt painful sensations in the lower left leg - sensations similar to stress fractures and palpations. It subsided and has not returned. About three/four days later (reported as 14May2021 18:00) continuing two weeks leading to the second dose - he felt a constant and migrating thrombosis/palpitations on the right side of his head. It was mildly painful - not quite a headache yet persistent and localized to the RT temporal lobe above the temple & slightly above that region. It became exacerbated by critical thinking when it occurred & persisted for long periods of time. The cognitive effect has become slightly debilitating & stressful. No treatment received. The outcome of the event 'a slight discomfort of the arm where the shot was administered' was unknown, of the event 'painful sensations in the lower left leg' was recovered, of the other events was not recovered.
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| 56 | 2021-06-08 | pain in extremity |
Joint pain in fingers and toes. 2 days later, it was better except for 2 fingers. (Left thumb and l...
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Joint pain in fingers and toes. 2 days later, it was better except for 2 fingers. (Left thumb and left ring finger). Now after 2 months, both fingers still have pain and limited mobility. (Can not make a closed fist)
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| 56 | 2021-06-08 | throat numbness, muscle twitching, numbness | Facial numbness, traveling down to neck, throat, and Shoulder. Muscle twitching, mainly at night. |
| 56 | 2021-06-09 | numbness |
Patient said he is experiencing shooting pain and numbness in his left arm. The same as the inject...
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Patient said he is experiencing shooting pain and numbness in his left arm. The same as the injection site. It has been 34 days since his vaccination.
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| 56 | 2021-06-09 | tingling |
Pfizer 2nd dose.. stared with tinging in eyelids, 30 seconds of tingling in arms, tingling in lower ...
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Pfizer 2nd dose.. stared with tinging in eyelids, 30 seconds of tingling in arms, tingling in lower legs, blood pressure was low100/61(took blood pressure twice). After calling paramedics, discoloration in face, also felt like he was going to pass out.
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| 56 | 2021-06-09 | tremor |
felt a "rush" and shakiness as if I just had a cup of coffee; felt a "rush" and shakiness as if I ju...
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felt a "rush" and shakiness as if I just had a cup of coffee; felt a "rush" and shakiness as if I just had a cup of coffee; felt nervous; This is a spontaneous report from a contactable consumer (patient's himself). A 56-year old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via unspecified route of administration in the left arm (Batch/Lot number unknown) on 06Mar2021 at 09:30 AM at the age of 56-year old as single dose for Covid-19 immunization and alprazolam (XANAX) 0.25 mg two hours before the vaccine (06Mar2021 at 07:30 AM) Relevant medical history included high blood pressure. Concomitant medications were not reported. The patient reported that he was very relaxed and calm and had taken less than 0.25 mg of alprazolam two hours prior. In less than two minutes after receiving the injection he felt a "rush" and shakiness as if he just had a cup of coffee. He was not short of breath and had no other symptoms. The patient tried to remain calm. The symptoms subsided in less than 30 seconds. He still felt nervous but may have been out of concern after the "rush" feeling. The site monitor approximately 8 mins. after the injection asked him how he was doing. He told him he was shaky but may have been nervous. He said he was free to leave. The patient took alprazolam that morning because he had prior Emergency Medical experience and was aware of potential anaphylaxis. The outcome of the events was recovered. No follow-up attempts are possible. Information on Lot/batch number cannot be obtained.
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| 57 | 2021-01-05 | pain in extremity |
Four days after immunization onset of arthropathy in left fifth toe (red, pain, edema) progressed o...
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Four days after immunization onset of arthropathy in left fifth toe (red, pain, edema) progressed on seventh day with enthesitis /Swelling left medial malleolus. Day 12 progressed to tender, swelling Achilles? tendon left side, day 14 stiff great toe and foot edema. Difficulty ambulating on left foot. Prednisone prescribed but not started to this point. This flare similar to IBD arthropathy in past but have been in remission until vaccinated.
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| 57 | 2021-01-08 | flushing |
3 am chills, headache and dry throat, 9:30 am chills, headache and dry throat and I took my first te...
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3 am chills, headache and dry throat, 9:30 am chills, headache and dry throat and I took my first temp 102. took two Tylenol and temp went down. 8Pm I was flush and my temp was 105.5, 5minutes later 106. PCP called and advised my wife to take me to the ER and took two more Tylenol. Arrived at ER Temp was down 100.2
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| 57 | 2021-01-11 | feeling hot, feeling cold |
Achy Joints, Cold and hot at the same time, headache on 1-10-2021 from 2am until 2pm. Took Aleve at ...
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Achy Joints, Cold and hot at the same time, headache on 1-10-2021 from 2am until 2pm. Took Aleve at 10am
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| 57 | 2021-01-11 | night sweats |
Night sweats x 4 hours and fatigue x 48 hours despite alternating ibuprofen 800 mg q3h with acetamin...
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Night sweats x 4 hours and fatigue x 48 hours despite alternating ibuprofen 800 mg q3h with acetaminophen 1000 mg from time of vaccination
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| 57 | 2021-01-11 | pain in extremity |
He received the first dose of the Covid-19 Vaccine on 18Dec2020/ received the second dose of Covid-1...
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He received the first dose of the Covid-19 Vaccine on 18Dec2020/ received the second dose of Covid-19 vaccine 04Jan2021; he experienced fever 102.5F; muscle and joint pain; muscle and joint pain; it hurts to raise his arms above his head; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient (Weight (kg): 79.38, height (cm): 170) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0140, Expiry Date: Mar2021), intramuscularly in upper left arm on 04Jan2021 13:00 for covid-19 prophylaxis. The patient had no relevant medical history and concomitant medications. Prior vaccinations (within 4 weeks) was none, relevant tests was none. The patient previous received first dose of Covid-19 Vaccine on 18Dec2020 and had no side effects, received flu vaccine in Oct2020 for immunization. The patient experienced fever 102.5f, muscle and joint pain, it hurts to raise his arms above his head all on 05Jan2021 01:00. The event was not required a visit to emergency room or physician office. The patient underwent lab tests and procedures which included fever: 102.5 F on 05Jan2021. Vaccination Facility Type was hospital. Caller stated that he worked at a hospital, but he was not a doctor, nurse, or pharmacist. The caller said that he received the second dose of Covid-19 vaccine 04Jan2021 and 12 hours after receiving the vaccine he started running a fever of 102.5. He said that he got the second dose at 13:00 and started feeling the fever symptoms about 12 hours later at about 01:00 05Jan2021. His vaccination was done at the hospital. He said that with his first dose he had no side effects. He received the first dose of the Covid-19 Vaccine on 18Dec2020. He said that he had his flu vaccine in Oct2020. Caller also reported that he was having muscle and joint pain. He said that it hurts to raise his arms above his head. He let his employee health know about the symptoms he was experiencing. Caller wanted to know if his side effects are normal, especially the "mild - moderate". The outcome of events was not resolved.
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| 57 | 2021-01-12 | pain in extremity |
arm sore; tired; This is a spontaneous report from a contactable consumer. A 57-year-old male patien...
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arm sore; tired; This is a spontaneous report from a contactable consumer. A 57-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration in the left arm on 28Dec2020 at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 28Dec2020, the patient experienced arm sore and tired a couple of days. No treatment was received for the adverse events. Outcome of the events was recovered on an unspecified date. The events were considered non-serious by the reporter. Information on the lot/batch number has been requested.
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| 57 | 2021-01-15 | pain in extremity |
24 hours after the second vaccine I had crushing, tightness in my chest. It felt like a myocardial i...
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24 hours after the second vaccine I had crushing, tightness in my chest. It felt like a myocardial infarction. It lasted 24 hours. I had difficulty doing my job. I considered going to the ER to rule out a myocardial infarction not related to the vaccine. I also had bone pain in right forearm and hand which lasted 24 hours. In addition, I had muscle pain in my entire upper body but not lower body. On day 2 I had right axillary swelling and pain.
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| 57 | 2021-01-16 | weakness |
3 days after receiving the first dose of the vaccine on 12/21/2020, experienced flu-like symptoms th...
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3 days after receiving the first dose of the vaccine on 12/21/2020, experienced flu-like symptoms that lasted 24 hours. About 17 hours after receiving the second does on 1/11/2021, flu-like symptoms reoccurred. The following day (1/13/2021) severe chills, and difficulty breathing occurred. Patient was admitted to Medical Center, where blood work, EKG, and oxygen were given and ordered. After overnight observation, the patient was discharged and informed that he had a severe reaction due to the Pfizer vaccine for Covid-19. As of 1/17/2021, patient still recovering and feeling generally weak and tired without much appetite.
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| 57 | 2021-01-18 | pain in extremity |
This morning it started all these different side effects and it's progressively getting worse, so I ...
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This morning it started all these different side effects and it's progressively getting worse, so I left work; Body aches; Headache; Stomach issues; pain; Diarrhea; Chills; Fever I just checked it's 102.4; Little sore arm at night; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received the 1st dose of bnt162b2 (BNT162B2, Batch/lot # EK9231) at single dose on 06Jan2021 around 2 O'clock for Covid-19 immunisation, administered ad hospital. Medical history included high cholesterol, hypertension, irregular heart beats, arrhythmia, acid reflux. Concomitant medication included amlodipine (AMLODIPINE) 10 mg once a day for hypertension, acetylsalicylic acid (BABY ASPIRIN) at 81 mg, once a day, carvedilol (CARVEDILOL) at 12.5 mg, two times a day hypertension, flecainide (FLECAINIDE) at 50 mg, twice a day for irregular heart beats, arrhythmia, olmesartan (OLMESARTAN) at 40 mg once a day for hypertension, omeprazole (OMEPRAZOLE) at 40 mg when needed for acid reflux, rosuvastatin (ROSUVASTATIN) at 20 mg, once a day for high cholesterol. The patient experienced little sore arm at night on 06Jan2021. Then, on 07Jan2021 morning he went in to work and it started all these different side effects and it's progressively getting worse, so he left work at abut 10 O' clock AM. He was getting body aches, headache, stomach issues, pain, diarrhea, chills, and fever I just checked it's 102.4 on 07Jan2021. The patient underwent lab tests physical examination with unknown results in Dec2020 3 weeks before this report (he had complete physical lab work with his doctor). Treatment included taking Tylenol and Advil. The outcome of all events was not recovered. Due date of second shot will be 23Jan2021.
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| 57 | 2021-01-20 | feeling cold, pain in extremity |
fever of 102, chills nausea, lack of appetite. fatigue .over 36 hours/ arm pain lasted for 4days///...
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fever of 102, chills nausea, lack of appetite. fatigue .over 36 hours/ arm pain lasted for 4days/// fever of 100 at 4am then fever of 102.2 at 5am, took medicine but temperature was consistent. struggle to get out of bed, only for restroom- also I was covid positive on 12-8-20 . Was recovered for approximately 2 weeks before I received the vaccine. Was told I could and should receive the vaccine.
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| 57 | 2021-01-23 | tremor |
Chills lead to severe shaking / seizure-like activity for approximately 1 hour. Condition abated af...
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Chills lead to severe shaking / seizure-like activity for approximately 1 hour. Condition abated after taking 1000 mg apap, 200 mg Motrin and 10 mg prednisone. This occurred about 12 hours post vaccine. Reaction preceded by brain fog.
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| 57 | 2021-01-26 | weakness | Covid 19 symtoms (cough, difficult to breath, tiredness and weakness. |
| 57 | 2021-01-26 | seizure like phenomena, unresponsive to stimuli |
Systemic: Exhaustion, Systemic: described by the EMT as a vasovegal reaction. patient passed out and...
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Systemic: Exhaustion, Systemic: described by the EMT as a vasovegal reaction. patient passed out and had seizure like reactions. was unresposive and given epi pen. after EMT arrived, patient was monitored and allowed to leave; symptoms lasted 1 day
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| 57 | 2021-01-27 | weakness, numbness, tingling |
Too large dose injected. Bolus was 1ml. Initial metallic taste and mouth 15 min after injection. Num...
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Too large dose injected. Bolus was 1ml. Initial metallic taste and mouth 15 min after injection. Numbness, tingling, muscular weakness in the left arm radiating to fingers along C7 dermatome. Severe fevers, chills, mental confusion, muscular weakness, exquisite tenderness at injection site, severe fatigue. Had to leave work. Slept 12 hours. Lingering muscular pain and fatigue for 48 hours following injection.
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| 57 | 2021-01-28 | tenderness |
Armpit lymph node swelling and tender after vaccine. Submandibular and neck lymph node also swollen ...
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Armpit lymph node swelling and tender after vaccine. Submandibular and neck lymph node also swollen on left side, persisting for several days.
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| 57 | 2021-02-01 | muscle spasms, weakness |
Near-syncope - lightheaded, generalized weakness, thigh cramps beginning around 15' post vaccination...
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Near-syncope - lightheaded, generalized weakness, thigh cramps beginning around 15' post vaccination Was placed supine, BP transiently elevated Pt transported to emergency dept. where he felt better, vitals normalized, observed In ED pt denied any focal weakness
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| 57 | 2021-02-03 | tenderness |
tennis ball size lump under left arm, only tender; tennis ball size lump under left arm, only tender...
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tennis ball size lump under left arm, only tender; tennis ball size lump under left arm, only tender; This is a spontaneous report from a contactable other hcp (patient). A 57-year-old male patient received first dose of BNT162B2 (lot number: EK9231), intramuscular on 16Jan2021 12:00 at single dose in the left arm for COVID-19 immunization. Medical history included allergies to penicillin and environmental. Concomitant medication included allopurinol. The patient experienced tennis ball size lump under left arm, only tender on 17Jan2021 23:00. The patient did not receive any treatment for the event. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the event was recovering.
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| 57 | 2021-02-04 | weakness |
weakness; chills; nausea; temp was 101.3/fever; swollen lymph nodes; This is a spontaneous report fr...
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weakness; chills; nausea; temp was 101.3/fever; swollen lymph nodes; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231), via an unspecified route of administration on left arm on 18Jan2021 19:45 at a single dose for COVID-19 immunization. The patient had no medical history. The patient had no known allergies. The patient received other vaccines within 4 weeks prior to the COVID vaccine including Whooping cough vaccine (Pertussis vaccine) on 11Dec2020 (dose number 1, left arm). On 19Jan2021 19:30, the patient had weakness, chills, nausea and his temperature (temp) was 101.3. He came home Wednesday from work at the 44th hour and had all symptoms "accept" (as reported) for swollen lymph nodes. Patient's fever broke 6 hours later at 22:00 (as reported) Wednesday night (on 20Jan2021, also reported as 50 hours after the injection), he slept all night comfortably, woke up with no issues and temp was 96.1 (21Jan2021). At the time of the report the patient felt fine. There was no treatment received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event fever was recovered on 20Jan2021 and other events recovered in Jan2021.
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| 57 | 2021-02-04 | migraine |
migraine type headache, severe at times dizzy, felt like head was in a tunnel and unable to clear it...
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migraine type headache, severe at times dizzy, felt like head was in a tunnel and unable to clear it; migraine type headache, severe at times dizzy, felt like head was in a tunnel and unable to clear it; migraine type headache, severe at times dizzy, felt like head was in a tunnel and unable to clear it; This is a spontaneous report from a contactable 57-year-old male other health care professional reported for himself. A 57-years-old male patient started to receive second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1284), via an unspecified route of administration at Left arm on 07Jan2021 at SINGLE DOSE for covid-19 immunization. Medical history included pinched nerve in left leg and kidney stones (recovered). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1685) Intramuscular at Left arm on 17Dec2020 04:00 PM for covid-19 immunization. The patient experienced migraine type headache, severe at times dizzy, felt like head was in a tunnel and unable to clear it. it had been going on since second dose and got worse, not sure if can continue work. The event started on 08Jan2021 02:00 AM, no treatment received for the adverse events. The events were reported as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No allergies to medications, food, or other products. The outcome of the event was not recovered.
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| 57 | 2021-02-04 | pain in extremity |
sore arm; headache; This is a spontaneous report from a contactable pharmacist reporting for self's ...
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sore arm; headache; This is a spontaneous report from a contactable pharmacist reporting for self's father. A 57-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number and expiration date unknown as not available/provided to reporter at the time of report completion), intramuscular at left arm on 20Jan2021 14:30 at single dose for COVID-19 immunization at a Nursing Home. The patient's medical history included hypertension and increased blood cholesterol. For concomitant medications, there was no other vaccine in four weeks. The father experienced sore arm and headache on 20Jan2021 after his first dose vaccination. He was scheduled for 2nd dose on 10Feb2021. Overall, the father was fine with the vaccine. Treatment was received for the events included Tylenol. The outcome of the events was recovered (in Jan2021). The father had no COVID-19 prior to the vaccination. The father had tested post vaccination, included COVID-19 virus test (Nasal Swab) on an unspecified date: Negative. Information on the lot/batch number has been requested.
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| 57 | 2021-02-05 | pain in extremity | Chills, strong pain in left arm and left shoulder, light headed, foggy thinking. |
| 57 | 2021-02-07 | weakness |
Stuffed nose, developed after 7 days; Nose became painful to touch; Light chills; light headache; la...
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Stuffed nose, developed after 7 days; Nose became painful to touch; Light chills; light headache; lack of strength; This is a spontaneous report from a contactable other hcp (patient himself). A 57-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection, lot no. EL1284, expiry date not reported), via an unspecified route of administration on 08Jan2021 12:00 at a single dose on right arm for covid-19 immunization. Medical history included hay fever. Prior to vaccination patient was not diagnosed with Covid-19. Concomitant medication included melatonin taken within 2 weeks of vaccination on unspecified date for unspecified indication. On 15Jan2021 (also reported as 17Jan2021-pending clarification), it was reported that patient had stuffed nose, developed after 7 days of vaccination. Nose became painful to touch. Light chills, light headache and lack of strength. Patient received treatment of TYLENOL and decongestant. Since the vaccination the patient has been tested for Covid-19. On 11Jan2021, patient had PCR and nasal swab, and both were negative. The facility where the most recent Covid-19 vaccine administered was in a hospital. The outcome of events was recovering.
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| 57 | 2021-02-10 | muscle spasms |
On January 8, I started having a cramping feeling in my right calf. It went on throughout the day ...
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On January 8, I started having a cramping feeling in my right calf. It went on throughout the day without a event. I woke up the next morning, and the crap was worse. I ran some errands and came home and then looked at my calf of my leg and it was twice the size as my other leg. I had four spots of bruising from ankle to knee. I immediately went to the emergency room. I was hospitalized and had bloodwork and an MRI done which showed that I had a DVT and a pulmonary embolus in my right lung. I was hospitalized for two days on blood thinners. I had no shortness of breath or heart problems during this time. I was then released from the hospital on blood thinners which I have to take for the next six months.
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| 57 | 2021-02-15 | facial paralysis, bell's palsy |
Onset of Bell's Palsy; facial drooping on left side, sore behind left ear and down left side of neck...
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Onset of Bell's Palsy; facial drooping on left side, sore behind left ear and down left side of neck Prednisone 20 mg 3 times per day for 7 days; Valacyclovir 1 g 3 times per day for 7 days; Eye is not as inflamed as it was previously; Patient and his wife feel that symptoms are drastically improving as of this report which is 4 days after the onset of the Bell's Palsy
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| 57 | 2021-02-19 | numbness | Numbness in the nose |
| 57 | 2021-02-21 | weakness, burning sensation, feeling hot, feeling of body temperature change, feeling of insects crawling on skin, pain in extremity |
Day after vaccine arm was very very sore, with a hard lump on arm at injection site. He states he fe...
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Day after vaccine arm was very very sore, with a hard lump on arm at injection site. He states he felt hot flashed and then cold flashes that continue to this day. States ' I feel like I have critters crawling up my skin starting at my legs and going through my body. Has headaches that start at the top of his head then pain radiates down the left side and then head feels very warm. At times he feels "like I am in a tunnel " and "everything slows down (mental/cognitive)" Continues s to this day to feel like there are "lumps within soft tissue areas on inner thigh, back and burning sensations. Chills on and off daily Exceptionally tired, no energy, feels drained. No changes in blood pressure
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| 57 | 2021-02-28 | muscle spasms |
This 57yo employee - reports he received his first Pfizer Covid vaccine on 1/13/2021 (Emergency resp...
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This 57yo employee - reports he received his first Pfizer Covid vaccine on 1/13/2021 (Emergency response provider). Approximately 3 hours post vaccination he c/o prickly stabbing itchy pain to vaccine site with left arm pain x 24 hours. He stated day 1 post vaccination the roof of his mouth, lips felt swollen and sensitive with a random frontal dull headache that lasted for a few seconds but noted on/off for 3 min duration a few times a day. He also reported a few days of altered sense of smell, especially to automotive products that has resolved. He states this prickly-itch stabbing pain varies all over his body, in his mouth, eyes, torso, extremities, again lasting a few seco
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| 57 | 2021-03-03 | weakness | Had fever headache, dizziness, week and tired ness |
| 57 | 2021-03-07 | muscle spasms, numbness, tingling |
Numbness and tingling down my left arm to my middle and ring finger; Numbness and tingling down my l...
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Numbness and tingling down my left arm to my middle and ring finger; Numbness and tingling down my left arm to my middle and ring finger; Occasional thoracic spasms; chills; This is a spontaneous report received from a contactable consumer (patient). A 57-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ELD26U, expiry date: unknown), via an unspecified route of administration in the left arm, on 05Feb2021 09:00, at single dose, for COVID-19 immunization, at a physician's office. The patient's medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3303, expiry date: unknown) received at 57 years of age, via an unspecified route of administration in the left arm, on 15Jan2021 10:45, at single dose, for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the BNT162B2 vaccine. On 06Feb2021 at 10:00, the patient experienced "numbness and tingling down my left arm to my middle and ring finger and occasional thoracic spasms and chills". It was unknown if treatment was provided. The outcome of the events was unknown. The reporter assessed the events as non-serious.
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| 57 | 2021-03-09 | slurring |
Miller Fisher syndrome, an acute inflammatory demyelinating polyneuropathy (GBS) variant. Acute ons...
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Miller Fisher syndrome, an acute inflammatory demyelinating polyneuropathy (GBS) variant. Acute onset of transient diplopia, and persistent dysarthria, ataxia, and areflexia starting approximately 1 week after vaccination. Patient was treated with IVIG, with good improvement in symptoms, allowing discharge home.
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| 57 | 2021-03-11 | feeling cold, cold sweat |
5 minutes after receiving immunization he became confused and foggy, complained of being faint, fogg...
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5 minutes after receiving immunization he became confused and foggy, complained of being faint, foggy, and having issues with his cognitive processing, he was also cool and clammy. He stated that he was feeling light headed and dizzy. He was monitored for about 5 more minutes in the pod and his symptoms continued . He brought back to the observation area, vital signs 119/78, oxygen 92% on room air and heart rate 63. He was given apple juice and applesauce and his mask removed, he was also placed on a liter. He was continued to be observed and follow up vital signs were 125/85, heart rate 66 @ 0849. Patient skin was less clammy and patient reporting symptoms improved. patient was able to move to sitting and standing position without any issues he was escorted to the site exit without incident.
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| 57 | 2021-03-11 | feeling cold |
Pfizer-BioNTech COVID-19 Vaccine EUA. On Friday morning, at 6-7am, less than 24 hours from the time...
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Pfizer-BioNTech COVID-19 Vaccine EUA. On Friday morning, at 6-7am, less than 24 hours from the time I received my vaccination, I was experiencing chills and could not get warm. I tried to go to work...well, I did go to work. When it became apparent that I was not going to get warm, I left work. When I got home, my wife made me breakfast between 8:30 & 9:00am. After i eat, I slept under a sheet and two blankets...fully dressed for 5 hours. When I came to, it was the first time all day that I felt some warmth.
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| 57 | 2021-03-11 | tingling, flushing |
tingling of tongue and feet, high spike in blood pressure (208/127), red flushed face and neck, dizz...
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tingling of tongue and feet, high spike in blood pressure (208/127), red flushed face and neck, dizziness and light headedness, increase in heart rate.
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| 57 | 2021-03-12 | weakness | Headache, muscle pain, weakness, tiredness, feverish feelings, general malaise |
| 57 | 2021-03-12 | feeling cold, weakness |
From Dose on Thur 11:30am, became extremely fatigued around hour 4. Hour 12 - I had on and off agai...
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From Dose on Thur 11:30am, became extremely fatigued around hour 4. Hour 12 - I had on and off again shivering chills for about 45 minutes. Hour 20 - I had sever body aches and overall weakness when I woke up the next day around 7-8am. The body aches continued for about 6-8 hours. The weakness continued for another few hours. No symptoms around hour 32 (7-8pm) on Friday.
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| 57 | 2021-03-12 | seizure | I experienced a seizure the next day...broke my foot during seizure |
| 57 | 2021-03-14 | flushing |
Experienced a delayed reaction to vaccine that occurred at 11 p. m. Administration was at 8:23 a. m...
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Experienced a delayed reaction to vaccine that occurred at 11 p. m. Administration was at 8:23 a. m. earlier in the day. Symptoms began as build up of mucous in back of throat and reflux. Very early the next morning symptoms progressed to near inability to swallow, Took 50 mg of Benadryl which gave a bit of relief. Very hard to drink the water and get it down with the two pills. The symptoms included swollen lips and inside of the mouth swelling. Went to the emergency room at the Clinic at 7:30 a. m. I was given 60 mg of Prednisone, Pepsid to coat the stomach re the steroids. Was sent home with prescription for epi pen, medrol dose pack, Pepsid and Zyrtec. Symptoms improved except for swelling of lips. However, on 3/11/21, despite taking the medication, the symptoms worsened in terms of renewed lip swell as well as new symptoms of facial flushing and chest flushing. Symptoms then abated with medication. On 3/13/21, symptoms flared again with renewed lip swelling, inside and outside check swelling and outside face and chest flushing. They they abated again with medication. On 3/14/21, lip swelling renewed as a symptom. To date, my lips do not feel right but tingly and bloated and irritated. Saw an allergist this morning who thinks I am allergic to polyglycol a preservative in the vaccine.
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| 57 | 2021-03-14 | tremor, feeling cold, depressed level of consciousness |
PRESENTING PROBLEM: Syncope and collapse [R55] HOSPITAL COURSE: History of Present Illness: 57-ye...
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PRESENTING PROBLEM: Syncope and collapse [R55] HOSPITAL COURSE: History of Present Illness: 57-year-old man known to me for bilateral lung transplant for bronchoalveolar cell carcinoma complicated by bilateral pleural effusions of unknown etiology and mild decrease in pulmonary mechanics, DVT on Eliquis who came to the Emergency Room 3/12/21 with a chief complaint of near syncope. Patient and woke up in the early morning hours of 3/12/21 to use the restroom. While urinating, he became very dizzy and nauseated and had a sense like he needed to lay down to rest. Other than nausea he did not have any other symptoms. He returned to his bed and fell upon his wife and had decreased level of consciousness but without total loss of consciousness (he was able to hear his wife talking to him but was unable to respond). This lasted about a minute and slowly he came back to his senses. After this he felt quite cold and did have some shaking but is not clear whether these were true rigors. He did not have any preceding fevers nor did he have any fevers in the emergency room. After about 5-10 minutes he was feeling back to his normal self but want to come into the hospital to get checked out. He has never had anything like this before.The patient has had chest pressure since his COVID vaccine which he had on Wednesday. This is been intermittent, mostly positional and better with laying on his side and leaning forward, worse with recumbency. It is not pleuritic in nature. No associated shortness of breath. No other fevers chills sweats. No sick contacts. Evaluation in the emergency room was done and a CT scan was done and no pulmonary embolus was found. No parenchymal abnormalities. The patient's pleural effusions remain, and her mildly worsened, personally reviewed. Baseline labs were unremarkable for anemia, kidney injury.EKG personally reviewed, normal sinus rhythm. High sensitivity troponin was done and negative. Family otherwise feels well, no sick contacts, eating well no nausea vomiting diarrhea blood in his stool. Pt admitted for observation. Continued to feel well VSS, ekg stable, ECHO without acute findings (see below), UA neg, cardiac monitoring uneventful, orthostatics negative, walking in halls and eating well. Appears to have had vaso vagal episode. Will be getting routine head imaging in the coming month with cancer history See below testing Care plan upon discharge > To call if any return of symptoms > To hold metformin until Monday due to recent dye load > Blood cultures Pending, low clinical suspicion > To change H2 blocker to PPI due to GERD on 3 month esophagram > Follow up in clinic when return from break > Dr discussing with pulmonary team most recent CT (see below) and treatment plan moving forward Brief exam: awake, alert, oriented, not in any distress. PERRL, EMOI, tongue midline. Upper and lower extremities at full strength 5/5 in the arms, hands, dorsi flex and flexion at the ankles, knees and legs. Sensation not tested. Brief history and medical decision making: s/p bilateral lung transplant for bronchoalveolar cell carcinoma complicated by bilateral loculated pleural effusion, DVT on eliquis presenting post syncopal event. Syncopal event without evidence of seizure like activity, fast recovery, and no sudden changes consistent with an acute cardiac event. Thus symptoms were likely due to vasovagal event possibly post COVID_19 related side effect (headache, achy muscles, not feeling well overall). He has no neurologic deficit, CTA thorax without PE, negative EKG, troponin and echocardiogram. He is not on antihypertensives and blood pressures have been normal. Given his initial diagnosis of BAC, there may be concern for metastatic disease, though symptoms have not persisted and he has no focal deficit. He also received contrast for his CTA today, thus will defer further imaging for now. Syncope: - defer 2nd dose of COVID-19 vaccine as its effectiveness in transplant patient is not established and patient potentially had an adverse event. - oral hydration encouraged - monitor for additional ongoing neurologic symptoms such as headaches, vision changes, neck stiffness, fevers, night sweats, weight loss, weakness or paraesthesias - patient advised to avoid driving until further evaluation - consider MRI brain with and without contrast if any symptoms persist or reoccur Complex loculated pleural effusion
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| 57 | 2021-03-16 | pain in extremity |
3/12/21 I began to experience soreness in both my legs. 3/13/21 I began to experience swelling in b...
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3/12/21 I began to experience soreness in both my legs. 3/13/21 I began to experience swelling in both my knees, but primarily in my left knee and leg. 3/14/21 I could barely bend my left knee, but there were no issues with my right knee. By 3/16/21 some of the swelling had gone down on my left knee. As of today 3/17/21 I still have some swelling in my left knee and lower leg.
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| 57 | 2021-03-18 | muscle spasms | Back muscle tighten/spasm 20 minutes after vaccination shot |
| 57 | 2021-03-19 | unresponsive to stimuli, seizure | Seizure (staring, unresponsive to verbal stimuli) started approx. 5 min post vaccination. |
| 57 | 2021-03-21 | feeling cold |
Fever - 101, chills and dizziness. Rotating Tylenol and Motrin every 6 hours. Was seen by primary c...
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Fever - 101, chills and dizziness. Rotating Tylenol and Motrin every 6 hours. Was seen by primary care physician.
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| 57 | 2021-03-21 | pain in extremity |
I had my first vaccine on the 3/9/2021 Pfizer - Biontech ENG199 and am scheduled to have the second ...
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I had my first vaccine on the 3/9/2021 Pfizer - Biontech ENG199 and am scheduled to have the second injection on the 3/30/2021 I had a slight arm pain 5 hours after the injection that wen away after 30 hours However on 3/15/2021 I had began to experience a stiff neck on the left side (I had the injection on the left side) Later on the evening of the 3/19/2021 I began to experience pressure in the left ear which is still persistant today. I really never had these issues before is this from the vaccine? What should I do?
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| 57 | 2021-03-22 | numbness |
Roof of mouth swelling, soft pallet swelling (@10 minutes),right side of upper scalp went numb (@20 ...
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Roof of mouth swelling, soft pallet swelling (@10 minutes),right side of upper scalp went numb (@20 mins) spreading to brow ridge -right side then spreading to left upper lip swelling (@30 mins). tongue and throat @40mins. Epipen given, swelling improved within a minute observed for 4 hours then released
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| 57 | 2021-03-22 | numbness and pain in extremities |
Joint pain; lower back pain; bowel issues; stomach issues; chills; severe neuropathy attack/both fee...
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Joint pain; lower back pain; bowel issues; stomach issues; chills; severe neuropathy attack/both feet were on fire when with proper medication, he has been under control for years; This is a spontaneous report from a contactable consumer. A 57-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date: unknown), via an unspecified route of administration in the left arm on 05Mar2021 at 15:45 at a single dose for COVID-19 immunization. Medical history included gout, neuropathy, high cholesterol and heart disease with 4 heart 'stints' and known allergies to dairy. Concomitant medications included colchicine (COLCHICINE), gabapentin (GABAPENTIN), acetylsalicylic acid (ASPRIN). The patient had no other vaccine in four weeks. The patient previously took and had allergies with Cipro [ciprofloxacin] and Erythromycin. It was reported that 20 hours plus after the shot, on 06Mar2021 at 13:15, the patient experienced the most severe neuropathy attack of his life - both feet were on fire when with proper medication, he has been under control for years. The patient also reported joint pain, lower back pain, bowel and stomach issues and chills on 06Mar2021 at 21:15. The patient had no COVID prior to the vaccination and had not tested post vaccination. No treatment administered for the events. The events had not resolved. Information on the lot/batch number has been requested.
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| 57 | 2021-03-23 | pain in extremity |
left arm soreness has continued since first immunization received on 2/14/2021, as well as since 2nd...
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left arm soreness has continued since first immunization received on 2/14/2021, as well as since 2nd immunization on 3/7/2021. Although mild in most positions, it is painful when I attempt to extend my arm laterally in an upward direction. The discomfort is mild under most circumstances, but is quite painful when, and only when, my arm is extended in the aforementioned manner. It has not required medication, and has not required me to seek medical attention. It has been persistent, and the severity has neither increased nor decreased. I've simply adjusted my range of motion to avoid those positions that elicit the pain. I would have expected the pain to gradually lessen, but it is not doing so. I suspect that there may be others experiencing the same side effect, so I want to report it.
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| 57 | 2021-03-24 | flushing, tingling |
Hives appeared about 15 minutes after injection - tingly & slightly itchy skin, feeling flush, hands...
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Hives appeared about 15 minutes after injection - tingly & slightly itchy skin, feeling flush, hands slightly red. Symptoms lasted about 24 hours.
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| 57 | 2021-03-24 | muscle spasms |
Symptoms started with frequent urination night of receiving vaccine(got up at least 4-5 times in the...
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Symptoms started with frequent urination night of receiving vaccine(got up at least 4-5 times in the middle of the night to pee, felt like I couldnt get it all out.), cramping in the bladder area, blood in the urine(pink urine). Little cramping but not urinating blood for now Drank a lot of water and went away This more than likely unrelated. The next step you would need to take is to go to your primary care physician to get checked, if you have any updates on this please give us a call.
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| 57 | 2021-03-24 | pain in extremity |
Arm hurt really bad; Little bit of fever; Little bit of body aches; vitamin D deficiency; stage 4 ch...
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Arm hurt really bad; Little bit of fever; Little bit of body aches; vitamin D deficiency; stage 4 chronic kidney disease; This is a spontaneous report from a contactable consumer. A 57-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose at the age of 57-years-old via an unspecified route of administration, administered in arm left on 23Feb2021 10:30 (Batch/Lot Number: EL9267, expiry date not reported) as single dose for covid-19 immunisation. Medical history included ongoing diabetic, heart patient from 2005 and ongoing, cardiomyopathy from 2005 and ongoing, covid-19 from 14Jan2021 to an unknown date. The patient's concomitant medications were not reported. The reporter reported that her husband (patient) was diagnosed 2 days ago with a vitamin D deficiency and diagnosed at the end of last week with stage 4 chronic kidney disease. The patient just started on his Vitamin D pill until yesterday. He didn't know he was lacking Vitamin D until the doctor found out. She wants to know if her husband should go ahead and get the second vaccine tomorrow or should he wait a week and let the Vitamin D pill kick in. It was also reported that the patient's arm started hurting about 5 or 6 hours later after getting the shot on 23Feb2021. The next day, it felt really bad. The patient also had a little bit of fever and body aches on 23Feb2021. The patient had a bunch of labs done and is going back again on 25Mar2021 to have another extensive tests done. It was clarified that it was for the chronic kidney disease and this was also when he found out he had the vitamin D Deficiency. The patient is also getting an ultrasound done on his kidneys to see what is going on. Therapeutic measure were taken as a result of vitamin D deficiency which included treatment with vitamin D pill and for little bit of fever and body aches which included Tylenol PM. The patient did not recover from stage 4 chronic kidney disease and vitamin D deficiency, recovered from arm hurt really bad and little bit of body aches on 25Feb2021, a little bit of fever on 24Feb2021.
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| 57 | 2021-03-26 | weakness |
Nausea with slight chills and sweating the next morning. Fatigue and low energy with body aches for...
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Nausea with slight chills and sweating the next morning. Fatigue and low energy with body aches for 12-16 hours after.
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| 57 | 2021-03-26 | tremor |
Dizziness. Severe at times, especially when moving. Nausea. Weakness, very shaky. Onsite nurses an...
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Dizziness. Severe at times, especially when moving. Nausea. Weakness, very shaky. Onsite nurses and doctor gave me water, peanut butter crackers, and a juice box. No change. BP elevated, 157/109 p:98 O2s: 99 on site. Transferred to the Hospital via ambulance. After 2-3 hours, dizziness began to resolve. Doctor ordered blood tests and IV fluids, 1L.
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| 57 | 2021-03-29 | feeling hot |
is a 57 y.o. male who received the Pfizer-BioNtech Covid-19 Vaccine, mRNA, BNT162b2 (PF) 30 mcg/0.3 ...
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is a 57 y.o. male who received the Pfizer-BioNtech Covid-19 Vaccine, mRNA, BNT162b2 (PF) 30 mcg/0.3 mL IM Susp, Lot ER8734 on 3/30/2021. The patient experienced the following reaction(s) during the immediate of observation: PT reports feeling "warm" Patient was treated/managed as follows: Vitals were taken and are as follows: 1249: BP- 132/84 HR: 54 RR 18 O2 sat- 97% RA Pt reports symptoms are the same. Water offered. VS retaken 1300: BP- 128/82 HR: 54 RR: 18 O2: 98% Patient given educational material regarding vaccine and advised to continue to self-monitor per the CDC guidance. Pt escorted to car at 1308 by wife.
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| 57 | 2021-03-29 | pain in extremity |
Arm pain immediately at injection. Whole arm to fingers. Bad metallic taste in mouth. Water also ...
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Arm pain immediately at injection. Whole arm to fingers. Bad metallic taste in mouth. Water also tastes different. Arm pain is moderate to accute. Not resolved 6 hrs post vaccine.
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| 57 | 2021-03-29 | pain in extremity |
After both doses, I could not sleep well the night after. I had no other adverse reactions, other th...
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After both doses, I could not sleep well the night after. I had no other adverse reactions, other that a sore arm.
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| 57 | 2021-03-29 | tingling |
Client stated that the injection of the vaccine stung and shortly after his arm began to itch and fe...
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Client stated that the injection of the vaccine stung and shortly after his arm began to itch and feel tingly. Nurse applied an ice pack to site and gave client 25mg benadryl the injection site was also red at this time. About 5 min after Benadryl was taken, client stated that itchiness had improved. Denied shortness of breath, and dizziness. Nurse observed that redness of site was improved. Client released to leave via personal vehicle by RN.
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| 57 | 2021-03-29 | tenderness |
Persistent sore throat, right side, not inside esophagus, tender/sore when swallow and when pressed,...
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Persistent sore throat, right side, not inside esophagus, tender/sore when swallow and when pressed, lymph node area Tylenol little effect
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| 57 | 2021-03-29 | unresponsive to stimuli |
Per ED Provider Report, the patient collapsed while outside on 3/25/21. Ambulance was called to the ...
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Per ED Provider Report, the patient collapsed while outside on 3/25/21. Ambulance was called to the scene where patient was found unresponsive. Patient was transferred to Hospital. Patient was in full cardiac arrest upon arrival. CPR was initiated. Patient deceased. Patient's mother stated the patient had been feeling badly for 2-days, but refused to seek medical treatment.
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| 57 | 2021-03-30 | cold sweat, weakness |
Patient felt dizzy and felt like passing out. V.S. taken Pulse 42, became clammy, diaphoretic, and v...
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Patient felt dizzy and felt like passing out. V.S. taken Pulse 42, became clammy, diaphoretic, and very weak. Rapid Response called, patient to the Emergency Room.
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| 57 | 2021-03-31 | pain in extremity |
Blood clot/very large blood clot from his thigh to his calf; Joint pain; chills; he can't even walk ...
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Blood clot/very large blood clot from his thigh to his calf; Joint pain; chills; he can't even walk now; leg pain; This is a spontaneous report received from a contactable consumer (patient's wife). A 57-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN6202), via an unspecified route of administration, on 25Feb2021 (at the age of 57-years-old), at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The consumer stated she's asking on behalf of her husband. He received his first dose of Pfizer-BioNTech COVID-19 Vaccine on 25Feb2021 and had Joint pain and chills after that (on unspecified date in 2021) he was diagnosed with Blood clot (unspecified date in 2021); she stated he had no history of similar health issues and wanted to know if it could be directly linked to this vaccine. The wife further reported that it's dramatically changing his life, he can't even walk now. He had the Covid vaccine on 25Feb2021 and he has no history of blood clots. He developed a leg pain (on unspecified date in 2021) which was odd and they thought that maybe it was some arthritis or something like that. They went to the orthopedist and he was being treated for what the orthopedist thought was a bakers cyst. But then they discovered it was a very large blood clot from his thigh to his calf. They would like to know about this. They have been looking into what he had experienced, and it seems very unusual. It just seems too coincidental that this happened after the Covid vaccine. The emergency room doctor of course shut them down immediately and said that the Covid vaccine never would have done this. But the patient's doctor yesterday said that there are too many unknowns to say for sure that the Covid vaccine didn't cause this. She is not saying that they are against the Covid vaccine, but they are concerned. The patient is on blood thinners now and they just need to know if there is a possible correlation. She had heard on the world news that there is a connection after receiving the (company name) Covid vaccine and now they are shutting this vaccine down in (region name). She saw on the news last night they were asking if there is a correlation with the Pfizer and (company name) Covid vaccines and this. It is very concerning. They have been trying to do research and there is nothing that you can find. The only thing that they did see online was about the doctor that died of a blood disorder in (state name), he had thrombocytopenia. The patient is going to be sent to see a vein doctor. She stated that he has a lot of things ahead of him and he is too young to be dealing with all of this. They are going to be following up with the vein doctor and she would like to have this information when the vein doctor calls later today. The reported adverse events resulted to an emergency room and physician office visit (went to the orthopedist). The patient received corrective treatment as response to the reported events. Outcome of the events was unknown.
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| 57 | 2021-04-01 | muscle spasms |
My Husband has a swollen lymph node on his left armpit the size of a golf ball or larger. He is expe...
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My Husband has a swollen lymph node on his left armpit the size of a golf ball or larger. He is experiencing cramping all over his body but especially his legs. He has a terrible headache, feels nautious and dizzy. Today has been the worst. This is day 3 after the Pfizer shot. The internet says it is normal for the lymph node in about 14% of patients. Your flyer handed out at injection day didn't mention all of this.
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| 57 | 2021-04-01 | night sweats | headache, sore muscles, chills, night sweats for approx 24 hrs |
| 57 | 2021-04-01 | pain in extremity |
vaccine was administered on Monday afternoon. arm soreness started Monday evening. symptoms: arm sor...
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vaccine was administered on Monday afternoon. arm soreness started Monday evening. symptoms: arm soreness, full body aches, chills, fever of 102, lymph nodes swollen the size of a racquetball, headache. all symptoms peaked in severity on Wednesday. improved on Thursday. resolved by Friday.
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| 57 | 2021-04-01 | seizure |
patient was in 15 minute observation when nurses witnessed patient seizing. patient was on floor, p...
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patient was in 15 minute observation when nurses witnessed patient seizing. patient was on floor, pulse and respiration was monitored. pulse diminished ; oxygen was administrated, CPR started AED applied patient shocked and transported to ER
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| 57 | 2021-04-02 | inability to speak |
Lethargy, erythema at site, fever to 104.2, loss of ability to stand or walk, confusion, reduction i...
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Lethargy, erythema at site, fever to 104.2, loss of ability to stand or walk, confusion, reduction in speech ability. Symptoms started during the evening of 3/30/21 after vaccination. PCP was contacted on 3/31/21 and we were told the effects would only last 48 hours. Fever was reduced with Acetaminophen 1000 mg q6h x 2 doses, oral fluids, and icing the axillary. 911 was called on 4/1/21 when pt lost ability to stand and and was minimally vocal but alert. Pt was hospitalized and remains in that situation at this time.
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| 57 | 2021-04-02 | flushing |
a few minutes after injection patient began to feel flush in the face, soon followed by hives neck, ...
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a few minutes after injection patient began to feel flush in the face, soon followed by hives neck, chest, abd. complained at that time of tight breathing, epipen delivered and patient further observed by ems
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| 57 | 2021-04-02 | numbness, tingling |
Facial numbness and tingling in addition to lip and tongue swelling. Left eyelid became droopy. Swel...
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Facial numbness and tingling in addition to lip and tongue swelling. Left eyelid became droopy. Swelling did not obstruct airway.
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| 57 | 2021-04-02 | night sweats |
Ive had significant night sweats waking up with the bed and sheets soaked and subsequent feeling col...
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Ive had significant night sweats waking up with the bed and sheets soaked and subsequent feeling cold from the wet bed. I have not monitored completely but it seems I?ve had some degree of this sequelae in varying degree of sweating every night for the week since I was vaccinated. I don?t feel sick but feel slightly more tired than usual. I cycle on average 5-6 days a week riding 15 miles a day. On off days I walk for 3 miles. My health is generally good.
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| 57 | 2021-04-04 | bell's palsy, face paralysis, facial paralysis |
Patient reports Bell's Palsy in face following vaccination. Has continued for days since vaccine and...
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Patient reports Bell's Palsy in face following vaccination. Has continued for days since vaccine and was still unresolved as of Thursday 4/1/2021. Unsure at this point if resolved. Reports facial weakness and drooping.
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| 57 | 2021-04-06 | facial paralysis, slurring, numbness |
About 7 - 8 days after the vaccination, the patient began experiencing numbness in his chin that cam...
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About 7 - 8 days after the vaccination, the patient began experiencing numbness in his chin that came and went. By Friday, April 2, the patient began experiencing left side numbness and droopiness in his face, had slurred speech and increased blood pressure. Patient thought he was having a stroke, so wife took him to the ER. All lab work and medical tests came back normal. The patient has an appointment with their family doctor on 4/8 and an appointment with a neurologist next month.
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| 57 | 2021-04-06 | pain in extremity | Pain, swelling, and redness right calf for 2 days. Diagnosed with acute DVT. |
| 57 | 2021-04-06 | tingling |
Paresthesia within a minute, but only in right fingers at first. Then within the hour the left fin...
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Paresthesia within a minute, but only in right fingers at first. Then within the hour the left fingers had the effect. This sensation went on and off for about 5 days and after the first day began to include both feet. After a week it seemed to resolve, however, at the 2 weeks and 1 day point, paresthesia returned stronger, in both hands and forearms, both feet and lower leg starting at around 12:30pm on 4/7/21. It continues at this writing which is 9:00pm on 4/7/21. The sensation is more severe than the first week and not intermittent this time.
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| 57 | 2021-04-06 | tingling |
Stomach felt queesy and then my face began to tingle and feel very strange. This lasted about 2 hou...
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Stomach felt queesy and then my face began to tingle and feel very strange. This lasted about 2 hours and then went away. I went to bed and slept it off and have not had any other affects.
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| 57 | 2021-04-07 | flushing |
After receiving the vaccine and waiting the 15min, I left the vaccination site and headed home in my...
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After receiving the vaccine and waiting the 15min, I left the vaccination site and headed home in my vehicle. After about 10 to 15 mins I encountered a metallic taste in my mouth and my mouth almost felt as though it was vibrating almost like a surging feeling. I then became flushed in the face and my tongue felt odd as if it was swelling. My throat became dry. I waiting five more minutes and decided to take the next exit off of I87 and drove directly to a urgent care center. Upon arrival I sat in my car for 20 more minutes to see if my symptoms would pass and they did. I did not need to enter into the urgent care facility. I have not had any other symptoms since this event.
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| 57 | 2021-04-07 | flushing |
Rash, itching, hives. Started in groin area, then moved to triceps, then on both sides of trunk, th...
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Rash, itching, hives. Started in groin area, then moved to triceps, then on both sides of trunk, then behind knees. Redness and flushing of face but no swelling/rash/hives/itching. As rash has subsided, low grade fever came on (100 degrees F).
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| 57 | 2021-04-07 | muscle spasms |
Adverse events I?m all pissed off. cramps all over my body legs arms hands both sides of my rib cage...
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Adverse events I?m all pissed off. cramps all over my body legs arms hands both sides of my rib cage neck I?m sick fatigued the runs just yesterday and Today
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| 57 | 2021-04-07 | tingling |
all body tingling, foggy mind, unable to fully focus eyes, SOB and pain in lungs. Gave benadryl 25mg...
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all body tingling, foggy mind, unable to fully focus eyes, SOB and pain in lungs. Gave benadryl 25mg. and monitored. Resolved 70 minutes following start.
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| 57 | 2021-04-08 | feeling hot |
Redness, slight-swelling, warmth, and pain in left knee. No previous injury, diagnosed RA, or other...
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Redness, slight-swelling, warmth, and pain in left knee. No previous injury, diagnosed RA, or other known issue with left knee. Mentioned to physician during routine check-up, but he made no recommendations. Knee no longer swollen, red, or warm, but is tender when pressure is applied.
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| 57 | 2021-04-09 | pain in extremity | pain in left leg calf, left side of chest DVT and PE 2 visits to Urgent Care Lovenox and Pradaxa |
| 57 | 2021-04-09 | pain in extremity |
Sore Left Arm day/night of injection resolved next day Extreme Fatigue day of and next day after in...
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Sore Left Arm day/night of injection resolved next day Extreme Fatigue day of and next day after injection resolved third day
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| 57 | 2021-04-09 | tingling |
Fever (103) and chills for 12 hours, myalgia (arms, shoulders, gluts, quads), arthralgia and parasth...
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Fever (103) and chills for 12 hours, myalgia (arms, shoulders, gluts, quads), arthralgia and parasthesia in right hand.
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| 57 | 2021-04-10 | discomfort, weakness | Low grade fever Significant body discomfort Weakness |
| 57 | 2021-04-11 | feeling cold | Fever, body aches,cold chills |
| 57 | 2021-04-12 | burning sensation, pain in extremity |
I had my first Covid vaccine (Pfizer - Lot ER2613) on March 17. No issues other than a soar arm the...
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I had my first Covid vaccine (Pfizer - Lot ER2613) on March 17. No issues other than a soar arm the next day. In fact, I went on a hard 7 mile run the next day as part of my normal training routine (currently training for a half Marathon.) This past Thursday, April 8, at 6:00 pm EST, I had my 2nd shot (Lot EW0161). For about the next 18 hours, I was fine other than the arm being a little sore in the morning. Late in the morning I noticed my back was getting very stiff and a bit sore when I moved around. I have a desk job and spend a lot of time in front of the computer, but I normally stretch and move throughout most days, so I don?t have many back issues. This was a bit worse than normal. Usually, when I feel something like this, my go to remedy is an easy run. I had a 5 mile easy run planned for that day, so later in the afternoon, after some dynamic stretching, I went for a run. As I started, I felt some of the worse back pain I could remember and stopped running after about 50 yards. I stretched a little more, questioning if I should continue, but decided that movement would be better than doing nothing. I started running again and although the first mile was much more uncomfortable and painful than normal, I continued on for the 5 miles with everything eventually loosening up as the blood starting flowing. I felt pretty good the rest of the day and into the evening. In the middle of the night, I awoke numerous times with a bad ache in my back, which is very unusual for me. I tossed and turned all night from side to side, from front to back but could not stop the burn and pain in my lower back. I took 2 Advil, but that did little to help. I got out of bed about an hour earlier than normal and after a little light stretching, my back felt fine again. I went for my weekly long 14 mile run an hour later and everything was good again and for the rest of the day. The next 3 days / nights have been similar. I continue waking each night with a burning and aching in my lower back and it continues all night long. Once I stand up, get out of bed and start moving around, the pain and burning go away almost immediately. I?ve never felt anything like this before. I?m 57, male, am very healthy and fit (aiming for a 1:30 half marathon in 10 days.) Never had issues with sleeping before this and haven?t experienced any back pain in a very long time. I can?t think of anything I?ve done recently to trigger this other than the coincidence of the 2nd Pfizer vaccine shot.
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| 57 | 2021-04-12 | feeling cold |
My face and lips feel frozen. This has been ongoing since the evening of the vaccination. The best...
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My face and lips feel frozen. This has been ongoing since the evening of the vaccination. The best way to describe the feeling is that it feels like your face feels when you put soap on it before you rinse it off...it feels tight.
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| 57 | 2021-04-12 | tingling |
Woke up in the middle of the night twice with Tingling in my finger tips even though I was sleeping...
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Woke up in the middle of the night twice with Tingling in my finger tips even though I was sleeping on my back and not having any pressure on my arms like you would normally experience if your arm fell asleep? This happened again last night . After waking and moving my hands and fingers the tingling stopped.
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| 57 | 2021-04-13 | pain in extremity, tingling |
*Pfizer-BioNTech COVID-19 vACCINE eua, Patient complained of pain and tingling starting 7 days post...
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*Pfizer-BioNTech COVID-19 vACCINE eua, Patient complained of pain and tingling starting 7 days post vaccination from the knees down to the bottom of the feet. The pain and tingling in his feet is most severe. The pain wakes him up at night during sleep to the point that he is unable to fall back asleep, and the pain and tingling is still there when he wakes . The tingling and pain is not noticeable once the patient is working, and once he wakes he still has the symptoms, but it is not as bad as it is during the night. He had not experienced this pain or tingling ever before having the vaccination.
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| 57 | 2021-04-13 | tingling, numbness |
Blood Clot-Bad swelling in right arm. Arm tingling, numbness and discolored. Arm is swollen from top...
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Blood Clot-Bad swelling in right arm. Arm tingling, numbness and discolored. Arm is swollen from top of arm to fingers. Notice first sign on Monday morning (04/12/2021) when i awoke from bed around 7:00am.
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| 57 | 2021-04-15 | facial paralysis, bell's palsy |
Developed right facial eyebrow sagging, inability to close eye, disappearance nasolabial fold, droop...
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Developed right facial eyebrow sagging, inability to close eye, disappearance nasolabial fold, drooping corner mouth, and decreased tearing; onset 4/8/21; diagnosed with right Bells Palsy
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| 57 | 2021-04-15 | numbness |
Several hours after receiving the 2nd shot I notice the right side of my mouth, lip, and down toward...
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Several hours after receiving the 2nd shot I notice the right side of my mouth, lip, and down towards my chin started feeling numb. I thought prehaps the next day or 2 my feeling would return and the numbness would be gone. It's now 4/16/21 and the numbness is still there.
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| 57 | 2021-04-16 | weakness |
Fever, headache, body aches, joint aches, weakness, chills. abdomen pain, severe trembling. Had sho...
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Fever, headache, body aches, joint aches, weakness, chills. abdomen pain, severe trembling. Had shot at 4:30pm, woke up the next morning at 6 am and symptoms were there. They got worse during the day. Had issues getting fever down. In the evening was able to break fever and was able to eat. Now second day since injection only have a headache and fatigue.
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| 57 | 2021-04-17 | inability to speak |
Pt developed fever as high as 104.2; confusion, inability to form sentences; restlessness; inability...
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Pt developed fever as high as 104.2; confusion, inability to form sentences; restlessness; inability to ambulate.; inability to form sentence; This is a spontaneous report from a contactable nurse. A 57-year-old male patient received the first dose of BNT162B2 (lot no. and expiry date were unknown), via an unspecified route of administration, administered in right arm on 30Mar2021 (at the age of 57-year-old) as single dose for COVID-19 immunization. Medical history included Cancer Stage 4 - renal with mets. The patient's concomitant medications were not reported. The patient previously took ciprofloxacin (CIPRO) and sulfamethoxazole, trimethoprim (BACTRIM) in which he experienced allergies to both drugs. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Mar2021, the patient developed fever as high as 104.2, confusion, inability to form sentences, restlessness, and inability to ambulate. He was hospitalized on unspecified date due to the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient had nasal swab on 01Apr2021 with negative result. The outcome of the events was not recovered. Information on lot/batch number has been requested.; Sender's Comments: The information currently available is extremely limited and does not allow a meaningful case assessment. However, based solely on an implied temporal association, a causal relationship between events fever,confusion,aphasia,movementdisorder adverse events and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The case will be reevaluated should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified.
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| 57 | 2021-04-18 | weakness, cold extremities |
Immediately upon being vaccinated, the patient felt weak, tachycardic, and had chills and nausea. He...
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Immediately upon being vaccinated, the patient felt weak, tachycardic, and had chills and nausea. He was observed for 20 minutes, at which time his symptoms abated and he left the vaccination facility. However, his symptoms returned later in the day. He presented to our office 15 days after vaccination. At that point, he was suffering coldness in his extremities with peripheral cyanosis of hands, feet, and nose. He reported chest pain and had an abnormal EKG with ST depressions in several leads. He stated that over the past two weeks, his symptoms would come and go, lasting for hours at a time and constituting weakness, extreme fatigue, cold extremities, and body aches.
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| 57 | 2021-04-18 | discomfort |
Started with a bad headache that wouldn't go away. Then heavy pressure over my eyes, and feeling ver...
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Started with a bad headache that wouldn't go away. Then heavy pressure over my eyes, and feeling very tired. Symptoms went away for a few days, then returned. Got tested for COVID-19, with a PCR lab test, and the results were positive.
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| 57 | 2021-04-18 | facial paralysis |
Had a blood clot and a stroke and blind in right eye, and some paralysis in face. Happened day after...
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Had a blood clot and a stroke and blind in right eye, and some paralysis in face. Happened day after first vaccine.
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| 57 | 2021-04-19 | cold sweat |
After 8 minutes I broke out in a cold sweat and immediately passed out for 30-45 seconds. I woke up ...
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After 8 minutes I broke out in a cold sweat and immediately passed out for 30-45 seconds. I woke up laying on my back not knowing how I got there.
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| 57 | 2021-04-20 | bell's palsy |
Bell's Palsy; This is a spontaneous report from a contactable consumer. A 57-year-old male patient r...
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Bell's Palsy; This is a spontaneous report from a contactable consumer. A 57-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 23Mar2021 01:30 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included ADHD, depression, High Blood Pressure, high cholesterol, Allergies to medications, food, or other products:Penicillin. Concomitant medications included losartan (LOSARTAN); paroxetine hydrochloride (PAXIL CR); atorvastatin calcium (LIPITOR [ATORVASTATIN CALCIUM]); amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); all taken for unspecified indications, start and stop dates were not reported. On 04Apr2021 12:00, the patient experienced Bell's Palsy. The patient did not receive treatment for the event. The outcome of the event was not recovered. Information about batch/lot number has been requested.
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| 57 | 2021-04-20 | discomfort |
Slight discomfort in left arm injection site by 6PM and went to bed 9:30PM. Woke up 12:30AM with ch...
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Slight discomfort in left arm injection site by 6PM and went to bed 9:30PM. Woke up 12:30AM with chills and did not sleep well for the remainder of night. Got up 5:30AM ate something and had some coffee. What was noticeable initially was fatigue, followed by chills. My temperature was 99.2 and 99.4. I never took any medication until going to bed. I reported in sick to work and went back to bed for 4 hours approximately. I felt bad all day even as I went to bed.(chills and very fatigued). I tried to keep very warm and took Tylenol PM to sleep. 100% recovery 1 day later
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| 57 | 2021-04-20 | pain in extremity |
Severe Flare-up of joint pain in ankles, knees, shoulders, elbows, wrist, & hands. Treating with pr...
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Severe Flare-up of joint pain in ankles, knees, shoulders, elbows, wrist, & hands. Treating with prednisone 5mg tablet daily and at night before bed, also Equate 8 hr arthritus pain relief, 650mg, 1 tablet up to twice a day.
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| 57 | 2021-04-20 | tingling, numbness |
patient received Pfizer covid vaccine on 4/12. On 4/13 patient presented to ER with purple fingers ...
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patient received Pfizer covid vaccine on 4/12. On 4/13 patient presented to ER with purple fingers and toes. bilateral feet numb and tingling. patient admitted to hospital. by morning 4/14 patien resp status declined, ciwa score 15, afib rvr, ams, low bp. septic shock. source unclear.
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| 57 | 2021-04-21 | feeling cold | Severe cold chills, headache, entire body is sore |
| 57 | 2021-04-21 | flushing |
1545 TO NSG DESK POST INJECTION. COMPLAIN OF FEELING FLUSHED AND LIGHT HEADED. PT ASSISTED TO STRETC...
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1545 TO NSG DESK POST INJECTION. COMPLAIN OF FEELING FLUSHED AND LIGHT HEADED. PT ASSISTED TO STRETCHER.BP 143/110 HR 134 DENIES SOB, NO RASH NOTED. PT WITH NO OTHER COMPLAINTS 1550 BP 156/92 HR 140, ENCOURAGED TO RELAX. NO RAPID BREATHING, DENIES SOB. 1555 BP 154/94 HR 130 1558 BP 152/98 HR 142 1607 BP 141/89 HR 115 EMS HERE SO AT BEDSIDE TO AMBULANCE VIA STRETCHER
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| 57 | 2021-04-21 | pain in extremity | Sore arm into armpit and sharp headaches(off and on for a week) |
| 57 | 2021-04-23 | coordination abnormal, weakness |
My left arm and shoulder, where shot was given, is very weak and uncoordinated. I am now getting ti...
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My left arm and shoulder, where shot was given, is very weak and uncoordinated. I am now getting tingling/numb sensations. This started one day after shot, and conditions have existed for 3 weeks.
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| 57 | 2021-04-23 | flushing |
On 4/8 felt flush and very tired. On 4/9 developed a large sore on my tongue that was very painful u...
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On 4/8 felt flush and very tired. On 4/9 developed a large sore on my tongue that was very painful until 4/12. Continued to be tired until 4/15.
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| 57 | 2021-04-24 | pain in extremity, night sweats |
This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient recei...
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This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247 and expiration date not provided), via an unspecified route of administration, on 06Apr2021 10:30 (at the age of 57-year-old), at single dose, for COVID-19 immunization. Medical history included chronic obstructive pulmonary disease (COPD) from 2018 and ongoing, and had a shot, a steroid for COPD; high blood pressure from 2016 and ongoing, and patient took medication for it; 7 heart attacks; 8 stents in his heart; patient was a smoker (ongoing, had been smoking for a long time. He was a walking post card for don't smoke. He stated that he can only walk twenty feet before he was out of breath); and patient was allergic to penicillin and Lortab. Family history included patient had a family member die of cancer and lupus. Patient had two biopsies for skin cancer (unknown date) within 4 weeks prior vaccinations. Concomitant medications were not reported. On 07Apr2021, the patient experienced extremely high blood pressure, arm aching, body aches, night sweats, and headaches. The patient stated since receiving the vaccine, that his blood pressure was very high and his medications were not bring it down. He stated that one of his blood pressures was 197/121 and this morning it was 181/130, which was extremely high for him. He stated that he went through the aches and his arm was hurting. He even had sweats last night. Patient stated that his blood pressure still hadn't come down and he could feel headache from the pressure. He stated he already called the doctor, and the doctor told him that if it persisted to go to the emergency room. He stated that he took a couple of medications for his blood pressure and he declined giving medication information. He said that one started with an R and he took another one twice a day. He said that all the names of them, remembering them at his age was hard. He stated that he could read that small writing he had to get a magnifying glasses. Patient was scheduled for next vaccine on 04May2021. He stated that his blood pressure was not so unbearable but it was pretty high, he checked his blood pressure twice a day for everyday. He stated whatever he was lucky if he remembers if he had breakfast in the morning, until he remembered that he hadn't had breakfast. He stated that his arm started aching on 07Apr2021, it had improved but was still ongoing. He stated that it felt pretty good. Patient's blood pressure had been constant since today was the 8th it's only been a little over 24 hours now. On 07Apr2021 he had night sweats. He woke up pillow was soaking wet. He stated that his body aches still ongoing started about the same time. His headache started at the same time and was still going on. Patient stated he had a heart attack in 2016 and he hadn't had a normal blood pressure since. He hadn't been able to keep it all in check since the vaccine. His blood pressure medicine had been changed from 20 mgs to 40 mgs. He was under constant doctor care. The patient underwent lab tests and procedures, which included blood pressure was 197/121 (unknown date), 181/130 (08Apr2021), and 165/116 (08Apr2021). Patient's heart rate was 85 (unknown date). Patient stated his normal blood pressure was 135/85, his normal heart rate was 75. The outcome of the events "extremely high blood pressure", "body aches", "headaches" was not recovered; of event "arm aching" was recovering; of other events was unknown. No follow-up attempts are needed. No further information is expected.
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| 57 | 2021-04-25 | burning sensation |
Patient received first dose of the Pfizer Covid19 vaccine on Wednesday 4/21/21 at 0858. He stated th...
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Patient received first dose of the Pfizer Covid19 vaccine on Wednesday 4/21/21 at 0858. He stated that on Thursday 4/22/21 his feet began to itch. He also reported that his hands started to have small red bumps which did not really itch. Patient reported that by Saturday the rash had spread to cover his entire foot to include his toes and heels. He stated he feet began to burn. He also stated the rash to his hands got worse; minor itching to the areas. Seen on 04/26/21 at 11:28 am. On exam today patient's rash is not blanchable. He has rash like areas to his upper and lower legs, hands, upper arms, feet. The rash is different in appearance- some areas are round red circles with a white center, some areas are thick red patches, and some areas are small red bumps. Patient reports that areas that experience friction itch more (like the tops of his feet from rubbing on his shoes). Patient given 50 mg diphenhydramine (oral) at 12:00 pm. At 1:50 pm patient reports the itching has lessened with the medication but does not wish to continue to take. Have noted adverse reaction in patient's medical record.
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| 57 | 2021-04-25 | pain in extremity |
Fatigue, fever of 101.2, sore arm, red rash at injection site, for 24 hours following second Pfizer ...
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Fatigue, fever of 101.2, sore arm, red rash at injection site, for 24 hours following second Pfizer dose ER8731. Five days after vaccination with ER8731, on 04/21/2021, was rushed to hospital at 3 pm with acute idiopathic pancreatitis attack.
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| 57 | 2021-04-26 | inability to speak |
Approximately 1-2 minutes after injection, my throat began to close and I was having difficulty brea...
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Approximately 1-2 minutes after injection, my throat began to close and I was having difficulty breathing and speaking. Dizziness followed. I told the attendant that I needed help. They knew that I had my epipen with me. From that time on, all I recall was asking someone to use the pen. An employee successfully administered the epipen. I was then placed on the floor with my head raised as I could no longer swallow or breathe. All that I can recall from that point was speaking with paramedics at the CVS and was feeling successful results from the epi pen. I was taken to Rockledge Medical ER where they took me in immediately and administered steroids and other antihistamines.
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| 57 | 2021-04-26 | bell's palsy |
Right side of face freezes (possible Bell's palsy) upon awakening from sleep; This is a spontaneous ...
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Right side of face freezes (possible Bell's palsy) upon awakening from sleep; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ER20150), via an unspecified route of administration in right arm, on 12Apr2021 at 07:00 PM (19:00), at a single dose, for COVID-19 immunization. The patient had no medical history and concomitant medications. No other vaccine was administered in four weeks. On 13Apr2021 at 06:30 AM, the patient's right side of face freezes (possible Bell's palsy) upon awakening from sleep. No treatment was administered for the event. The patient has not been tested for COVID-19 post-vaccination. The outcome of the event was unknown.
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| 57 | 2021-04-26 | burning sensation | burning redness on vaccination site but tolerate. |
| 57 | 2021-04-27 | pain in extremity |
Left leg pain and swelling a couple weeks after shot one of Pfizer vaccine. After a few more days of...
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Left leg pain and swelling a couple weeks after shot one of Pfizer vaccine. After a few more days of leg not getting any better, saw Doctor who ordered Ultra sound of left leg and CT scan of lungs. Extensive DVT clot found in left leg, low density bi lateral pulmonary embolism in both lower lobes of lungs found from CT scan. Hospital stay for 2 days, Heparin given in hospital and now I'm on eliquis blood thinner. Had gotten my second Pfizer shot 3 days before admittance to hospital.
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| 57 | 2021-04-28 | feeling hot |
Patient stated he was sensitive to the smell of alcohol and needed to turn away after the administra...
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Patient stated he was sensitive to the smell of alcohol and needed to turn away after the administration of the vaccine. He stated like he was feeling like he might pass out. He removed mask, stated he was getting warm, hat removed. He asked to be lowered to the floor. Never lost consciousness. Color pale. Skin diaphoretic. BP 137/84 pulse 80, SpO2 96%. Cold washcloth applied. Rapid response team called. Vital signs monitored. Patient assisted to chair for observation. 10:02 am patient recovered and left the facility in stable condition.
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| 57 | 2021-05-03 | pain in extremity |
Acute Idiopathic Pancreatitis; Acute Idiopathic Pancreatitis; fatigue; fever 101.2; sore arm; red ra...
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Acute Idiopathic Pancreatitis; Acute Idiopathic Pancreatitis; fatigue; fever 101.2; sore arm; red rash at injection site; This is a spontaneous report from a contactable consumer (patient). A 57-years-old male patient received the second dose of bnt162b2 (Pfizer- BioNTech COVID 19, Lot Number: ER8731), via an unspecified route of administration, administered in right arm on 16Apr2021 13:30 (at the age of 57-years-old) as single dose for Covid-19 immunization. Medical history included Acute Idiopathic Pancreatitis. Concomitant medications included Centrum Silver multivitamin and ademetionine (SAM-E). The patient previously received the first dose of bnt162b2 (Pfizer- BioNTech COVID 19, Lot Number: ER2613), via an unspecified route of administration, administered in right arm on 26Mar2021 13:15 (at the age of 57-years-old) as single dose for Covid-19 immunization. Within 24 hours of receiving the second dose of bnt162b2 on 17Apr2021, the patient experienced fatigue, fever 101.2, sore arm, red rash at injection site. Five days after receiving the second dose of bnt162b2, on 21Apr2020, the patient was rushed to the hospital at 15:00 with Acute Idiopathic Pancreatitis. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). The patient was hospitalized for 3days from 21Apr2021 to 24Apr2021. The patient underwent lab tests and procedures which included Nasal Swab/COVID 19 ALLINA MOLECULAR PCR on 21Apr2021 with negative result, CT scan on unspecified date with unknown result, and blood tests on unspecified date with unknown result. Therapeutic measures were taken as a result of the events which included fluids and pain medication. The outcome of the events were recovering.
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| 57 | 2021-05-03 | seizure |
Pfizer COVID-19 Vaccine EUA Patient received dose #1 of Pfizer COVID-19 vaccine on 3/6/2021 and Dose...
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Pfizer COVID-19 Vaccine EUA Patient received dose #1 of Pfizer COVID-19 vaccine on 3/6/2021 and Dose #2 on 4/24/2021. Patient was found down on 4/25/2021 for an unknown amount of time and EMS was called. Patient noted to be seizing on EMS arrival. Blood glucose was noted to be 32 and an amp of D50 was administered. Patient arrested, received CPR (approximately 1 round) and was intubated in the field. His second glucose reading was undetectable and he received a second amp of D50. Patient also received sodium bicarb, calcium, and epinephrine and transported to ED. Patient subsequently transferred to Medical Center. He was treated for septic shock. His mentation remained very poor after pressors weaned off and sedation stopped. He likely had severe brain injury from hypoglycemia and anoxia - poor brainstem reflexed but did have spontaneous breathing - very poor prognosis - patient was extubated for comfort measures and all interventions stopped after family discussion and per their plan.
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| 57 | 2021-05-04 | numbness |
During the two weeks after the first injection the Left shoulder continued with pain and increased i...
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During the two weeks after the first injection the Left shoulder continued with pain and increased in pain. during these same two weeks he noticed gradual and increasing arm weakness and numbness in the outer arm and forearm to the hand. The weakness is so severe that he could not bend the elbow to lift (flexion)the hand up, nor lift the shoulder forward or out.(no flexion or abduction). no new symptoms in the Right arm or either leg. there is severe atrophy of the proximal musculature of the left shoulder and upper arm.
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| 57 | 2021-05-06 | bell's palsy |
Bell's Palsy; This is a spontaneous report from a contactable Other healthcare professional (HCP). A...
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Bell's Palsy; This is a spontaneous report from a contactable Other healthcare professional (HCP). A 57-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 intramuscular on 03Apr2021 (Lot number was not reported) as SINGLE DOSE (at age of 57 years old) for covid-19 immunisation. Medical history included diabetes from an unknown date and unknown if ongoing , covid from an unknown date and unknown if ongoing. Patient did no have any known allergies. Concomitant medication(s) included aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) taken for an unspecified indication, start and stop date were not reported; atorvastatin taken for an unspecified indication, start and stop date were not reported; lisinopril taken for an unspecified indication, start and stop date were not reported; glipizide taken for an unspecified indication, start and stop date were not reported; metformin taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The vaccination was given in a hospital. The patient experienced bell's palsy on 11Apr2021. The event resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of bell's palsy which included Prednisone, Valacyclovir. Outcome of the event was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19. Information about lot/batch number has been requested.; Sender's Comments: Based on vaccine-event chronological association, a causal relationship between event Bell's Palsy and BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 57 | 2021-05-06 | slurring | Pale, some slurred speech. Vitals wnl. |
| 57 | 2021-05-07 | facial paralysis, muscle twitching, numbness, slurring |
stroke like symptoms; on his left side he had face droop; he had a speech slur; he couldn't move his...
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stroke like symptoms; on his left side he had face droop; he had a speech slur; he couldn't move his left arm/couldn't lift his left arm; low blood pressure; his face was numb; his lip was twitching; bad headache; brain fog; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in the left arm on 21Apr2021 14:00 (Batch/Lot Number: EW0169) as single dose (at the age of 57-years-old) for COVID-19 immunisation. Medical history included stroke from 02Feb2020 to 02May2020 (not ongoing). The patient had 3 stroked last year and he was put on ELIQUIS and baby aspirin and a regimen for his strokes. The last one he had was 02May2020 and he has had no problems since then. Last year when he had strokes it wasn't because of his heart it was because of an artery in his brain that went 90 degrees. In Jun2020 they found out that the problem was an artery and that's when the doctor to do the double dose baby aspirin and then everything was fine and he had no episodes at all. Concomitant medications included acetylsalicylic acid (BABY ASPIRIN), lot number: P116218, expiration date: Jan2022 taken for stroke from 02Feb2020 to an unspecified stop date; and apixaban (ELIQUIS), lot number: 1796050, expiration date: Sep2023 taken for stroke from 02Feb2020 to an unspecified stop date. The patient had no additional vaccines on the same date as Pfizer vaccine and had no prior vaccine within 4 weeks. The patient had his first shot of the Pfizer COVID vaccine on 21Apr2021 at 14:00 and stated that they made him go wait for 15 minutes in his car. 10 minutes into waiting after the COVID vaccine, he had to call over the EMT because he had stroke like symptoms. On his left side he had face droop, he had a speech slur and he couldn't move his left arm. The patient was transferred to the hospital and was hospitalized. His CT scan was fine, the CT scan with dye was fine, his MRI was fine, and his heart was fine. The patient wanted to know if he should get the second COVID vaccine because of the reaction that he had from the first COVID vaccine. The patient got the COVID vaccine on 21Apr2021 and on 23Apr2021 he was still having a bad headache, brain fog and there was a deficit on his left side. He can't grab and hold something in his left hand and he has a slight deficit on the left side corner of his mouth. The patient was planning on seeing the provider in the first week of May2021. The patient added that he was told to wait 15 minutes and then 10 minutes in he could feel his face was numb and his lip was twitching and he couldn't lift his left arm. He laid on the horn and the EMS came over and they said that he had stroke like symptoms so they transferred him out of his car and into an ambulance where he had vitals taken and he had another episode of stroke like symptoms. They took him into a different ambulance and had another episode in that ambulance when they were on the way to the hospital. He didn't have anything after that except a bad headache and a slight deficit on his left side, according to them, and just a brain fog like when he was trying to figure out how to put things together and he was still having those at the time of the report. The patient was discharged from the hospital on 22Apr2021. The patient stated that his last stroke was on 02May2020 and he has had no headaches since until he had the COVID vaccine on 21Apr2021. According to the doctors and the neurologist at the hospital he could've had a stroke, he could've had low blood pressure from the vaccine or he could've had a multitude of other things but they recommended him to call Pfizer and CDC for the report. While in the hospital, he had a CT scan without contrast, a CT with contrast on 21Apr2021; an MRI without contrast on 21Apr2021; an echocardiogram without dye and with dye on 22Apr2021 and they did another MRI but of his neck on 22Apr2021; all were normal. The patient was hospitalized for stroke like symptoms, on his left side he had face droop, he had a speech slur and he couldn't move his left arm from 21Apr2021. The event stroke like symptoms resolved with sequel on 22Apr2021. The patient recovered from on his left side he had face droop, he had a speech slur, and he couldn't move his left arm on 22Apr2021. The patient has not recovered from bad headache, brain fog. The outcome of his face was numb was unknown, his lip was twitching and low blood pressure was unknown.
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| 57 | 2021-05-12 | slurring, weakness |
slurred speech; Right arm and right leg weakness; TIA; Fever; Weakness; This is a spontaneous report...
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slurred speech; Right arm and right leg weakness; TIA; Fever; Weakness; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ER8737), via an unspecified route of administration in right arm on 16Apr2021 16:00 as 2nd dose, single for COVID-19 immunization. Medical history included hypertension (Htn) and non-insulin dependent diabetes mellitus (Niddm). Concomitant medications included amlodipine and vitamins nos (MULTIVITAMINS). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ER8730) in the left arm on 26Mar2021. The patient experienced slurred speech, right arm and right leg weakness, transient ischaemic attack (TIA), fever, and weakness, all on 18Apr2021 08:00. The events resulted to ER visit (Emergency room/department or urgent care) and patient was hospitalized for 2 days. Therapeutic measures were taken as a result of the events and reportedly included treatment with blood thinners. Prior to vaccination, the patient was not diagnosed with COVID-19. Since vaccination, the patient has not been tested for COVID-19. The outcome of the events were recovered with sequel. Events seriousness was hospitalization and disability. Information on lot/batch number was available. Additional information has been requested.
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| 57 | 2021-05-13 | seizure | Person suffer a stroke and started having seizures and continuously having Seizures |
| 57 | 2021-05-14 | weakness |
Patient contacted the pharmacy stating that he received the vaccine from us and he informed us of a ...
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Patient contacted the pharmacy stating that he received the vaccine from us and he informed us of a cough but with no fever or other symptoms. The same day the patient had headache, diarrhea, and fever, and eye pain. The cough also worsen and did not go away. He was then treated in the hospital with IV fluids and medication. He spent many days without food and was very weak.
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| 57 | 2021-05-18 | tingling, numbness |
after shot, his mind suddenly went blank, followed with the inability to move his legs at all; Legs ...
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after shot, his mind suddenly went blank, followed with the inability to move his legs at all; Legs became weak. Within 15 minutes of the shot. Went home and rested with weakness in left leg; after shot, his mind suddenly went blank, followed with the inability to move his legs at all; slight numbness; tingling; pain; legs have been heavy; central vestibular disorder; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 16Apr2021 10:15 (Lot Number: ER8731) as 2nd dose, single for covid-19 immunisation. Medical history included Epilepsy, Migraine, Central Vestibular Disorder, and Known allergies: Sulpha Drugs and Shellfish. Historical Vaccine included first dose of bnt162b2 (lot number:ER8727, Administration date= 26Mar2021, Administration time= 12:15 AM, Dose number= 1, Vaccine location= Left arm) for COVID-19 immunisation; Adacel (DTAP) PMC (Sanofi) (vaccine date=11Mar2021, lot number=C5667AA, dose number=1, vaccine location=Left Arm) for immunisation. After bnt162b2 first dose, the pateint had Legs became weak; Could move them, but not stand up on them; Lasted approximately 2-3 hours; Reaction occurred within 15 minutes after the shot; Nurses made her go to the emergency room (ER). Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included clonazepam taken for an unspecified indication, start and stop date were not reported; lacosamide taken for an unspecified indication, start and stop date were not reported; lamotrigine taken for an unspecified indication, start and stop date were not reported; omeprazole taken for an unspecified indication, start and stop date were not reported. After bnt162b2 second dose, the patient experienced Legs became week. Within 15 minutes of the shot. Went home and rested with weakness in left leg. Day after shot, his mind suddenly went blank, followed with the inability to move his legs at all. He could feel them. There was slight numbness, tingling, and pain, but he was not able to move them. He was transported to the ER via ambulance. This reaction lasted about 4 hours. Since then his legs have been heavy and the progress he had made with his central vestibular disorder has thrown him back to almost square one and his physical therapy is now not helping as it did. The adverse events (AE) resulted in Emergency room/department or urgent care. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was recovered with sequelae. Information on Lot/Batch number was available. Additional information is expected.
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| 57 | 2021-05-19 | flushing |
difficulty breathing; face was flushed; heart rate went up; Wheezing; This is a spontaneous report f...
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difficulty breathing; face was flushed; heart rate went up; Wheezing; This is a spontaneous report from a contactable consumer. A 57-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left, at the age of 57 years, on 26Apr2021 (Batch/Lot Number: EW0170) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included autoimmune thyroiditis, allergies, hay fever, allergies to grasses, cheese and weeds; all from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine sodium (LEVOTHYROXIN) taken for autoimmune thyroiditis, start and stop date were not reported and an unspecified Antihistamine. The patient stated that 45 minutes later (26Apr2021) he stated that his face was flushed, his heart was beating fast, he was wheezing and had difficulty breathing but, not severe. He states that these conditions were not serious enough to seek medical attention and reports that they were gone by the end of the next day. The patient reported 5 hours after shot at his symptoms were at about 50 percent of what they were, By the next morning, they were down to about 10 percent and by the end of the day, on 27Apr2021, they were gone. The patient would like to know if this will keep him from getting his second dose of the vaccine. The patient underwent lab tests and procedures which included heart rate: increase on 26Apr2021. The outcome of the events was recovered on 27Apr2021.
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| 57 | 2021-05-24 | night sweats |
Patient received a 2nd dose of Pfizer vaccine on 5/3/2021. Patient presents to the ED on 5/23/2021 w...
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Patient received a 2nd dose of Pfizer vaccine on 5/3/2021. Patient presents to the ED on 5/23/2021 with chief complaint of fatigue, chest pain, shortness of breath on exertion. Patient reports fatigue of 2 week duration associated with right-sided chest discomfort, dyspnea, and night sweats. He reports approximately 1 week ago onset of pleuritic R-sided, nonradiating chest pain, with provocative factor of cough and palliative factor of lying supine. He additionally reports dyspnea on exertion and at rest and night sweats of 1 wk duration. CT chest angio showed Large Pericardial effusion, moderate Left pleural effusion, mild right pleural effusion, ascites. On 5/24/2021, patient underwent pericardiocentesis with 800cc of reddish fluid drainage, and left thoracocentesis with transudative fluid. Cytology is pending.
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| 57 | 2021-05-27 | seizure, feeling of body temperature change |
body aches; chills; headache; dizziness; goes from being cold and hot; passing out a few times; shak...
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body aches; chills; headache; dizziness; goes from being cold and hot; passing out a few times; shaking similar to seizure/eyes kind of glazed; This is a spontaneous report from a contactable consumer (patient's wife) reported that a 57-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19, lot number: EW0182), via an unspecified route of administration, administered in arm left on 11May2021 08:00 (at the age of 57-years-old) as 2nd dose, single dose for covid-19 immunisation. The vaccine was administered at the Pharmacy/drugstore. The patient medical history included covid before, he had a bad case of it from Nov2020. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19, lot number was not reported) on 20Apr2021 (at the age of 57-years-old) as 1st dose, single dose for covid-19 immunisation, and experienced all of the same symptoms (body aches, chills, goes from being cold and hot, headache and dizziness) but he did not pass out. The patient always gets the flu vaccine. The patient's concomitant medications were not reported. On 11May2021 15:15, the patient experienced passing out a few times, eyes kind of glazed, and shaking similar to seizure; and at 19:00, the patient body pain, chills, headache, dizziness and goes from being cold and hot. The outcome of the events was unknown.
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| 57 | 2021-05-28 | feeling of body temperature change |
body aches; chills; headache; dizziness; goes from being cold and hot; This is a spontaneous report ...
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body aches; chills; headache; dizziness; goes from being cold and hot; This is a spontaneous report from a contactable consumer. A 57-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 20Apr2021 08:00 (Batch/Lot Number: EW0171) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 20Apr2021, body aches, chills, goes from being cold and hot, headache and dizziness. Reporter clarifies that after the first dose of the covid vaccine, patient had all of the same symptoms but he did not pass out. Patient never felt 100 percent after receiving the first dose of the covid vaccine. All of the same symptoms after the first dose began the night patient received the first dose of the covid vaccine, 20 Apr 2021. The outcome of the event goes from being cold and hot was unknown while not recovered for the other events.
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| 57 | 2021-05-30 | hypersensitivity of all senses |
Skin hurting/sensitivity (Day 1 forward), severe chills (day 2 forward), headache (day 1 forward), f...
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Skin hurting/sensitivity (Day 1 forward), severe chills (day 2 forward), headache (day 1 forward), fatigue (day 1 forward), mild cough on/off, eye pain (? day 4 forward), achey (day 1 forward), chest rash (? day 3 forward), fever (? day 5 forward 101.9 day 5), back pain (? day 5 forward), labored breathing (? day 5 forward), diarrhea (? day 5 forward), sore throat (? day 5 forward) vomit (day 7). Symptoms of chills and miserable feeling increased day 4 on. Tylenol, Albuterol on day 6, Day 8 hospitalized, antibiotics and oxygen, Sepsis and shock, less than one day in hospital - passed on 3/2/21 am.
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| 57 | 2021-05-31 | burning sensation |
At 4:00 p.m. after shot, had nausea, fever, chills and headache. This lasted until 8:00 p.m (4hrs). ...
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At 4:00 p.m. after shot, had nausea, fever, chills and headache. This lasted until 8:00 p.m (4hrs). Symptoms went away but started again at 1:15 a.m and lasted until 4:15 a.m. After waking up at 8:00 a.m. noticed pronounced ringing in my right ear. Later that day noticed that the top of my toes (at the base of my toes) had a burning sensation, my lower back hurt and a general overall unwell feeling. The ringing in my right ear has been nonstop since it started. The other symptoms have come and gone intermittently but are still present.
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| 57 | 2021-05-31 | pain in extremity, numbness | Deltoid numbness. persists. Increasing pain in deltoid |
| 57 | 2021-06-04 | pain in extremity, flushing |
Pain at injection site; Pain in side of neck; severe headache; feeling flushed; aching in back; achi...
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Pain at injection site; Pain in side of neck; severe headache; feeling flushed; aching in back; aching in legs; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old adult male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL3247), via an unspecified route of administration in the left arm on 16Mar2021 at 11:45 AM, as a single dose for COVID-19 immunisation. Medical history was not reported. The patient reported that he did not have any allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications reported as none. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: El3247), via an unspecified route of administration in the left arm on 23Feb2021 at 13:30 PM, as a single dose for COVID-19 immunisation. On 17Mar2021 at 02:00 AM, the patient experienced significant pain at injection site spreading up the side of his neck, severe headache, feeling flushed, aching in back and legs. No therapeutic measures were taken for the adverse events. The clinical outcome of pain at injection site, pain inside of neck, severe headache, feeling flushed, aching in back and legs were recovering at the time of this report. No follow up attempts are needed. No further information is expected. Amendment: This follow-up report is being submitted to amend previously reported information: patient's first name added in patient tab, patient's Country added and phone/email added in patient tab, Patient's age/unit added in patient tab, Patient's Race information and Ethnic group added in patient tab, duplicate Reported Indication of BNT162B2 removed, For Past Drug Event with BNT162B2 1st dose: Condition Type updated from Past Drug Event to Historical Vaccine; Age/Units captured as 57 years per vaccination date was 23FEB2021, duplicate Reported Indication of BNT162B2 removed, treatment received ticked as No. Follow-up (02Jun2021) Amendment: This follow-up report is being submitted to amend previously reported information patient information and treatment information added.
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| 57 | 2021-06-06 | tingling, numbness |
For 2-3 weeks, episodes of L ear numbness, top of ear, lasting for 10-15 seconds multiple times duri...
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For 2-3 weeks, episodes of L ear numbness, top of ear, lasting for 10-15 seconds multiple times during the day and then goes away. But comes back, sometimes some electric feeling.
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| 57 | 2021-06-07 | pain in extremity |
Reports pain in left arm since second shot, pain progressed 2-3 days after injection. Unable to use...
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Reports pain in left arm since second shot, pain progressed 2-3 days after injection. Unable to use his arm at his doctor visit on 5/4/21. Diagnosed with shoulder injury related to vaccine administration. F/U appointment on 6/7/21 reports able to use his left arm, still has pain off/on . Has been going to PT for three weeks and has shown increased range of motion. Improved but still not back to normal, still unable to sleep on left side. Continuing PT.
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| 57 | 2021-06-09 | inability to speak |
Approximately 1-2 minutes after injection, my throat began to close and I was having difficulty brea...
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Approximately 1-2 minutes after injection, my throat began to close and I was having difficulty breathing and speaking. Dizziness followed. I told the attendant, store manager, that I needed help. They knew that I had my epi pen with me. From that time on, all I recall was asking someone to use the pen. An employee sucessfully adminstered the epi pen. I was then placed on the floor with my head raised as I could no longer swallow or breathe. All that I can recall from that point was speaking with paramedics at the CVS and was feeling successful results from the epi pen. I was taken to ER where they took me in immediaately and administered steroids and other antihystemines. After some
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| 57 | 2021-06-09 | pain in extremity |
dizziness 15 min after vaccine, called patient, only sore arm now, will follow up with PCP if any ot...
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dizziness 15 min after vaccine, called patient, only sore arm now, will follow up with PCP if any other symptoms
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| 58 | 2020-12-31 | weakness |
Tested positive Covid-19 infection, Cough, bronchospasm, weakness, muscle pain, chest congestion, n...
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Tested positive Covid-19 infection, Cough, bronchospasm, weakness, muscle pain, chest congestion, nasal congestion, Loss of appetite since vaccine given,
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| 58 | 2021-01-01 | pain in extremity |
Injection site pain and tiredeness day after injection. Severe left sided low back pain centered in ...
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Injection site pain and tiredeness day after injection. Severe left sided low back pain centered in sacroiliac joint, next day radiating into left leg and left thorax on Sunday, five days after injection. Severe disruption in all ADLs necessitating narcotic pain medication and an emergent visit with chiropracter. This pain is somewhat better but still persists today 14 days after onset!! This is absolutely miserable. I think I'd rather have COVID
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| 58 | 2021-01-04 | pain in extremity |
sinus issues; positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; right arm ...
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sinus issues; positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; right arm sore; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer (patient) reported that a 58-year-old male patient received the first dose of BNT162B2 (lot number: EH9899; Expire Date: 31Mar2021), via an unspecified route of administration, in arm, right upper, on 16Dec2020 11:10 AM at single dose for COVID-19 immunization. The vaccination facility type was hospital. The vaccine was not administered at military facility. Patient's medical history (including any illness at time of vaccination) was none. The patient got ill from all pain medications- from prescription strength pain killers to OTC products such as tylenol, ibuprofen and aspirin. All of them make him sick- experienced hot flashes and nausea. No additional vaccines administered on same date of the Pfizer suspect vaccine. Prior vaccinations (within 4 weeks) was none. The concomitant medication included 2 different blood pressure pills, mentioning Lisinopril, but stated he did not think his blood pressure pills were relevant to what he was experiencing with the COVID-19 Vaccine. A MRI tech (clarified by caller as MRI technologist) at a hospital who received the COVID-19 Vaccine on 16Dec2020 (caller clarified he received the vaccine at 11:10 AM on 16Dec2020). Caller stated on 17Dec2020 he had signs of aches and pains allover, a sore arm (clarified as his right arm), no fever. He also experienced sinus issues and a loss of sense of smell. Clarified his right arm was sore for only a day, his sinus issues started on 20Dec2020, and his loss of the sense of smell gradually started on 22Dec2020. He stated on 23Dec2020 he had a COVID-19 test performed and the test result was positive for the COVID-19 virus. Caller asked since he had the first COVID-19 Vaccine dose, and has now tested positive for the COVID-19 virus, should he get the second COVID-19 Vaccine dose scheduled for 06Jan2021. Patient's Height: 5' 8'' as provided by caller, who stated he has shrunk 1''. No further details provided. Patient's Weight: 169 lbs. as provided by caller, who stated his weight was as of today. Reported he worked an overnight shift, clarifying he was injected with the COVID-19 Vaccine after his overnight shift was finished on the morning of 16Dec2020. He stated he came back to work later in the day on 16Dec2020 to work another overnight shift from 9:00 PM to 7:30AM. He said after he finished is overnight shift on the morning of 17Dec2020, he went home to bed, and woke up around 12:00 PM on 17Dec2020. He said when he woke up, he started to feel aches and pains allover, and after that noticed he was getting chills periodically. Clarified he experienced the aches and pains allover for a couple of days, and then the aches and pains went away. He said he then started to get the feeling a sinus infection was coming on, but he never got a sinus infection. He said the aches, pains, and chills came back. Reported his co-worker received the COVID-19 Vaccine on Saturday, 19Dec2020, clarifying his co-worker did well with the COVID-19 Vaccine. He clarified his employer was concerned that he may have exposed his co-worker to COVID-19 when the two worked together on the overnight shift of 22Dec2020. He said both he and his coworker kept their PPE on the whole time they worked except when the two ate dinner. He said the two of them sat at a round table about 6 feet apart, and took off their masks to eat. He said his partner agreed that the two of them were right at 6 feet apart when the sat at the table to eat dinner, so their employer deemed his coworker as low risk. Reported on 22Dec2020 he had to go back to work, so he was asked for his temperature at the time, which was 98.8 degrees. He did have a flu shot previously. He was instructed as long as he doesn't have a fever over 100 degrees, he can work. The caller said he went to work on 22Dec2020, and read an email from his employer's wellness office. He said the wellness office email spoke about the COVID-19 Vaccine side effects, and instructed employees to contact the wellness office with any COVID-19 Vaccine side effects experienced. He said he left a voicemail with his employer's wellness office explaining exactly what his COVID-19 Vaccine side effects were. He said he instructed his employer's wellness office call him in the afternoon because he was going to go home, go to bed, and wake up at noon on 23Dec2020. He stated he spoke with his employer's wellness office at around 11:30 AM on 23Dec2020, and the wellness office asked for him to go to the hospital, and have a COVID19 test. Caller stated his employer performed a COVID-19 nasal swab test, and on 24Dec2020, he was told he was COVID-19 positive. He said his employer backed up his quarantine start date to 17Dec2020 (the first day he experienced symptoms), and had him follow a 10-day quarantine until 27Dec2020. He stated today, 28Dec2020, was the first day he has been off quarantine. Reported he was not saying he got COVID-19 from receiving the COVID-19 Vaccine, but should he have the second COVID-19 Vaccine injection. Clarified his symptoms were intermittent, and started coming back around 20Dec2020. Reported he was not experiencing any scratchiness in his throat, and his eyes were not watering. He said he has had no cough, no sneezing, and no trouble breathing. He said in general, it felt like something was coming on, saying it was building up, but not getting out. Clarified he had gone back to work on 23Dec2020 to have his COVID-19 nasal swab test performed, and was told by his employer on 24Dec2020 that the COVID-19 nasal swab test was positive. No AE required a visit to emergency room or physician office. The outcome of the event right arm sore was recovered on 18Dec2020 and the other events was unknown.
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| 58 | 2021-01-05 | tingling |
Patient reported a fever and tingling to his face in the morning on 12/17/20. EHS followed up with h...
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Patient reported a fever and tingling to his face in the morning on 12/17/20. EHS followed up with him at 11:30 am on 12/17. He reported that the fever had resolved, and he was no longer having tingling to his face. He denied paralysis to his face, shortness of breath, and chest pain.
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| 58 | 2021-01-06 | numbness |
LEFT FACIAL AND TONGUE NUMBNESS - WORK UP CVA NEG Narrative: Developed left facial and tongue numbn...
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LEFT FACIAL AND TONGUE NUMBNESS - WORK UP CVA NEG Narrative: Developed left facial and tongue numbness 4 hours after vaccine - went to ER and admitted for 2 days, negative workup for CVA or other acute etiology. Symptoms resolved prior to discharge from hospital
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| 58 | 2021-01-06 | pain in extremity |
01/06/2021 2nd dose: Sore arm, metallic taste in mouth mild nausea tired feeling 12/17/2020 1st dos...
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01/06/2021 2nd dose: Sore arm, metallic taste in mouth mild nausea tired feeling 12/17/2020 1st dose Pfizer vaccine :Sore arm, metallic taste in mouth mild nausea tired feeling and headache .
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| 58 | 2021-01-06 | tingling | Facial redness and tingling sensation |
| 58 | 2021-01-07 | pain in extremity |
Heart rate increased; Swelling arm; Arm soreness; soreness at the vaccine injection site; This is a ...
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Heart rate increased; Swelling arm; Arm soreness; soreness at the vaccine injection site; This is a spontaneous report from a contactable consumer. A 58-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EJ1686, expiration date unknown) via an unspecified route of administration on 28Dec2020 at 13:00 (at the age of 58-years-old) at an unspecified dose in the upper left arm for COVID-19 vaccination. Medical history was reported as "no pre-existing conditions." He mentioned that he reviewed his allergies with a pharmacist prior to vaccination but did not specify what his allergies were. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was a tobacco user from an unknown date. The patient also reported a history of pneumonia which was reported to have occurred on seven different occasions following each of seven different vaccinations with the flu vaccine (manufacturers unknown) prior to 2013. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. He stated that after receiving the COVID 19 Vaccine he had side effects. He said the side effects went away at twenty four hours later, but he is still having one side effect, and has a concern. He clarified that he has an elevated heart rate since getting the COVID 19 Vaccine. He said he has never had an elevated heart rate before getting the COVID 19 Vaccine. He reported his heart rate is normally low, between 62-65. He said when he was at work on 28Dec2020 his heart rate was OK, but prior to going to bed that night his heart rate was 93 - 95. He said he thought at first he was just stressed. He also reported the COVID 19 Vaccine is the only thing he has taken. He mentioned that his heart rate has been down to 93, but then up to 105, and higher. He specified that he first presented with an elevated heart rate between 4:00 5:00PM on Tuesday, 29Dec2020. He said the elevated heart rate subsided enough for him to sleep later that day. He said he then started work around 10:00AM today, 30Dec2020, and felt the elevated heart rate in himself, and didn't say anything to anyone at work. He said when his heart rate got bad, it was about 12:30PM today and that today (30Dec2020) at work he didn't feel right at lunch, so he took his oxygen level and heart rate. He said his heart rate was 141. He said he called his primary care doctor, but didn't go to the emergency room. He said he doesn't have chest pain. He said he said something about his heart rate to a staff member at work, and the staff member tested his heart rate, and told him it was 141. He said he spoke to the nurse at his doctor's office, and the nurse said the doctor couldn't do much, and that he could go to emergency room or their practice's urgent care that is open until 7:00PM. He said he tried to go to the hospital emergency room, but ended up driving by because the hospital was so busy they were triaging patient's in the parking lot. The patient also experienced arm swelling and arm soreness following the vaccination on 28Dec2020. He said he could feel the soreness at the vaccine injection site when he moved his left arm. He stated that the swelling was down to his biceps and it resolved within 12- to 14 hours after the vaccination. As treatment, the patient took a generic 81 mg Baby Aspirin (UPC Number: 050428323922, Lot Number: P110657 Expiration Date: May2020) on 30Dec2020 between 3:00 and 3:30. The patient stated that the generic 81mg baby aspirin was an expired product. The clinical outcome of heart rate increased was not recovered and the clinical outcome of arm swelling, arm soreness and vaccination site soreness was recovered on 28Dec2020.
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| 58 | 2021-01-10 | flushing, hypersensitivity of all senses |
Taste of the vaccine in my mouth as soon as administered followed by full body flushing and sweating...
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Taste of the vaccine in my mouth as soon as administered followed by full body flushing and sweating and hypersensitivity to sound and touch sense of depersonalization, anxiety Next morning, severe muscle and joint pain
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| 58 | 2021-01-10 | flushing, tremor, feeling hot |
Patient complained of non visible arm shaking. Shortly thereafter complained of feeling warm and was...
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Patient complained of non visible arm shaking. Shortly thereafter complained of feeling warm and was becoming flushed. Nurse checked NP with reading of 212/104. Patient complained of headache and was taken to emergency department where BP was 240/112.
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| 58 | 2021-01-11 | sensory loss, speech disorder |
right arm weakness; loss of sensation intermittently; lightheaded, dizzy; briefly difficult to speak...
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right arm weakness; loss of sensation intermittently; lightheaded, dizzy; briefly difficult to speak on one occasion; This is a spontaneous report from a contactable physician. A 58-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ELO142, expiry date: unknown), intramuscular on the right arm on 04Jan2021 15:00 at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. The patient experienced right arm weakness/loss of sensation intermittently lasting <5 minutes on at least 5 occasions on 05Jan2021. Patient also experienced lightheaded, dizzy, and briefly difficult to speak on one occasion on 05Jan2021. The events resulted in an emergency room visit but no treatment was given. Outcome of the events was recovering. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. There were no other vaccine administered within 4 weeks prior to the COVID vaccine.
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| 58 | 2021-01-12 | weakness, pain in extremity | Severe arm pain Fatigue No energy |
| 58 | 2021-01-12 | slurring, bell's palsy |
Less than 2 days after having the 1st shot of the COVID-19 vaccine, I woke up at 2am and experienced...
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Less than 2 days after having the 1st shot of the COVID-19 vaccine, I woke up at 2am and experienced Bell's palsy on the left side of my face...and had minor heart pain...was dizzy...had loss of balance...slurred speech, I had all of the symptoms of a stroke. Later in that same morning the swelling starting going down, so I waited to go to the emergency room...did not want to spend the money for all of the tests. I woke up the next morning and still had heart pain, so I decided to go to emergency room .
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| 58 | 2021-01-12 | pain in extremity |
fatigue; threw up a little; patient received the second dose of BNT162B2 on 06Jan2021; soreness in h...
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fatigue; threw up a little; patient received the second dose of BNT162B2 on 06Jan2021; soreness in his right arm/soreness in his legs/legs were hurting; did not sleep good; sick to his stomach; This is a spontaneous report from a contactable consumer (patient himself). A 58-year-old male patient the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL0140), via intramuscular on 06Jan2021 15:00 in right arm at 0.3 mL (30mcg), single for preventative. There were no medical history and concomitant medications. Patient had the first dose of BNT162B2 vaccine on 19Dec2020 for covid-19 immunization. No investigation assessment was received. Patient had the second Pfizer COVID19 vaccine shot yesterday around 15:00 on 06Jan2021. He was asking if it was normal to be sore, patient had a little fatigue on 07Jan2021 and be sick to his stomach in Jan2021. The soreness in his right arm started last night (06Jan2021). He experienced soreness in his legs. He did not sleep good and his legs were hurting last night through the night. As of now his legs do not seem as bad. Patient went to work this morning and then he left work to go back home. He ate a cake and milk before he left for work. He threw up a little on 07Jan2021. It did not take much for him to gag, he even gags when brushing his teeth. Right now and within the last hour, he had not felt sick to his stomach. Outcome of soreness in his right arm/soreness in his legs/legs were hurting was not recovered, of fatigue was recovering, of sick to his stomach was recovered on 07Jan2021, of other events was unknown.
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| 58 | 2021-01-13 | one side paralysis |
He collapsed with left sided hemiparesis; Stroke; Rt basal ganglia hemorrhage w/ edema and mass effe...
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He collapsed with left sided hemiparesis; Stroke; Rt basal ganglia hemorrhage w/ edema and mass effect.; Rt basal ganglia hemorrhage w/ edema and mass effect.; Low platelets, 114; His bp as high as 200s/100; Hand weakness; Myalgia; Fever; Severe fatigue; This is a spontaneous report from a contactable physician. A 58-year-old male patient received first dose of bnt162b2 (Pfizer BioNTech COVID vaccine), intramuscularly on 16Dec2020 at a single dose for COVID-19 immunization. Medical history included hypertension with reported med noncompliance in the last few months due to stress. Concomitant medication included hypertension medications in two weeks. The patient was presumed neg covid status prior to vaccine. He worked as a Pulm/critical care physician. He reported fever, myalgia, fatigue on 16Dec2020. Next day (17Dec2020), he took off from work due to his symptoms. The following day (18Dec2020), he came to work. He c/o ongoing severe fatigue & hand weakness in am. Staff noted him to be evaluating his hands during clinic. At 12:15, he collapsed with left sided hemiparesis. The reporter had suspicion for stroke. He was transported to the Emergency Room (ER), head CT showed Rt basal ganglia hemorrhage w/ edema and mass effect. Labs notable for Low platelets, 114 (unknown baseline) on 18Dec2020, normal coags on an unspecified date. BP recorded as 179/101, but it was noted in trauma room his bp as high as 200s/100. He had a history of hypertension with reported med noncompliance in the last few months due to stress. Patient was transferred for further care. Full course was unknown but had rebleed there with low plts. Adverse event (he collapsed with left sided hemiparesis) resulted in hospitalization (22 days), life threatening illness (immediate risk of death from the event), disability/incapacitating or permanent damage. Treatment was received for adverse events. Results of tests and procedures for investigation of the patient: on 18Dec2020, Nasal Swab test: negative. The outcome of events was not recovered. Unknown if any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. Information on the lot/batch number has been requested.; Sender's Comments: Collapsed with left sided hemiparesis/suspicion for stroke are as consequences of basal ganglia hemorrhage with edema, which is caused by worsening of hypertension. Low platelet also contributes to brain hemorrhage. All these serious events are unrelated to the vaccine use. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 58 | 2021-01-13 | tingling |
Tingling sensation, flu like symptoms, chest pain, sore throat, tiredness. ER visit for chest pains...
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Tingling sensation, flu like symptoms, chest pain, sore throat, tiredness. ER visit for chest pains, labs and testing done, heart attack ruled out. Patient reported that symptoms were result of Covid Vaccine side effects. Onset of symptoms began on 1/11/21, ER visit on 1/13/21 for chest pains, returned home on 1/13/21 after tests were completed. Patient reports feeling better.
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| 58 | 2021-01-15 | tremor |
Patient had COVID-19 infection April 2020, ataxia and myoclonus developed, treated with IVIG and ste...
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Patient had COVID-19 infection April 2020, ataxia and myoclonus developed, treated with IVIG and steroids at that time. June 2020 had full recovery after PT. Pt received Pfizer COVID-19 dose 1 on 12/22/20 and developed similar symptoms to above on 1/7/2021. Ataxia and tremor on examination, no myoclonus at this time.
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| 58 | 2021-01-16 | tremor, pain in extremity |
Severe body aches, chills, fever, shaking, lethargy all staring about 12 hours after 2nd dose; sympt...
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Severe body aches, chills, fever, shaking, lethargy all staring about 12 hours after 2nd dose; symptoms lasted about 18 hours. Mild arm soreness occurred with both doses.
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| 58 | 2021-01-19 | pain in extremity |
initial symptoms 1 hour post vaccine: joint pain left arm (shoulder/elbow/wrist), joint pain bilater...
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initial symptoms 1 hour post vaccine: joint pain left arm (shoulder/elbow/wrist), joint pain bilateral ankles and joint pain to right foot specifically 2nd and 3rd MTP, back pain and headache. Left arm pain, back pain and headache resolved within 48 hours. Patient has continued with moderate pain into right foot (2-3rd MTP joints), now with forefoot edema and erythema and continued bilateral ankle pain.
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| 58 | 2021-01-20 | feeling cold | Came down with cold chills and sweats. And feeling run down |
| 58 | 2021-01-20 | tremor |
Hands started to shake; shaking of the hands that I could barely write/My legs were shaking very bad...
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Hands started to shake; shaking of the hands that I could barely write/My legs were shaking very bad while I was walking down three slides of stairs; My hands became weak; Soreness of the arm the injection site for 2 days; This is a spontaneous report from a contactable physician (patient himself). A 58-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1685; expiry date: unknown) via an unspecified route of administration, on 22Dec2020, at a single dose, for COVID 19 immunization. Relevant medical history included COVID infection last Apr2020. On the peak of the COVID pandemic he had the COVID infection, he lost the sense of taste and smell, had diarrhea although he did not have fever and did not have coughing. He also has medical history of opsoclonus myoclonus ataxia syndrome. He was tested for COVID, he was positive 2 times and then they did PET scan, MRI from head to toe. They were looking for tumor, neuroblastoma, what was causing the shaking, the myoclonus, the opsoclonus, the ataxia, they could not find anything. They gave him convalescent plasma and then they gave him immunoglobulin human normal (IVIG) 5 doses and they gave him high dose of steroid to the point that his blood sugar was reaching sky high they have to give him insulin. He was hospitalized 2 times, 3rd time was 2 days and sent home and then it got worst, so he was readmitted for another '3' days. So, he was sent home on clonazepam, it makes him drowsy and he went for physical therapy and slowly after almost after 8 weeks his symptoms disappear, and he was able to go back to work. His symptoms all recovered by the end of May, towards the beginning of Jun2020 he went back for the swab test, it was negative, COVID PCR negative and my antibody was positive. Concomitant medications included clonazepam, metformin and simvastatin. Patient went back to work and have no symptoms until this 07Jan2020. Like almost 3 week or two and half weeks after he received the Pfizer COVID vaccine. Two and half weeks later he started having symptoms like shaking of the hands that I could barely write and yesterday he could barely walk down the stairs. The patient received the Pfizer COVID vaccine on 22Dec2020. Immediately after the vaccination the patient felt that his hands became weak. He ignored it because it went away, like after a minute or so it went away. He went home and nothing happened, except for the soreness of the arm the injection site for 2 days, which really did not bother him. Then this past Thursday, 07Jan2021, he went to the church, he was lightning a candle and his hands started to shake, he can barely light a candle. He was able to do it although his hands were shaking. So, he went home. He ate breakfast, and called his neurologist and he said just to observe and then it went away. On Saturday night (09Jan2021) he noticed that his hands were shaking again when he was typing in the keyboard. He can manage to type but his hands were shaking. He went to sleep and just ignored it. Then yesterday, Sunday he worked again, it became worse, his handwriting was shaking. He was really holding on to the pen to write legibly and then he was in the third floor hospital, elevators did not work. So, he walked down through the stairs, both of his legs were shaking very bad while he was walking down three slides of stairs but he thought he came to the ground so he was able to walk on the flat floor on the street and able to walk home. The patient did not receive treatment for the events. Outcome of the event tremor was unknown, while for the other events was unknown. The consumer considered a causal relationship between the events and the vaccine.
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| 58 | 2021-01-21 | weakness |
Tempeture of 101, Spike in blood pressure, Spike in sugar of 310, Pains in Joints weakness, Dizzines...
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Tempeture of 101, Spike in blood pressure, Spike in sugar of 310, Pains in Joints weakness, Dizziness
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| 58 | 2021-01-21 | numbness |
Has onset of symptoms after receiving the COVID vaccine: abdominal tightness, shooting pains in fac...
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Has onset of symptoms after receiving the COVID vaccine: abdominal tightness, shooting pains in face, numbness to back of head over the next 3 days. He is unsure if it is vaccine related. He is following up with Clinic to determine if this is a reaction to the vaccine or if he has something else going on.
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| 58 | 2021-01-21 | pain in extremity |
upper bicep pain/soreness around upper part of bicep; tendonitis; lymphadenopathy; sore deltoid; Thi...
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upper bicep pain/soreness around upper part of bicep; tendonitis; lymphadenopathy; sore deltoid; This is a spontaneous report from a contactable Other Healthcare Professional (patient). This 58-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot # EI0142, expiry date Mar2021), intramuscular once to the left deltoid, on 28Dec2020 at single dose for COVID-19 immunisation. Age at vaccination was 58-years-old. Medical history was none. Concomitant medications included an antihypertensive medication taking for several years. On 28Dec2020 the patient experienced side effects including sore deltoid (lasted for 2 days, Dec2020), and on 01Jan2021 the patient experienced upper bicep pain which he felt 5 days later (his friend said it may be lymphadenopathy). The caller had the COVID vaccine on 28Dec2020, and from 28Dec2020 he had a sore deltoid for a couple days, but then almost a week later developed, he thought it was tendonitis, it was the upper part of his bicep, really he could not extend his arm all the way, it was so painful in that area, and it's still somewhat painful, but better. The sore deltoid was pretty much after the shot and into the next 48 hours, that went away, then he noticed this soreness around the upper part of his bicep, not until, probably, maybe 5 days later, on 01Jan2021. He was chatting with someone, who mentioned soreness in the underarm area, that person felt it was lymph nodes, so maybe, there is possibility, caller thought this was muscle pain, as it hurts when he tried to extend his arm, it does not hurt when sitting here, but when he extends, especially over his head, it is really quite painful but it's lessened, he thought it was a tendonitis, but it could be the lymph nodes active or enlarged, he is not sure, he has never noticed lymph node pain, so he never knew what it was. Causality for soreness around upper part of bicep was reported as yes. He is pretty sure, since he has not done anything that aggravated that muscle, he can't think of anything, and it is in the general vicinity of the injection. States he is on an antihypertensive medication, but has been taking it for several years. He doesn't want to go through a report for the person he spoke to, who mentioned soreness in the underarm area, but it is interesting: the caller told him that had soreness, caller knows he also did report it, he reported it to Pfizer, actually he doesn't know if it was Pfizer or Moderna, but he reported it to whichever company, and said he thought was inflamed lymph nodes, so that was the first time he thought it was not muscle, but maybe the lymph node's reaction to vaccine, he has never experienced this kind of discomfort, he could not straighten his arm, as he would straighten the pain was at the upper insertion at the bicep, so that is where he came to this conclusion, his preliminary conclusions, he never thought it would persist this long. He thought, as time went by, it would be better tomorrow, and it has gotten better, but has not gone away. Sore deltoid was reported as non-serious while soreness around upper part of bicep was reported as serious medically significant because it has persisted for so long, he would have not expected it to keep going on, but it is almost going on two weeks. Outcome of the event soreness around upper part of bicep, lymphadenopathy, and tendonitis was not recovered while the outcome of the sore deltoid was recovered in Dec2020. His second dose is scheduled tomorrow (14Jan2021) and wants to know if he can still take it.; Sender's Comments: There is a reasonable possibility that the events myalgia and lymphadenopathy were related to BNT162b2 based on known drug safety profile. Based on the close temporal relationship, the association between the event tendonitis with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 58 | 2021-01-22 | muscle spasms | Chest pain and cramping with difficulty breathing. |
| 58 | 2021-01-22 | sciatica |
Left lower extremity sciatica came on gradually beginning Dec 31, 2020. Symptoms worsened requiring...
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Left lower extremity sciatica came on gradually beginning Dec 31, 2020. Symptoms worsened requiring hospitalization on January 11, 2021. MR Lumbar spine demonstrated a stable mild disc bulge left paracentral at L5S1 unchanged from 2013.
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| 58 | 2021-01-24 | weakness | Body aches, fatigue, weakness |
| 58 | 2021-01-28 | feeling cold, tremor |
Pt reported to Covid-19 vaccination clinic for Pfizer lot #EL3302 first dose.Reported allergy to sul...
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Pt reported to Covid-19 vaccination clinic for Pfizer lot #EL3302 first dose.Reported allergy to sulfa drugs and was in observation for 30 minutes. At approximately 25 minutes post vaccination at 10:15am, Pt signaled that he wanted to leave & was instructed to stay 5 more minutes. Pt anxious and began to shake, saying he could not breathe. Vitals were 147/88, HR 86, O2 98% on RA. Pt was reclined on floor and reported being cold and was striking his head on the blanket; head stabilized. Patient was alert and oriented x3, but complained of chest pain. EMS called, arrived at 10:25, Vitals: 144/92, HR83 O2 99% on 2L. Pt stable & transported to hospital by EMS at 10:35am
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| 58 | 2021-01-28 | tenderness, tingling, pain in extremity |
Pfizer vaccine in LH arm, arm was sore for 2 days, arm continues to feel tender and has pins and nee...
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Pfizer vaccine in LH arm, arm was sore for 2 days, arm continues to feel tender and has pins and needles feeling, worse when elevated or moved
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| 58 | 2021-01-29 | pain in extremity |
Severe pain in injection arm, profuse sweating on second day. A lot of vomiting causing me pass out...
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Severe pain in injection arm, profuse sweating on second day. A lot of vomiting causing me pass out out and be taken to the hospital via ambulance.
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| 58 | 2021-01-31 | pain in extremity |
General malaise; Back pain; flu like symptoms; couldn't go back to sleep; generalized muscle pain; C...
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General malaise; Back pain; flu like symptoms; couldn't go back to sleep; generalized muscle pain; Chills; Injection site pain; arm soreness; he did have injection site pain again and arm soreness after the second injection; This is a spontaneous report from a contactable physician (patient). A 58-year-old male patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL1203), via an unspecified route of administration in left arm on 14Jan2021 09:00 at single dose for COVID-19 immunization. Vaccination facility type was hospital. Medical history included hypertension, high cholesterol, heart rate irregular. Ongoing concomitant medications included metoprolol for heart rate control, telmisartan (TELMISARTAN) oral at once daily for Hypertension, rosuvastatin calcium (CRESTOR) oral at 40mg once daily for high cholesterol. The patient received first dose bnt162b2 (Lot Number: EJ1685) at the age of 58-year-old for COVID-19 immunization and experienced injection site pain and arm was pretty sore. Reports he received the first dose of the Pfizer COVID 19 vaccine three week prior to the second dose. First states that was about 14Dec2020, but then clarified from his vaccine card, he received the first dose of the vaccine 23Dec2020 at 09:00AM in the left arm. He noticed injection site pain that lasted about two days and his arm was pretty sore. Both of these effects all completely resolved before the second dose. He received the second dose of the vaccine 14Jan2021 at 09:00 in the left arm. That night on 15Jan2021 at about 03:00AM in the morning he woke up with chills and general muscle pain, which he described as flu like symptoms. Adds he took his temperature but it was normal on 15Jan2021. He couldn't go back to sleep on 15Jan2021 so he took some Motrin. The next morning 15Jan2021 at 07:00 AM when he woke up, he felt okay but then in the late afternoon he started to feel the pain in his back and chills. He took Motrin and his pain and chills were gone after four or five hours. Adds it seemed like it took awhile for the Motrin to have an effect that time. Then the third day 16Jan2021, he had the same back pain and chills. He took Motrin and the pain and chills went away after 2 hours. The fourth day he only felt mild muscle pain in his back and just a little chills. He took Motrin again and it went away pretty quickly. Clarified he took Motrin at 16:00 and his pain had gone away by 16:30. He was fine by 19:00PM that evening. Adds he felt general muscle pain starting the first night he woke up and continuing with the back pain but each day all his symptoms got milder. The generalized muscle pain was minimal yesterday. He was still sore but not as bad. All of his symptoms are gone now; so far today he has not had any symptoms of the effects he reported. Adds he did have injection site pain again and arm soreness (Jan2021) after the second injection but it resolved completely by the next day (15Jan2021) after the second dose and was not as bad. Adds he felt a generalized malaise from the time he woke up on 15Jan2021 at 03:00AM after the second dose that has completely resolved when all his other symptoms resolved yesterday (17Jan2021). No any AEs require a visit to physician or ER. Therapeutic measures were taken as a result of the events. The outcome of events Injection site pain and arm soreness was recovered on 15Jan2021. The outcome of other events was recovered on 17Jan2021. Relatedness of drug to reaction(s)/event(s) was reported related.
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| 58 | 2021-02-01 | pain in extremity |
mild numbness of teeth and tongue; mild numbness of teeth and tongue; heaviness of head; I was very ...
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mild numbness of teeth and tongue; mild numbness of teeth and tongue; heaviness of head; I was very tired; arm pain lasted 2 days; This is a spontaneous report from a contactable Other HCP. This Other HCP reported himself that the 58-year-old male patient received second dose of bnt162b2 (COVID 19, Pfizer), via Intramuscular on 11Jan2021 10:00 AM on Left arm at single dose for covid-19 immunisation. Medical history included history of mitral valve repair and pacemaker. Known allergies was not known. Concomitant medications included Metoprolol 25 mg, Baby aspirin 81 mg, Antihistamine( Certizine hidrocloride 10mg,Costco brand). The patient previously took first dose of bnt162b2 (COVID 19, Pfizer), via Intramuscular on 21Dec2020 10:00 AM on Left arm at single dose for covid-19 immunisation. No other vaccine in four weeks. Side effect occurred after his 2nd dose (11Jan2021) he was feeling mild numbness of teeth and tongue heaviness of head after 30 minutes of vaccine. It lasted 5-6 hours, also he was very tired, and arm pain lasted 2 days. The events started from 11Jan2021 10:00 AM. The outcome of the events feeling mild numbness of teeth and tongue, heaviness of head was recovered on 11Jan2021. The outcome of the other event was recovered in Jan2021. No Covid prior vaccination. Covid tested post vaccination. covid test post vaccination included Rapid test on 09Jan2021 with covid test result: Negative. Information on the lot/batch number has been requested.
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| 58 | 2021-02-03 | bell's palsy, facial paralysis |
Had 1st COVID-19 vaccine (pfizer) 1/5 1/13 noticed right lower eyelid started twitching (this is not...
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Had 1st COVID-19 vaccine (pfizer) 1/5 1/13 noticed right lower eyelid started twitching (this is not a new issue for him and frequently happens when fatigued) 1/20 sharp intermittent pain in right inner hear pinna which stopped 1 week ago 1 week ago noted some slight right facial droop which has persisted 2nd vaccine given 1/26 (prior to him seeking care for symptoms) He was seen in my office on 1/29 where he was treated for Bells Palsy.
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| 58 | 2021-02-03 | pain in extremity |
Injection site pain; Arm pretty sore; This is a spontaneous report from a contactable physician who ...
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Injection site pain; Arm pretty sore; This is a spontaneous report from a contactable physician who reported for himself. A 58-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot #: EJ1685) via an unspecified route of administration on 23Dec2020 at 09:00 (at the age of 58-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history included a history of anaphylaxis to latex which predated treatment with the Pfizer COVID-19 vaccine, heart rate control, hypertension and high cholesterol; all from unspecified dates and unspecified if ongoing. It was also reported that the patient's medical history was "none" and that the patient had no illness at the time of vaccination. Family medical history was reported as "none". Concomitant medications included ongoing metoprolol taken for heart rate control taken from an unspecified date ("taking for two years"), ongoing telmisartan taken for hypertension orally from an unspecified date ("taking for two years") at 1x/day (take once daily by mouth) and ongoing rosuvastatin calcium (CRESTOR; strength: 40mg) taken for high cholesterol from an unspecified date ("taking for 10 years") at 40mg, 1x/day. The patient did not receive any additional vaccines on the same date of the COVID-19 vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Dec2020 the patient experienced "injection site pain" and "arm pretty sore". It was reported that "a physician called regarding the Pfizer COVID-19 vaccine. The patient reported that he received the second dose of the vaccine on Thursday and was advised by his medical director to call Pfizer to report his symptoms. He reported that he received the first dose of the Pfizer COVID-19 vaccine three weeks prior to the second dose. The patient first stated that was about 14Dec2020, but then clarified that per his vaccine card, he received the first dose of the vaccine on 23Dec2020 at 0900AM in the left arm. The patient stated that he noticed injection site pain that lasted about two days and his arm was pretty sore. Both events completely resolved before the second dose." It was reported that the events did not require a visit to the physician or to the ER. It was reported that there were no relevant tests. The clinical outcomes of the events "injection site pain" and "arm pretty sore" were both recovered/resolved on 15Jan2021. The reporter considered that there was reasonable possibility (method of assessment: Global introspection) that the events "injection site pain" and "arm pretty sore" were related to BNT162B2.
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| 58 | 2021-02-04 | pain in extremity |
Sore arm; mild fatigue for 24 hours; mild shortness of breath upon exertion (persists); cough began ...
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Sore arm; mild fatigue for 24 hours; mild shortness of breath upon exertion (persists); cough began within 1 hour of 2nd vaccination; This is a spontaneous report from a contactable nurse, the patient. A 58-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number EL3248), via intramuscular route in the right arm on 19Jan2021 16:30 as a single dose for COVID-19 immunization. Historical vaccine data included the first dose of BNT162B2 on 29Dec2020 at 16:30 (at the age of 58-years) via intramuscular route in the right arm. Medical history included rheumatoid arthritis. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included tofacitinib citrate (XELJANZ XR), methotrexate, atorvastatin (LIPITOR), lansoprazole (PREVACID), and celecoxib (CELEBREX). The patient had not received any other vaccine within 4 weeks prior to the vaccine. On 19Jan2017 at 17:30, the patient experienced sore arm, cough began within 1 hour of 2nd vaccination and persisted 2 days later, mild shortness of breath upon exertion which persisted, and mild fatigue for 24 hours. The patient did not receive any treatment for the events. The patient was not tested for COVID-19 post vaccination. The clinical outcome of the events sore arm, fatigue, shortness of breath, and cough was reported recovering. No follow-up attempts are possible. No further information is expected.
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| 58 | 2021-02-07 | face paralysis, facial paralysis | Bell' Palsy . Right side facial weakness. Sudden onset ten days after vaccine. |
| 58 | 2021-02-10 | numbness |
Facial numbness around right eye; This is a spontaneous report from a contactable physician (patient...
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Facial numbness around right eye; This is a spontaneous report from a contactable physician (patient). A 58-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular first dose (lot number: EH9899) on the left arm on 26Dec2020 07:15 and the second dose (lot number: EL1283) on the left arm on 25Jan2021 07:15 at a single dose for COVID-19 immunization. Medical history included allergies, high cholesterol; known allergies: dust, pollen, trees, grasses. Concomitant medication included ubidecarenone (COQ10 [UBIDECARENONE]), colecalciferol (VITAMIN D [COLECALCIFEROL]), fexofenadine, atorvastatin calcium (ATORVASTIN), montelukast and multivitamins. The patient experienced facial numbness around right eye and migrating 11 hours after injection. Similar sensation 2 weeks after first vaccination in Jan2020. No treatment was received for the event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. Outcome of the event was unknown.
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| 58 | 2021-02-10 | pain in extremity |
Pain in arm spreading to torso. Shooting pains in torso and upper legs. Fatigue, headache. Symptoms ...
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Pain in arm spreading to torso. Shooting pains in torso and upper legs. Fatigue, headache. Symptoms started 12 hours after vaccination, and persisted until 36 hours.
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| 58 | 2021-02-16 | weakness |
Immediately experienced chills; elevated pulse/heart rate and low oxygen; elevated fever; pulse/hea...
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Immediately experienced chills; elevated pulse/heart rate and low oxygen; elevated fever; pulse/heart rate went to 120; fever went to 102.5; and oxygen at 94. After 4 hours, metrics returned to within normal range. Weak and tired the rest of evening and into the next day.
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| 58 | 2021-02-20 | tremor |
Onset of sweating, lightheadedness, dizziness, shakiness, about 5 minutes after vaccination. Taken t...
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Onset of sweating, lightheadedness, dizziness, shakiness, about 5 minutes after vaccination. Taken to medical area, BP 180/100s, HR 90, Temp normal. Exam normal except for hand tremors. Minimal liquid and no food intake in last 24 hours. POC glucose 96 a minute or two after eating crackers. Given more food and water. Initial symptoms improved but continued hand tremors and persistent hypertension to high 170s/high90s for over 1 hour, HR 70s. One BP 160s/90s HR 60 but then back to BP systolic 170s. Transferred patient to local emergency room for further evaluation. Patient reported that he was discharged from ED after several hours that evening.
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| 58 | 2021-02-24 | flushing |
Lightheaded and flushed, slightly dizzy when standing. 3:56pm evaluated by EMS. BP 140/92, HR-98,...
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Lightheaded and flushed, slightly dizzy when standing. 3:56pm evaluated by EMS. BP 140/92, HR-98, O2-98% on room air. 4 pm so resolved and discharged.
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| 58 | 2021-02-26 | burning sensation, cold extremities, tingling, pain in extremity |
No initial symptoms other than sore arm at injection site which lasted for about 23 hours. On Januar...
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No initial symptoms other than sore arm at injection site which lasted for about 23 hours. On January 28 in the middle of the night woke up with pain in left hand. Could not move left hand. Was sleeping on back - not on arm or hand. No restricted blood-flow. Massaged hand and it became responsive. This was followed by burning and tingling sensation in hand. Hand was cold to touch first day. Burning and tingling and muscle tension increased for first couple days. Would be intermittent and location varied. Hands and feet most common. Left back scapular area and left pectoral muscle common. Muscle tightness would cause joint pain without signs of any redness. No temperature. No discoloration. Not as bad in middle of the day. After a few days. When second shot was administered on February 9 at 12:10 AM went home and all sensations stopped for about 12 hours. Took Tylenol with some benefit to diminish but not end symptoms. In past few days have read about taking antihistamines which has often helped. Symptoms are not as intense as they started out to be, but they continue to linger. Muscle tightness has largely given way to fluttering sensation or paresthesia and burning is mostly in bottom of left foot only. Any muscle tightness can be rubbed out (massage) for the most part. Occasional joint tightness continues in fingers - crack knuckles and it improves.
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| 58 | 2021-02-27 | pain in extremity |
Next day had sore left arm 2 days after injection had mild nausea, mild fever and moderate headache ...
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Next day had sore left arm 2 days after injection had mild nausea, mild fever and moderate headache 3 days woke with all symptoms gone except one new symptom - very red conjunctivitis - left eye red cornea
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| 58 | 2021-03-01 | numbness |
Tongue and right side of face went numb within minutes of receiving in right arm. Continued getting ...
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Tongue and right side of face went numb within minutes of receiving in right arm. Continued getting worse. After getting home, I waited 2 hours and took Benadryl and went to bed. Morning still numb but better. Feels like I can?t taste on that side. Also have a headache and just overall feeling lethargic.
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| 58 | 2021-03-01 | paralysis |
Pt reported he got the second COVID vaccine at 8:33 am at the Center at an event run by Health Clin...
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Pt reported he got the second COVID vaccine at 8:33 am at the Center at an event run by Health Clinic. At 10 am he began to feel unwell describing "disorientation" which upon further explanation seems he is describing difficulty with his proprioception, ie not able to tell where his body is in space, and disequilibrium, ie having to stop and hold on to something while walking. This lasted most of the day and subsided by evening. He has continued to have ongoing shorter episodes 3-4 times per day lasting 5-10 minutes. In addition he has noted increasing weakness in his right thigh, particularly when going from sitting to standing and the through swing while walking. He describes these as "paralytic attacks" that occur once or twice per day and last hours. Both symptoms are similar to those he had post CVA in 2019 and greatly improved with PT and home exercises. In addition he has noted fecal urgency and fecal incontinence in the last couple of weeks, he is unsure if this is directly related to the vaccine.
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| 58 | 2021-03-02 | feeling hot |
103 degree fever; chills; body aches; headache; feeling hot through the night; Got sick; This is a s...
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103 degree fever; chills; body aches; headache; feeling hot through the night; Got sick; This is a spontaneous report from a contactable consumer (the patient). A 58-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not provided, expiry date May2021), via an unspecified route of administration in the left arm on 30Jan2021 10:00 (at the age of 58-years-old) as a single dose for COVID-19 immunization; and apixaban (ELIQUIS, lot number ABA8272S, NDC 0003089421, expiry date Oct2021) film-coated tablet, via an unspecified route of administration from an unspecified date to 31Jan2021 at 5 mg, twice daily for cerebrovascular accident prophylaxis. Medical history included: he had tested positive asymptomatically for COVID due to contact contamination on 02Jan2021 or 03Jan2021, blood pressure, and A-fib (atrial fibrillation). Concomitant medication included ongoing metoprolol for blood pressure. There were no vaccines administered on same date with the Pfizer vaccine. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient stated that he got sick after getting the vaccine (on 30Jan2021) and had an important question. He got a fever (31Jan2021) and all that stuff that lasted like a day and a half after getting the vaccine, just like a million other people. But he missed the part about asking a doctor about taking his blood thinner, which he took as normal up through the day that he got the vaccine and the next morning, then he stopped it. The patient clarified that he got the vaccine on Saturday (30Jan2021), stopped the blood thinner on Sunday (31Jan2021), the sickness subsided around Monday (as reported), but he still hasn't gone back on the blood thinner. He wanted to know when it was safe for him to start taking the blood thinner again, and he needed to know what to do for the second vaccine. The clinical course was as follows: He got the first dose of the vaccine on 30Jan2021 at 10:00 and at 22:00 he started feeling hot through the night. On Sunday, 31Jan2021, he had 103 degree fever, chills, body aches, and a headache. He clarified that he recovered completely by Wednesday, 03Feb2021. He had been on Eliquis for years for A-Fib. He stopped taking it once he got sick after getting the vaccine and went back and read the material and noticed what it said about the blood thinner. He did not go to the emergency room or physician's office. The action taken in response to the events for apixaban was temporarily withdrawn. The outcome of the events was recovered on 03Feb2021. Follow-up (05Feb2021): This is a spontaneous report from a contactable consumer based on information received by Pfizer from Bristol-Myers Squibb (manufacturer control number US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-013684), license party for apixaban (ELIQUIS). This case was received via Pfizer Inc (Reference number: #) on 05Feb2021 and was forwarded to BMS on 09Feb2021. This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (103 degree fever), CHILLS, PAIN (bodyaches) and HEADACHE in 58-year-old male patient who received apixaban (Eliquis) film-coated tablet (batch no. ABA8272S) for Cerebrovascular accident prophylaxis. CO-SUSPECT PRODUCTS included Covid-19 Vaccine injection for COVID-19 immunisation. Concurrent medical conditions included Blood pressure abnormal. On an unknown date, the patient started Eliquis (batch no. ABA8272S) (unknown route), 5 milligram twice a day. On 30Jan2021, the patient started Covid-19 Vaccine (unknown route) Unknown dose by injection in left arm. On 31Jan2021, an unknown time after starting Eliquis, the patient experienced PYREXIA (103 degree fever), CHILLS, PAIN (bodyaches) and HEADACHE. Eliquis (Unknown) was interrupted due to event. On 03Feb2021, PYREXIA, CHILLS, PAIN and HEADACHE resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31Jan2021, Body temperature: 103 degree. For Eliquis (Unknown), the reporter did not provide any causality assessments. Information about lot/batch number has been requested.
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| 58 | 2021-03-04 | facial paralysis, face paralysis |
PRESENT OF FACIAL PARALYSIS ON THE RIGHT SIDE OF THE FACE AFTER THE SECOND DOSE OF THE VACCINE. LO...
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PRESENT OF FACIAL PARALYSIS ON THE RIGHT SIDE OF THE FACE AFTER THE SECOND DOSE OF THE VACCINE. LOSS OF STRENGTH RIGHT SIDE OF THE FACE FROM EYE TO THE MOUTH. I CAN NOT MOVE THE LIPS AND CLOSED THE RIGHT EYE.
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| 58 | 2021-03-06 | numbness |
Within a minute of receiving vaccine I felt a very cold lump/ feeling in my throat that got worse ov...
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Within a minute of receiving vaccine I felt a very cold lump/ feeling in my throat that got worse over the next few minutes making it difficult to swallow. At the same time I felt very fuzzy and numb all over my face and body and very light headed. My arms and legs felt very heavy. The EMT took my blood pressure and told me it was 174/125. My normal BP is 110/60. I have had my BP taken once a month over last 20 years at my monthly pain center appointments. They hooked me up to a 4 lead cardiac monitor and said I had A -Fib. They then hooked me up to a 12 lead ekg monitor and said I didn?t have A-Fib. I have had 3 EKG?s in last year because I was scheduled to have total knee replacement surgery which was rescheduled 2 times and all 3 EKG?s were completely normal. After about 1 hour my symptoms improved to the point where I could go home. I Have had between 20-30 knee procedures over the last 40 years and my reaction to the vaccine felt exactly like I was being put to sleep by sodium pentothal or a very high dose of Versed.
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| 58 | 2021-03-09 | tremor | Shaking, Confusion, Head Ache |
| 58 | 2021-03-10 | pain in extremity |
I had a single red blotch on my right ankle appear the day after my first vaccination. I did not com...
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I had a single red blotch on my right ankle appear the day after my first vaccination. I did not complete an adverse reaction form for it because I was not sure it was related. When I got my second dose, I did not experience any reaction other than a sore arm until three days later. I developed red blotches/hives on my arms, legs, and torso (front and back). I took two Benadryl on Sunday morning and two more that night. They tended to go away and then others would pop up in other locations of my body. The Benadryl did not seem to have any significant affect. I was very itchy for several days. i went to see my doctor on the 5th day since it occurred over the weekend and I had an epi pen if I needed it. It was getting better when I saw her so I didn't want anything other than a topical, which didn't come in to the pharmacy until they cleared up. I stopped itching by Monday and they were pretty well gone by Wednesday, which was 7 days later. I took photos of the spots.
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| 58 | 2021-03-13 | muscle spasms, muscle twitching, feeling cold |
Ihave high blood pressure. I became light headed after 10 minutes of receiving vaccine. Doctor told ...
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Ihave high blood pressure. I became light headed after 10 minutes of receiving vaccine. Doctor told me it lowers blood pressure. My blood pressure was low all day. The next day my blood pressure was still not right and I was cold and could not warm up and it was 75 degrees in the house.I had mild spasms and twitches.
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| 58 | 2021-03-14 | numbness, one side paralysis |
Patient woke up the morning following vaccine administration with numbness and weakness of his right...
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Patient woke up the morning following vaccine administration with numbness and weakness of his right arm and hand. He later woke up from a nap that afternoon with numbness and weakness also in his right leg.
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| 58 | 2021-03-15 | flushing |
Pt came back into clinic on 3/16/2021 to ask if we would submit an adverse event request. Pt waited ...
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Pt came back into clinic on 3/16/2021 to ask if we would submit an adverse event request. Pt waited 15 minutes and had no reaction in clinic and then on drive back home pt states that his face became flush, he began having shortness of breath, and palpitations. Pt states that he pulled of onto side of road and waited approximately 15 minutes and then symptoms began to dissipate. Pt has had no further symptoms and the symptoms he states that he had were unwitnessed by medical staff at clinic. Once again pt waited till 3/16/2021 to report this to the clinic.
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| 58 | 2021-03-16 | pain in extremity, numbness |
Severe left arm pain for 2 weeks after injection. Left lateral numbness on the outside of left leg j...
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Severe left arm pain for 2 weeks after injection. Left lateral numbness on the outside of left leg just above, through, and below the knee.
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| 58 | 2021-03-17 | pain in extremity |
I became a little light-headed about 30 minutes after the shot it lasted about 30 minutes. And about...
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I became a little light-headed about 30 minutes after the shot it lasted about 30 minutes. And about 9:00 p.m. my arm got a little sore and then increased about twice as bad as a flu shot does cleared up in about 24 hours.
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| 58 | 2021-03-18 | weakness, numbness |
The first sign was numbness in my chin and cheeks which would come and go. The next sign was muscle...
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The first sign was numbness in my chin and cheeks which would come and go. The next sign was muscle pain followed by severe joint pain followed by nausea,and a loss of appetite.The next sign was chills and weakness.This went on for a day and a half and went away .During this time I took extra strength tylenol
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| 58 | 2021-03-18 | migraine |
I developed a headache about an hour after the shot. It was like a migraine type headache. I took 2-...
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I developed a headache about an hour after the shot. It was like a migraine type headache. I took 2- 500 mg Tylenol tablets about 7 PM. Hard to get to sleep but finally slept about 6 hours and woke up with no more headache and have felt fine ever since.
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| 58 | 2021-03-18 | unresponsive to stimuli, flushing | Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild |
| 58 | 2021-03-20 | weakness, pain in extremity |
Low fever, body aches, joint pain, diarrhea, headache, sore arm. Began within 3 hours of shot, laste...
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Low fever, body aches, joint pain, diarrhea, headache, sore arm. Began within 3 hours of shot, lasted the rest of that day, night, and the next day. Still feeling weak and feverish at present time.
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| 58 | 2021-03-20 | feeling hot |
Body rash appears after 33hours; feels very hot; itchy; This is a spontaneous report from a contacta...
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Body rash appears after 33hours; feels very hot; itchy; This is a spontaneous report from a contactable consumer, the patient. This 58 year old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN9581), dose 1, single dose, via an unspecified route of administration in the left arm on 08FEB-2021 at 10:45 (at the age of 58 years-old) for COVID-19 vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. There was no relevant medical history reported. Historical vaccine included flu shot on 18Jan2021. Concomitant medications included calcium sulfate dihydrate, dryoptieris crassirhizoma rhizome, ephedra Spp, herb, forsythia suspensa, glycyrrhza glabra root, houttuynia cordata herb, isatis tinctorial root, lonicera Japonica flower, menthol, pogostemom cablin herb, prunius SPP, seed, rheum SPP, rhodiola crenulate (LIAN HUA QING WEN) capsules. On 10Feb2021 at 15:00, the patient experienced body rash after 33 hours, was itchy and very hot. No treatment was received for body rash, itchy and very hot. The clinical outcome of body rash, itchy and very hot was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 58 | 2021-03-20 | tremor |
Developed fever of 101-103, violent chills, uncontrolled shaking and extreme headache. Lasted 3 sol...
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Developed fever of 101-103, violent chills, uncontrolled shaking and extreme headache. Lasted 3 solid, then fever began to drop day 4, but headache persisted along with sweats and violent chill. No real appetite. Also experienced body ache, but not as bad as other symptoms. No, or little bowel movement during this time. On day five (today) urine output is dark, but went 18 hours without Tylenol. Piot to that i need 2 extra strength Tylenol every 5 hours for 4 days straight. No nausea or vomiting associated with any of this. I have extreme fatigue due the extreme headache pain keeping me awake. Headache on the left and right side of the head, not front or behine the eyes, more over the ears. Today I just feel wiped out by it all, but much improved. I have never had any reaction to any vaccines previously, including allergy, flu, shingles and pneumonia.
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| 58 | 2021-03-22 | pain in extremity |
Right Foot started hurting the night after the vaccine. The next day, it hurt to walk on it. Mainly...
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Right Foot started hurting the night after the vaccine. The next day, it hurt to walk on it. Mainly around the base of my 2nd and 3rd toes. The next day it hurt so bad I couldn't walk on it and saw the doctor. A red area had developed on top of my foot at the base on my toes. Doctor though could be Gout but didn't really look like it and usually that is in the big toes. Plus the timing of this issue and my vaccine were suspect. Had X-ray on that Friday, two days after vaccine and everything looked fine they said. I was prescribed Celebrex and over the weekend took two per day due to the pain. I stayed in bed all weekend and pain got worse before taking another dose of medicine which helped for a while. Swelling continued to be about the same or a bit more and the redness moved over to my big toe and then up my foot around towards the right side. Today my right side of foot is really soar now as well and still can't walk on it and still swollen. Doctor at a urgent care sports medicine location prescribed me Prednisone steroid to see if that helps. But so far 5 days after vaccine and my foot is still swollen, red across the top and so painful it keeps me up at night and I can't walk on it. I'm hoping the steroids work.
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| 58 | 2021-03-23 | weakness |
On 3-11-21 at 0930, I developed low grade headache up neck over top left side of head in morning, by...
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On 3-11-21 at 0930, I developed low grade headache up neck over top left side of head in morning, by 1300 hours I felt very crappy similar to how it feels days after a fever breaks when having the influenza. At bedtime 3-11-21, I had a fever 100.1. At 0100, fever rose to 101.1. At 0500 fever rose to 102.6. During day on 3-12-21, I felt like I had the flu, fever broke mid-morning. on 3-13-21, I felt OK. On 3-15 and 16, I felt like I generally like I had a flue bug. I felt better days later and then around March 21-24th I've had a pretty continuous headache and neck ache which I have not had before the vaccine. Lack of energy and feeling crappy. Scheduled for second vaccine April 2nd.
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| 58 | 2021-03-24 | nerve pain |
Developed itchy rash-like symptoms on torso, arms, hands, neck, and face, as well as upper back, and...
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Developed itchy rash-like symptoms on torso, arms, hands, neck, and face, as well as upper back, and legs. Nerve inflammation, also.
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| 58 | 2021-03-24 | tremor |
I have had Post Acute Covid-19 syndrome since Nov 4, 2020. The first night after receiving my firs...
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I have had Post Acute Covid-19 syndrome since Nov 4, 2020. The first night after receiving my first vaccine I got the chills about 16 hours after my shot went away after a few hours. Woke of the next day with my post acute syndrome symptoms much worse than I had prior to shot, my fatigue in my legs were to the point I could hardly walk, my brain fog and tremors were much worse, that lasted about 1 day then the next two nights I woke up in the middle of night with severe sweating. I was then felling like I had before the shot. Then about 4 days after receiving the vaccine the post acute syndrome symptoms again were much worse than before. This last for about 2 weeks then gradual worked back the my original feeling of fatigue, brain fog and tremors that I had prior to vaccine
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| 58 | 2021-03-25 | bell's palsy | Bells Palsy |
| 58 | 2021-03-27 | weakness, tremor |
Received first Pfizer Covid19 vaccine on 2/28/21. Developed fever 102.8, chills, SOB on 3/2/21 and w...
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Received first Pfizer Covid19 vaccine on 2/28/21. Developed fever 102.8, chills, SOB on 3/2/21 and was transported by EMS to ER and admitted. He was tested 3 times for COVID 19 and found to be negative. CT scan was concerning for viral pneumonia and suspected COVID. He was treated and released to home on 3/4/21. Followed by pulmonologist. Received second Pfizer COVID19 vaccine on 3/21/21. On 3/23/21 developed fatigue, weakness, shakiness, nausea and vomiting. had significant decline over the week. Has acute event on 3/27/21 and was pronounced dead at home.
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| 58 | 2021-03-27 | weakness |
Ongoing headaches, severe at times along with nausea and dizziness. Some days it is completely de...
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Ongoing headaches, severe at times along with nausea and dizziness. Some days it is completely debilitating. These started about a week after second shot. They have continued with some days being less present. I also have been learning to cope with symptoms.
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| 58 | 2021-03-27 | cold sweat |
Dizziness, shortness of breath, cold sweats, fatigue, unsteady on feet, feeling of heart racing, sev...
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Dizziness, shortness of breath, cold sweats, fatigue, unsteady on feet, feeling of heart racing, severe vomiting, total exhaustion. These symptoms were severe, much worse than when I had the virus in December. I thought I was having a stroke and was minutes away from dialing 911.
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| 58 | 2021-03-27 | involuntary muscle movements |
Vaccinated at 12:20pm. At approx 12:34 pt told wife he felt faint, was sitting in observation area i...
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Vaccinated at 12:20pm. At approx 12:34 pt told wife he felt faint, was sitting in observation area in drivers seat of his own vehicle. Had brief syncopal episode witnessed by his wife with jerky motions of legs and arms lasting a few seconds. Patient awoke immediately with memory of event, was oriented and remember events leading up to being vaccinated. No incontinence. Car seat reclined. Reports no pain, pt appeared pal but no diaphoretic. BP 140/82, P 64 regular RR 14 unlabored. Oxygen sat 98%. EMS called, patient refused transport to hospital but agreed to follow up with primary care provider. Wife sis he was very anxious about his vaccine.
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| 58 | 2021-03-28 | cold sweat | Cold sweat, dizziness, tachycardia, headache, persists after 24 hours but not as much |
| 58 | 2021-03-29 | bell's palsy | Systemic: Bell's Palsy-Medium |
| 58 | 2021-03-29 | bell's palsy | bells palsy seen at ER on 03-26-21; treated by ER physician with prednisone, valtrex |
| 58 | 2021-03-29 | cold sweat, tenderness |
Swelling at injection site immediately after injection. Slight light-headedness Vital Signs: BP 180...
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Swelling at injection site immediately after injection. Slight light-headedness Vital Signs: BP 180/96 HR 86 O2sat 98% Skin Signs: Warm and dry, Clammy, other: swelling at injection site Circulation: Cap refill <2sec Respiratory: Breath and sound clear bilaterally Initial Treatment: Observed swelling marked out original size checked for enlargement or skrinking. 1:48 PM: BP 160/96 HR 86 O2sat 98% Skin Signs: Cool and dry, clammy, diaphoretic, other: plush 2:08 PM: BP 156/104 HR 93 O2sat 96% Skin Signs: Warm and dry (neck/head), cool and dry (arms) 2:30 PM: BP 142/100 HR 90 O2sat 96% Up and walking, no dizziness of pink warm dry, alert x3 continues to have decreasing swelling in left deltoid, tender to touch, decreasing redness at site, attempted to call wife x2 and friend x1 Disposition: Other: Pt will wait for friend who will follow pt in his car to where he will meet up w/ wife. Pt advised to notify PCP of rxn to vaccine and to notify future vaccinators of this fact.
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| 58 | 2021-03-29 | numbness |
Approximately 45 minutes after receiving the shot I started experiencing some mild tingling/burning ...
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Approximately 45 minutes after receiving the shot I started experiencing some mild tingling/burning in my right shoulder (at the injection site). Shortly afterwards, I also noticed swelling and numbness in my hands and face. The swelling in my hands increased to the point where my ring finger on my left hand began throbbing. The ring is already tight due to weight gain, but I became concerned that I may need to cut the ring off. Throbbing plateaued and continued for about an hour then subsided. Swelling and numbness also plateaued and subsided, though those took longer (about 2 days). Overall, it felt a bit like the time I discovered that I was allergic to shrimp/lobster/crab but it did not progress to the same level (no trouble breathing with this episode).
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| 58 | 2021-03-29 | tingling, numbness |
Numbness and tingling in the ring finger and little finger on left hand. Treatment included OTC anti...
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Numbness and tingling in the ring finger and little finger on left hand. Treatment included OTC anti-inflammatory, and stretching to reduce common symptoms of ulnar nerve entrapment. Condition has not lessened in 28 days.
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| 58 | 2021-03-30 | muscle spasms |
I started having some joint pain in my knees and a little in my fingers and then got back spasms. B...
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I started having some joint pain in my knees and a little in my fingers and then got back spasms. Back spasms may have been a result of the joint pains. On a pain scale of 1-10 with 10 being severe, I'd say it was a 4 although the back spasms were much higher. Just wanted to document this.
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| 58 | 2021-03-31 | pain in extremity |
Arm pain both at injection site and also ache throughout left arm. Pain was more intense on day a...
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Arm pain both at injection site and also ache throughout left arm. Pain was more intense on day after the injection. (Wednesday 03/31). By. Thursday, 04/01, the pain was reduced and was very subtle.
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| 58 | 2021-04-01 | seizure |
1st dose Pfizer administered at 0940 at clinic. patient experienced no reactions or symptoms during ...
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1st dose Pfizer administered at 0940 at clinic. patient experienced no reactions or symptoms during observation period at the clinic. Patient had been home for approximately 2 hours when he started experiencing some chest pain prior to his seizures around 1210. He does have a history of seizures which are uncontrolled ranging from having them twice a week to twice a month. patient reports the seizures were no worse than any other seizure he has had in the past. The seizures lasted periodically for approximately 20 minutes. patient reports he didn't consult with his PCP or neurologist prior to the vaccine. The patient was encouraged to seek medical treatment if symptoms persist or worsen over the next hours. He was also encouraged to reach out to his neurologists prior to the second dose.
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| 58 | 2021-04-01 | speech disorder |
At 1300 on March 26 I received the shot in my left arm. I went back to work after receiving the vacc...
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At 1300 on March 26 I received the shot in my left arm. I went back to work after receiving the vaccine I returned to work. At 1720 I was at home and started itch all over my, arms legs, and stomach. Broke out in a rash on my stomach and chest. At 1830 my tongue was swelling and had a hard time speaking. I call a friend and told her. She told me to take some Benadryl. I did. I then went to bed. My friend came over at about 2100 because she was worried and found me in bed. My breathing was off and she tried to wake me. She called 911 and I was transported to the hospital. I am now in rehab with undetermined results as to what happened.
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| 58 | 2021-04-02 | tremor, weakness, flushing |
Systemic: Chills-Mild, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Medium, Syste...
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Systemic: Chills-Mild, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Severe, Systemic: Hypertension-Severe, Systemic: Hypotension-Severe, Systemic: Nausea-Mild, Systemic: Shakiness-Medium, Systemic: Visual Changes/Disturbances-Severe, Systemic: Weakness-Mild
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| 58 | 2021-04-02 | tremor, muscle twitching, flushing, feeling hot |
the right side of my neck begin to start hurting if I turn my head forward or sideways/general neck ...
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the right side of my neck begin to start hurting if I turn my head forward or sideways/general neck pain/also tender across the entire neck area; warm to touch; stabbing pain; muscular twisting; constant feeling of flushing; shaking/severe shaking at night; chilling; profuse sweating; This is a spontaneous report from a contactable healthcare professional (patient). A 58-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry were not reported), via an unspecified route of administration, administered in left arm on 19Mar2021 17:00 (at the age of 58-years-old) as single dose for covid-19 immunisation. The vaccination facility type was reported as other. No other vaccine in four weeks. The patient was not covid tested post vaccination. Medical history included neck and back injuries, and covid prior vaccination: Yes. The patient had no known allergies. Concomitant medication included gabapentin (NEURONTIN). On 19Mar2021 at 17:45 (approximately within one hour of the injection), the right side of the patient's neck begin to start hurting if he turned his head forward or sideways. It was warm to touch and also tender across the entire neck area. This only turned into a more severe that was excruciating one turning head in any direction. As well as lying down the patient had to sleep sitting up in a recliner. With absolutely no relief all the pain the stabbing pain and muscular twisting and general neck pain additionally there was a constant feeling of flushing but at the same time shaking and chilling with severe shaking at night and profuse sweating. Treatment included ibuprofen (MOTRIN), paracetamol (TYLENOL) to tizanidine. The events resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. The outcome of the events neck pain, pain and muscle twitching was not recovered while for the remaining events was recovering. Information on the lot/batch number has been requested.
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| 58 | 2021-04-03 | pain in extremity | Extreme pain in arm feels deep inside hurts bad. |
| 58 | 2021-04-03 | cold extremities |
Joint aches and pains, headache, fatigue, coldness in my hands and feet. Symptoms lasted about 20 h...
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Joint aches and pains, headache, fatigue, coldness in my hands and feet. Symptoms lasted about 20 hours, with a bit of residual fatigue and odd feelings for about 1 more day.
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| 58 | 2021-04-06 | numbness, tremor, cold extremities |
Within 15 minutes, felt extremely tired. This was the same response when taking the 1st shot, howe...
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Within 15 minutes, felt extremely tired. This was the same response when taking the 1st shot, however, it didn?t seem as bad. After waiting 30 minutes, began driving home, but within 10 minutes, began to feel like heart was racing, and whole body was kind of numb feeling. I did check heart with my watch which only showed 89bpm. After another 10 minutes, I arrived home, and I was shaking uncontrollably and my hands and feet were cold. Temp was only 97.4. After another 20 minutes, the symptoms all went away.
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| 58 | 2021-04-06 | muscle spasms, tingling, pain in extremity |
Fever, fatigue, headache,lung congestion,eye pain,hand and feet pain(cramps needle/pins poking)eyes ...
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Fever, fatigue, headache,lung congestion,eye pain,hand and feet pain(cramps needle/pins poking)eyes blurred,sleepness
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| 58 | 2021-04-06 | tremor, inability to speak, speech disorder |
I woke at 6:30am on 04/07/2021 in a state of complete confusion and disorientation. It was a level ...
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I woke at 6:30am on 04/07/2021 in a state of complete confusion and disorientation. It was a level of disorientation I have never experienced before in my lifetime. I fainted one time and was having extreme difficulty getting my bearings and walking and was simply in total "mental disarray". I was having difficulty producing words, a prolonged stutter, you might say. I was shaking. The local paramedics came and I was taken to the local ER. Because I was having difficulty speaking, the paramedics (and later the physicians) thought I might have had a TIA. An MRI on 04/07/2021 at 5pm produced a negative result. So i can only attribute my reaction to the vaccine. It was very significant, and i thought it made sense to report it.
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| 58 | 2021-04-07 | weakness | Fever & chills Lack of energy Headache |
| 58 | 2021-04-07 | pain in extremity |
Bad gout flare-up, worst symptoms and longest lasting flare-up to date. Three days of intense pain ...
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Bad gout flare-up, worst symptoms and longest lasting flare-up to date. Three days of intense pain in left knee, ankle, and foot 4/1-3. Whole leg was swollen and currently (4/8) ankle and foot are still swollen and achy. Low-mid grade fever from 4/1 to 4/6. Still experiencing fatigue. Consulted primary care physician, 4/8, and may do a video visit next week if symptoms persist.
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| 58 | 2021-04-09 | weakness |
passed out/unconscious; feel weak; dizzy; not normal; This is a spontaneous report from a contactabl...
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passed out/unconscious; feel weak; dizzy; not normal; This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in arm left on 26Mar2021 09:45AM (Lot Number: ER8730) as single dose for COVID-19 immunisation. The patient had COVID prior vaccination. The patient had no other medical history or known allergies. The patient's concomitant medications were reported as none. The patient did not have COVID test post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After taking the vaccine the patient waited for 15 minutes prior to departing the facility in order to make sure there was no adverse reactions. At approximately 10:15 10:30 AM the patient drove back home. After driving for about five minutes while stopped at a traffic light the patient completely passed out at 10:45, he was unconscious for approximately 2 to 3 minutes, almost crashed his car and EMT support had to be called. The patient regained his conscience but it took him over a half hour to feel 50% better. Until 8:30 PM 26Mar2021, the patient still felt weak and dizzy and not normal. No treatment was received for events. The outcome of events was recovering.
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| 58 | 2021-04-09 | feeling cold, feeling hot |
11 hours after shot (Sat 3/27/21 2:00am): Chills, high temp & hallucinations, then hot, neck, back, ...
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11 hours after shot (Sat 3/27/21 2:00am): Chills, high temp & hallucinations, then hot, neck, back, arms & legs muscles tightened, freezing for a few hours. 8:00a: wiped out. 1:00pm (Sat): chills, hot, body aches, upset stomach, slept on/off until 4 or 5pm when I started shivering, vomiting, some hallucinating. Armpit glands felt twisted and pulled. I felt worse & asked my wife to call 911. Paramedics came, took vitals, blood, offered to take me to hospital (didn?t go). They stayed an hour until I felt stable. Sun 3/28/21am, exhausted, slightly better but my mind was spacey, body achy & armpits hurt. 12:00pm: noticed short term memory loss, ate a few crackers, drank water, napped on/ off, went to bed around 900pm. Mon, 3/29/21, still achy and mentally fuzzy. Side effects diminished over a few days.
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| 58 | 2021-04-09 | one side paralysis |
I hadn't been feeling well. Called my Doctor the day after receiving the shot and made an appointmen...
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I hadn't been feeling well. Called my Doctor the day after receiving the shot and made an appointment for the first available time (Friday April 2). On Thursday morning I was having vision problems, high blood pressure, weakness on left side. I was rushed to the hospital administered tPA and was diagnosed with a stroke.
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| 58 | 2021-04-11 | difficulty speaking | dizziness and throat was hoarse, monitored in the EMS room and discharged in stable condition |
| 58 | 2021-04-11 | numbness |
Left arm went numb from site of injection down to hand. It has not improved since onset. Tylenol an...
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Left arm went numb from site of injection down to hand. It has not improved since onset. Tylenol and ice treatment has been tried
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| 58 | 2021-04-12 | muscle spasms |
Day 2 Extreme fatigue and foggy head. I had to leave work as I was extremely tired and just driving ...
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Day 2 Extreme fatigue and foggy head. I had to leave work as I was extremely tired and just driving home was as if I was under the influence. Day 3 - Extreme fatigue and sever body aches Day 4 - Slightly better, but still not able to resume normal activities Day 5 - Tried to resume normal activities (bike ride), but I have to stop due to extreme fatigue and severe muscle cramping. Day 6 - Actually felt normal Day 7 - Back to 100%...
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| 58 | 2021-04-12 | pain in extremity |
58 year old white male with history of blood clots developed symptoms of leg pain during 4/11 early...
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58 year old white male with history of blood clots developed symptoms of leg pain during 4/11 early am . pt received COVID vaccine on 4/8 developed leg pain on 4/11 early am and went to er and was advised he was clotting in leg at point of previous procedure. he was given eliquis and was told to follow up with specialist
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| 58 | 2021-04-12 | pain in extremity |
Horrible pain all thru my body. The vaccine cause one hell of a Fibromalgia reaction. I can not ea...
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Horrible pain all thru my body. The vaccine cause one hell of a Fibromalgia reaction. I can not eat, I'm cold all the time. My apartment is 88 degrees and I'm still cold. I can't take this pain much longer. And my lungs are congested and burning. It's hard to breathe. HELP ! ! !
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| 58 | 2021-04-12 | tingling, numbness |
Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Tingling (specify: facial a...
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Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Tingling (specify: facial area, extremities)-Severe, Additional Details: tingling on the right side and front of face to the right temple had tingling, numbness, a bruised like feeling. PCP reviewed patients symptoms and stated everything was ok.
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| 58 | 2021-04-13 | involuntary muscle movements |
Very strong rash on the whole body. Muscular involuntary movements that still going on today, more ...
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Very strong rash on the whole body. Muscular involuntary movements that still going on today, more than 3 weeks after the shot.
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| 58 | 2021-04-13 | flushing |
Vomiting, dizziness, flushing/sweating. BP 134/82; HR 85, SpO2 98%, Temp 97.3. Pt reported feeling d...
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Vomiting, dizziness, flushing/sweating. BP 134/82; HR 85, SpO2 98%, Temp 97.3. Pt reported feeling dizzy while in observation. Pt was brought in to observation area. Pt felt dizzy, and nauseous began vomiting. Provider was called to assess pt; Pt reported feeling slightly better but still felt dizzy.
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| 58 | 2021-04-13 | tremor |
Patient received pfizer vaccine, sitting for observation for 15min and observed by next patient, who...
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Patient received pfizer vaccine, sitting for observation for 15min and observed by next patient, who alerted pharmacist, that he passed out, dropped phone/papers, and shakes. Pharmacist about to administer epipen but he regained consciousness in seconds, alert and stated dizzy, drank water given to him. 911 called and paramedic came to check him. BP is low, he's brought out in strecher to hospital(?) for evaluation. Wife came to pharmacy later to inquire since she got call from him being in hospital for observation. Wife stated that he is nervous about needles, vaccination
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| 58 | 2021-04-14 | difficulty speaking |
Anaphylaxis x- scratchy throat at +10 mins x- swollen tonsils at +15 mins x- difficulty swallowing a...
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Anaphylaxis x- scratchy throat at +10 mins x- swollen tonsils at +15 mins x- difficulty swallowing at +20 mins x- voice changed noticably at +30 mins, subsequently lost x- Some heart palpitations and chest tension at +45 mins x- Angiodema of right eye +90 mins
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| 58 | 2021-04-15 | feeling cold, weakness |
Excruciating pain in ALL o my body. The vaccine has triggered a Fibromyalgia episode from hell. Ex...
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Excruciating pain in ALL o my body. The vaccine has triggered a Fibromyalgia episode from hell. Extreme pain in ALL of my body. It feels like all my nerve endings are on fire. And when they are not on fire, they itch so bad, and I have scratched them so much, I have sores and scabs on my arms and legs from scratching a itch I can not reach. Feels like the itching is under my skin. Not on top. 1) Pain in ALL my body 2) High temperature - my house is 91 degrees and I'm in a blanket and I"m still cold 3) Even though I'm cold - I sweat a lot 4) Have not been able to eat since I got the vaccine 8 days ago - growing very weak and loosing weight 5) I'm dehydrated - Having trouble keeping liquids down 6) Bad stomach pains - sharp pains 7) Real bad gas and lots of it - Not normal for me 8) My kidneys hurt real bad - Probably clogged and overworked I spend most of my time on the floor n my back. Hurts too much to stand and walk NOTE: I'm growing weak and very dehydrated. Something needs to be done soon !
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| 58 | 2021-04-15 | numbness, tingling, burning sensation |
Severe numbness in my right arm and tingling like it?s asleep, then sometimes releases and burns the...
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Severe numbness in my right arm and tingling like it?s asleep, then sometimes releases and burns then goes back to tingling
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| 58 | 2021-04-17 | bell's palsy |
Developed Bells Palsy; This is a spontaneous report received a contactable consumer, the patient. A ...
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Developed Bells Palsy; This is a spontaneous report received a contactable consumer, the patient. A 58-year-old adult male received the first dose of BNT162b2 (solution for injection; Lot provided as unknown and expiry information not reported) as a single dose via unspecified route in the left arm on 25Mar2021 at 13:00 (at 58-years-old), for COVID-19 immunisation. Relevant medical history allergies to [unspecified] medications, food and/or other products. Concomitant medications included tetanus vaccine (lot unknown) dose 1 in right arm on 12Mar2021. The patient denied any COVID diagnosis prior to the vaccine. The patient reported that on 27Mar2021 at 12:00 he developed Bell's palsy; which was classified non-serious by the reporter. The patient has not been tested for COVID since the vaccine. Treatment for the event included prednisone regimen. The outcome of the event Bell's palsy was recovering. Information on the lot/batch number has been requested.
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| 58 | 2021-04-17 | nerve pain |
I had to be taken via ambulance to the E/R Hospital, . - After 10 days of excruciating pain, I had...
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I had to be taken via ambulance to the E/R Hospital, . - After 10 days of excruciating pain, I had to be taken to the E/R. I had not been able to keep down food in 10 days and for 3 days could not keep down liquids, so I went to the E/R. Pulse was down to 37bpm. Blood had a high clotting factor as was starting to clot. Every nerve in my body felt like it was being electrified while on Fire at the same time! Acute pain in my heart - Thought I was having a heart attack. High fever with chills and sweats. Extreme dehydration. And my kidneys hurt like hell. They are taxed working overtime. I was in such extreme pain, they had to shoot me up with Morphine every 4 hours to get it under control. They had to administer blood thinners to prevent clots. I'm still on blood thinners thanks to this damn vaccine! I was so dehydrated, they gave me 5 bags of IV Saline, a picture of Ice, a picture of Water, then a picture of Tea, before I could even urinate. I got to the E/R just in time before my heart stopped, or before a clot formed and killed me. Was in the hospital for 2 days. I'm home now, but still in pain. I can't eat but force myself to drink liquids. I do know if I will be getting any more vaccines...
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| 58 | 2021-04-17 | pain in extremity |
I got the shot and came home ever thing was fine then arm started hurting no big deal then thr heada...
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I got the shot and came home ever thing was fine then arm started hurting no big deal then thr headache so bad I had tears in 58. Carpet installer most of my life now that all happened Tuesday felt si; I got the shot and came home ever thing was fine then arm started hurting no big deal then thr headache so bad I had tears in 58. Carpet installer most of my life now that all happened Tuesday felt si; Tuesday felt sick; itching; Crazy itchy once I itch it swells up; I'm broke out all over my arm. And face; This is a spontaneous report from a contactable consumer or other non hcp. A 58-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number was not reported) via an unspecified route of administration, at arm left on 22Mar2021 12:00 as single dose for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. Medical history included high blood pressure. The patient had no allergies to medications, food, or other products. The patient received antibiotics within 2 weeks of vaccination. The patient concomitant medications were not reported. The patient got the shot and came home ever thing was fine then arm started hurting no big deal then the headache so bad I had tears. Carpet installer most of my life now that all happened Tuesday felt sick, we and things seemed instill till about the 26th started itching bad and it got worse and broke out all over my arm and face. Crazy itchy once I itch it swells up. The outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 58 | 2021-04-19 | weakness |
Day after first vaccine (Tuesday March 30) was administered, developed severe headache, chills, neck...
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Day after first vaccine (Tuesday March 30) was administered, developed severe headache, chills, neck pain, and slight abdominal cramp. By Friday April 2, severe abdominal cramp, headaches, nausea, slight high temperature. Persisted throughout the whole weekend. Called in sick Tuesday April 6 for abdominal cramp, temperature, confusion - admitted to ER.
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| 58 | 2021-04-19 | pain in extremity | Stiffness in injection site, next day, mild pain when lifting arm and mild cold symptoms. |
| 58 | 2021-04-20 | weakness |
Patient received the Pfizer shot at a vaccination clinic set up at his workplace. He was shockingl...
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Patient received the Pfizer shot at a vaccination clinic set up at his workplace. He was shockingly gray and visibly weakened for two and a half days. Patient gradually regained his strength. No other reaction was observed or mentioned.
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| 58 | 2021-04-20 | facial paralysis, tingling, numbness |
Patient presented to ED with complaint of right sided facial droop accompanied by numbness and tingl...
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Patient presented to ED with complaint of right sided facial droop accompanied by numbness and tingling. The patient went to bed at 0700 after working third shift with no symptoms and awoke at 1400 with these complaints. Patient was hypertensive at ED presentation. Patient was diagnosed with stroke and admitted to the hospital. Patient received clopidogrel (loaded with aspirin per self at home PTA).
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| 58 | 2021-04-22 | bell's palsy | LEFT FACIAL NERVE PALSY |
| 58 | 2021-04-22 | feeling cold, cold extremities |
Pfizer-BioNTech COVID-19 Vaccine EUA Cold sensation in the right arm, from the shoulder to the hand....
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Pfizer-BioNTech COVID-19 Vaccine EUA Cold sensation in the right arm, from the shoulder to the hand. Concern that this might be related to a blood vessel disorder with clotting problems
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| 58 | 2021-04-22 | seizure |
Ten minutes after receiving his second Covid-19 vaccine, patient became lightheaded. As I was moving...
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Ten minutes after receiving his second Covid-19 vaccine, patient became lightheaded. As I was moving him to the ground, he started to have what appeared to be a seizure. I got him on his side to the ground and he proceeded to vomit twice, about 2 minutes apart. 911 was called and patient was transported by ambulance to the emergency room for follow up.
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| 58 | 2021-04-23 | weakness, tingling |
Intense tingling on palms and bottom; chills; weakness; stomach pain; chest pain; low grade fever; n...
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Intense tingling on palms and bottom; chills; weakness; stomach pain; chest pain; low grade fever; needed bed rest; This is a spontaneous report from a contactable consumer (Patient). A 58-years-old male patient received first dose of BNT162B2 (BNT162B2), Via an unspecified route of administration, administered in Arm Right on 09Jan2021 08:30 (Batch/Lot Number: EK9231) as single, dose 2 via an unspecified route of administration, administered in Arm Right on 30Jan2021 (Batch/Lot Number: EL9262) as single for covid-19 immunisation. The patient Medical history included glaucoma, asthma, hypersensitivity from an unknown date and unknown if ongoing. The patient's concomitant medications included simvastatin (SIMVASTATIN); atropine (ATROPINE); dorzolamide (DORZOLAMIDE); escitalopram oxalate (LATA) taken for an unspecified indication, start and stop date were not reported. The patient experienced intense tingling on palms and bottom (paraesthesia), chills (chills), weakness (asthenia), stomach pain (abdominal pain upper), chest pain (chest pain), low grade fever (pyrexia), needed bed rest (bed rest) on 09Feb2021. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 11Feb2021. Therapeutic measures were taken as a result of intense tingling on palms and bottom (paraesthesia), chills (chills), weakness (asthenia), stomach pain (abdominal pain upper), chest pain (chest pain), low grade fever (pyrexia), needed bed rest (bed rest). The outcome of events was recovering.
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| 58 | 2021-04-23 | tingling |
mild tingling sensation on the back part of my tongue; metal taste; This is a spontaneous report fro...
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mild tingling sensation on the back part of my tongue; metal taste; This is a spontaneous report from a contactable consumer (patient). A 58-year-old male received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: EL9264), via an unspecified route of administration, in the left arm on 29Jan2021 at 09:30 (at the age of 58-years-old) as a single dose for covid-19 immunisation. Patient's medical history included cardiovascular disease, 2 stents and hypertension (on medications). The patient was not aware of any allergies to medications, food or other products. Patient did not receive any other vaccines within 4 weeks prior to vaccination. Concomitant medications included (acetylsalicylic acid) LD ASPIRIN, metoprolol succinate (TOPROL), clopidogrel bisulfate (PLAVIX), valsartan (DIOVAN), atorvastatin (LIPITOR) and ergocalciferol (VIT D). Prior to the vaccination the patient was not diagnosed with COVID-19. On 29Jan2021 at 09:30, the patient experienced mild tingling sensation on the back part of my tongue and metal taste. Sensation peaked at approx. 30-40 minutes then started to subside. Fully subsided after approx. 2 hours. Treatment was received. Patient underwent Blood pressure measurement, pulse rate and oxygen saturation on 29Jan2021 and results were unknown. Since the vaccination the patient had not been tested for COVID-19. The outcome of the event paraesthesia was recovered on 29Jan2021 at 11:30 and Dysgeusia was recovered on an unspecified date in 2021.
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| 58 | 2021-04-24 | muscle spasms, nerve pain |
Felt like all my nerve endings were being electrified while on Fire; I could not keep down food for ...
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Felt like all my nerve endings were being electrified while on Fire; I could not keep down food for 10 days. Then, could not keep down liquids for 3 days then went to the E/R; High Clotting Factor; dehydration; chest pains/Had pains in my heart also; Heart was not beating correctly; body cramps all over; High temperature along with sudden chills; High temperature along with sudden chills; frequent sweats; Extreme pain; This is a spontaneous report from a contactable consumer (Patient, self-reported). A 58-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and expiration dates were not reported), via an unspecified route of administration in left arm on 06Apr2021 at 07:00 PM, at single dose for COVID-19 immunisation. The patient had medical history of fibromyalgi, anxiety and allergy to all anti-depressants. The concomitant medication included clonidine once a day for anxiety. It reported that, on 07Apr2021 at 8:00 AM, patient experienced extreme pain felt like all nerve endings were being electrified while on fire such extreme pain ever since the vaccine. After 10 days he could not take it anymore. Patient could not keep down food for 10 days. Then, could not keep down liquids for 3 days then went to the E/R. Had a high clotting factor along with dehydration and chest pains. Heart was not beating correctly, and they were worried his blood would clot, heart attack, aneurism and death. He had pains in heart also, body cramps all over. High temperature along with sudden chills and frequent sweat. Contact the ICU ward at for all the details on the problem vaccine caused. The all adverse event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event), disability or permanent damage. Patient hospitalized for the 2 days and treated with the morphine for pain, 5 bags of Saline and blood Thinner. Vaccination facility: Pharmacy or Drug Store. Patient did not take any other vaccine in four weeks. There was no COVID prior vaccination and COVID tested post vaccination (Nasal Swab, result negative) on 16Apr2021. Information about lot/batch number has been requested.
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| 58 | 2021-04-24 | pain in extremity |
extreme arm pain; shoulder pain; arm and shoulder pain/it was not really a soreness, it was an injur...
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extreme arm pain; shoulder pain; arm and shoulder pain/it was not really a soreness, it was an injury; This is a spontaneous report from a contactable consumer (patient). This 58-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in left shoulder or arm on 16Mar2021 15:00 (Lot Number: EN6200; Expiration Date: 30Jun2021) at single dose for COVID-19 immunization. Medical history included sports injuries. Patient said he has had sports injuries, when he used to play tennis, but nothing on his left side. The patient's concomitant medication was none. Patient said they have not had any other recent vaccinations or started any new medications. He said there was a new med he thought he started before getting the first vaccine, it said March 30th, so it had to be in February that he started this, this was date for second dose, so he didn't think that there was anything close to second vaccine dose. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at age of 58-year-old, administration on 23Feb2021 4:00 PM in left shoulder or arm (Lot number: EN6200, Expiration date: 30Jun2021) for COVID-19 Immunization. Patient has had vaccines all his life with no problems. He has had extreme arm pain mostly to his shoulder into his arm after he took the second shot dose roughly three weeks ago. He said that his arm and shoulder pain began 17Mar2021, and had lasted to today. He said it was not really a soreness, it was an injury. He said it had gotten a little worse the last couple of days. He said he stopped taking Aleve since you are not supposed to take that long because of bleeding problems. He was taking 4 a day for a week then stopped taking it. He said he was taking two in the morning and two at night, strength unknown. He said his pain was almost getting better, but it seemed worse since he stopped taking the Aleve. He said the pain affect what he normally did like tennis and yard work, it woke him in the middle of the night with pain, he was right handed. He said he also tried Bengay and things that didn't seem to work. The outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.
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| 58 | 2021-04-24 | pain in extremity |
Four hours later he passed out/ Four hours after getting vaccine he was on the floor and out like a ...
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Four hours later he passed out/ Four hours after getting vaccine he was on the floor and out like a light; Sore right arm; goofy; This is a spontaneous report from a contactable consumer. A 58-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose at the age of 58-years-old intramuscular, administered in Arm Right on 04Mar2021 09:30 (Batch/Lot Number: EN6200) as single dose for covid-19 immunisation and prophylaxis. Medical history included high cholesterol, allergy (When pollen is heavy, it is worse) from an unknown date and unknown if ongoing, fractured his shoulder in 05Feb2021, sinus jacked up from an unknown date and unknown if ongoing, covid-19 from Nov2020 to an unknown date, anemic from Dec2020 to an unknown date, nasal surgery on an unknown date, fever blisters from an unknown date and unknown if ongoing, immune system disorder from an unknown date and unknown if ongoing. Concomitant medications included zolpidem tartrate (AMBIEN) taken to help sleep; atorvastatin (LIPITOR) taken for high cholesterol; loratadine taken for allergy; cetirizine hydrochloride (ZYRTEC) taken for allergy; mometasone furoate (FLONASE) taken for allergy; start and stop date were not reported for all; fish oil (OMEGA 3) and selenium (SELENIUM) taken for an unspecified indication, start and stop date were not reported; colecalciferol (VITAMIN D3 1000) taken for immune system disorder; iron (IRON) taken for anaemia; lysine taken for fever blisters ; zinc taken for immune system disorder, start and stop date were not reported for all and multivitamin. It was reported that four hours after getting vaccine on 04Mar2021, he was on the floor and out like a light. This is the first one he received and his doctor said not to get second one. He had the first one and about 4 hours later, he was on the kitchen floor and out like a light. He doesn't know if it was connected to shot or not. He never had problems before. He got the vaccine around 09:30 and around 13:30, his friend came in for lunch and found him on the floor. She freaked out. She said she liked to never got him awake and said he was goofy for a good half hour. He does not know how long he was on the floor. His arm was sore on 04Mar2021 09:30 for about 4 days. The patient underwent lab tests and procedures which included blood iron: so low on an unspecified date. The patient was recovering from passed out and sore arm while recovered from goofy on 04Mar2021.
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| 58 | 2021-04-24 | tingling, burning sensation, nerve pain |
I was vaccinated at the pharmacy with the Pfizer Covid-19 vaccine on 4/6/2021. I woke on 4/7/2021 w...
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I was vaccinated at the pharmacy with the Pfizer Covid-19 vaccine on 4/6/2021. I woke on 4/7/2021 with every nerve in my body on fire! It's been that way ever since. . . I have real bad Fibromyalgia for over 25 years, and has been under control for 18 months now, requiring no medication / pain killers, until I received the Pfizer vaccine... 4/6/2021 7:00pm Received 1st Pfizer Covid-19 vaccine 4/7/2021 I awoke in excruciating pain. Every nerve in my body felt like I had been Electrocuted leaving a painful tingly sensation, while at the same time on Fire. The pain was so bad, I could not keep down food. After 7 days of no food and constant pain level of 7 - 9 (10 point scale) my body started rejected everything; No food or liquids at all! After 3 more days (10 days total) I was taken to the E/R. After several tests, they immediately put me on IV drip of Saline, IV drip of Potassium, blood thinners, and pain killers. The vaccine triggered a "High Clotting Factor" in my blood and the Dr.s were worried about blood clots / stroke. Morphine was administered to reduce my pain. After 2 days in the hospital, 5 bags of Saline, 2 bags of Potassium, Potassium supplements, Blood Thinners, a picture of Ice, a picture of Water, a picture of Tea, and morphine shots every 4 hours, I could finally urinate, but my Kidneys hurt like hell. They still do. SUMMARY: * It's been 19 days and I still can't keep down food * I'm still in excruciating pain ! ! ! (have appointment with Pain Management Dr. next week) * At least I'm able to keep down liquids now * Have lost 14lbs since the vaccine * I have been bedridden ever since receiving the vaccine, the pain is that bad * Kidneys still hurt like hell * Will this pain ever end ? ? ?
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| 58 | 2021-04-24 | seizure |
Full blown seizure; Fatigue; Confusion; Breathing was off; breath was heavier; patient's blood press...
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Full blown seizure; Fatigue; Confusion; Breathing was off; breath was heavier; patient's blood pressure was very low; Real sluggish/get slow; Speech started to get slow; This is spontaneous report from a contactable consumer (patient's wife). A 58-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8734) via an unspecified route of administration in left arm on 04Apr2021 12:00 at age of 58-year-old at single dose for COVID-19 immunization. It also stated the patient was one of the most vulnerable against virus so he took the Covid-19 Vaccine. Medical history included ongoing cardiac failure congestive diagnosed probably 10 years ago, ongoing diabetes mellitus diagnosed probably 20 years ago, ongoing dialysis for 3.5 years. Concomitant medication included ongoing unspecified blood thinner. Caller reported that the patient didn't take any blood pressure medications and that she knew the patient took a blood thinner. Caller unable to provide further detail for the patient's medications as she doesn't have the patient's list of medications with her. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EP7534) injected in left arm in Mar2021 at age of 58-year-old for COVID-19 immunization and experienced fatigue after the first dose of the Covid-19 vaccine. Caller reported that it was hard to determine the cause of the fatigue because the patient was on dialysis, but that the patient has been more fatigued since he received the first dose of the Covid-19 vaccine. The patient was a compromised fellow with a host of pre-existing conditions as far as heart disease, diabetes, and dialysis. Caller was calling in regard to the Pfizer Covid-19 vaccine. Caller reported that she was calling to report a bad reaction that her husband, the patient, received on Sunday, 04Apr2021, following his second dose of the Covid-19 vaccine. Approximately 3 hours after receiving the Covid-19 vaccine, the patient had a full blown seizure at 15:00 on Sunday, 04Apr2021. Caller reported that she had to call emergency responders following the patient's seizure. The patient was doing better but the experience with his seizure was quite traumatic. Caller stated that if it was going to happen, it was going to happen to us. About 3 hours after receiving his Covid-19 vaccine on 04Apr2021, the patient became real sluggish and his speech started getting slow before the seizure occurred. Caller reported that the patient made a gradual descent downwards. Caller reported that she swears the patient has not been the same as far as fatigue goes since the patient received his first dose of the Covid-19 vaccine 3 weeks prior. Caller reported that she thought the fatigue was maybe from dialysis. The patient started to get slow just before the seizure, about 2.5 hours after he received the second dose of the Covid-19 vaccine. The patient was laying down following the second dose of the Covid-19 vaccine. Caller reported that the patient's breathing was off. The patient's breath was heavier. Caller reported that after she noticed the patient's breathing was off, she asked the patient if he was ok. Caller reported that this is when she noticed that the patient's speech was really slow and that he was experiencing confusion. The patient has had no more seizure activity. The patient was still being monitored in the hospital. Caller reported that the patient didn't remember any of it. It's hard to say if the patient's sluggishness and fatigue were ongoing. Caller reported that she couldn't go see the patient while he was in the hospital but that the patient's voice sounds much stronger. For Confusion and Speech: Caller reported that the patient seems to be back/ returned to normal. Caller reported that she knew that the patient's cardiologist went to see the patient. The patient's cardiologist said that there was nothing that happened to the patient's heart, that what the patient experienced was not a heart issue, and that the event had no effect on the patient's heart. The medical staff stated that the seizure the patient experienced was related to a blood pressure drop. Caller reported that the patient's blood pressure was very low on 04Apr2021. The patient required a visit to Emergency Room for event seizure, no visit of physician office. Admitted on Sunday, 04Apr2021 for seizure, and still hospitalized. For investigations: Caller reported that the medical staff at the hospital definitely did lab work but she was not sure if any imaging was performed. Caller reported that she has no results available for tests that were performed. The outcome of events confusion and "speech started to get slow" was recovered in Apr2021, the outcome of other events was unknown. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021380129 same patient, different product(dose)/event
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| 58 | 2021-04-26 | bell's palsy |
Bells Palsy; This is a spontaneous report from a contactable consumer reporting for husband. A 58-ye...
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Bells Palsy; This is a spontaneous report from a contactable consumer reporting for husband. A 58-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EW0153/expiration date: 31Jul2021), via an unspecified route of administration, on 11Apr2021 (at the age of 58 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. The patient previously patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EM8727/expiration date: 31Jul2021), via an unspecified route of administration, on 21Mar2021 (at the age of 58 years old) as a single dose for COVID-19 IMMUNIZATION. Relevant medical history included ongoing hypertension, when he was about 45, probably 10 years and was recovering from leukemia onset 2 years ago, in 2019 and he has been recovering from leukemia since about 2020; the patient had an ongoing history of being a little overweight, with onset unknown other than over 10 years ago. Concomitant medication included nebivolol hydrochloride (BYSTOLIC) 10mg tablet taken by mouth once daily for hypertension. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Apr2021, late afternoon the patient experienced swelling in his face, couldn't blink, drooping and was diagnosed with Bells Palsy which required an emergency room visit. He was not admitted to the hospital for this event, was kept under observation only in the emergency room on 12Apr2021. He was given some medication and then discharged. Bell's Palsy affected his right side of his face. The outcome was improved, the pain was a little less; but he still does not have, nothing works on the right side of his face. His right eye does not blink, eyebrow does not move, and he still can't speak very good. Treatment was received for the event. The outcome of the events Bells Palsy was recovering. Since the vaccination, the patient had not been tested for COVID-19.
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| 58 | 2021-04-26 | nerve pain, tingling |
I was vaccinated at pharmacy with the Pfizer Covid-19 vaccine on 4/6/2021. I woke on 4/7/2021 with ...
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I was vaccinated at pharmacy with the Pfizer Covid-19 vaccine on 4/6/2021. I woke on 4/7/2021 with every nerve in my body on fire! It's been that way ever since. . . I have real bad Fibromyalgia for over 25 years, and has been under control for 18 months now, requiring no medication / pain killers, until I received the Pfizer vaccine... 4/6/2021 7:00pm Received 1st Pfizer Covid-19 vaccine 4/7/2021 I awoke in excruciating pain. Every nerve in my body felt like I had been Electrocuted leaving a painful tingly sensation, while at the same time on FIRE! The pain was so bad, I could not keep down food. After 7 days of no food and constant pain level of 7 - 9 (10 point scale) my body started rejected everything; No food or liquids at all! After 3 more days (10 days total) I was taken to the E/R at Hospital. After several tests, they immediately put me on IV drip of Saline, IV drip of Potassium, blood thinners, and pain killers. The vaccine triggered a "High Clotting Factor" in my blood and the Dr.s were worried about blood clots / stroke. Dr. say if I would have waited any longer, I would have developed a blood clot and have a possible stroke. My heart rate was only 37bpm.! They were worried my body / brain was not getting enough oxygen. Morphine was administered every 4 hours to reduce my pain. After 2 days in the hospital, 5 bags of Saline, 2 bags of Potassium, Potassium supplements, Blood Thinners, a picture of Ice, a picture of Water, a picture of Tea, and morphine shots every 4 hours, I could finally urinate, but my Kidneys hurt like hell. They still do. SUMMARY: * It's been 21 days and I still can't keep down food * I'm still in excruciating pain ! ! ! (Dr. has me on mild pain killers, but they are not enough...) * At least I'm able to keep down liquids now * Have lost 21lbs since the vaccine - Loosing an average of 1lb a day * I have been bedridden ever since receiving the vaccine, the pain is that bad * Kidneys still hurt like hell * Will this pain ever end ? ? ?
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| 58 | 2021-04-26 | seizure | At about 1030 patient had a seizure.. |
| 58 | 2021-04-26 | tremor, muscle spasms |
Acute onset severe muscle spasming of right semitendinosis muscles and daily muscle tremors of same ...
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Acute onset severe muscle spasming of right semitendinosis muscles and daily muscle tremors of same muscles to date.
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| 58 | 2021-04-27 | numbness |
The patient noticed itchiness and a rash that spread up his arm over his collar bone. He said that t...
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The patient noticed itchiness and a rash that spread up his arm over his collar bone. He said that the area was very read and on about day 5 the area of the rash went numb.
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| 58 | 2021-04-28 | weakness, paralysis |
On or about April 14, 2021 patient yelled out to a friend to come help him. Patient stated that he "...
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On or about April 14, 2021 patient yelled out to a friend to come help him. Patient stated that he "could not see or move". The friend called the ambulance and patient was taken to hospital. One of the doctors tending to patient told me patient had several strokes (over 5). These strokes have left him blind and incapacitated. He is still currently at hospital.
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| 58 | 2021-04-28 | facial paralysis, numbness, slurring |
Suspected TIA; Experienced a numbness in right hand, arm, drooping right side of face; Experienced a...
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Suspected TIA; Experienced a numbness in right hand, arm, drooping right side of face; Experienced a numbness in right hand, arm, drooping right side of face; slurred speech; This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), first dose in right arm on 05Mar2021 14:30 (Lot: EN6199) and second dose in left arm on 26Mar2021 14:30 (Lot: ER8732); both via an unspecified route of administration (at the age of 58-years-old) as single dose for covid-19 immunisation. The vaccination facility type was a public health department. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to bnt162b2. Medical history included allergy induced asthma and seasonal allergies. The patient's concomitant medications were not reported. The patient experienced a numbness in right hand, arm, drooping right side of face and slurred speech, it lasted for 1-2 minutes. The patient went to the ER. Suspected TIA. These events started on 11Apr2021 at 10:00. The events resulted in emergency room/department or urgent care. The patient received unspecified treatment for the events. On 10Apr2021, nasal swab was negative. On 11Apr2021, Covid test type post vaccination with unknown results, rapid and nasal swab was negative. It was reported that the patient had MRI, CT, EKG with unknown results on unspecified dates. The outcome of the events was recovering.
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| 58 | 2021-04-30 | seizure |
Low fever beginning on 1:00AM Monday 12Apr; Experienced nausea Monday 12Apr evening and seizure; Exp...
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Low fever beginning on 1:00AM Monday 12Apr; Experienced nausea Monday 12Apr evening and seizure; Experienced nausea Monday 12Apr evening and seizure; This is a spontaneous report from a contactable consumer. A 58-year-old male patient received first dose of BNT162B2 (BNT162B2) via an unspecified route of administration on 07Apr2021 (Batch/Lot Number: ENG201) as SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced nausea monday 12Apr evening and seizure and low fever beginning on 1:00am monday 12apr at 01:00. The patient was hospitalized for experienced nausea monday 12apr evening and seizure and for low fever beginning on 1:00am monday 12apr for 4 days. Therapeutic measures were taken as a result of low fever beginning on 1:00am monday 12apr. It was unknown if therapeutic measures were taken for the events Experienced nausea Monday 12Apr evening and seizure. The outcome of the events was unknown.
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| 58 | 2021-05-02 | discomfort, weakness |
PERNICIOUS PALPITATIONS (RACING HEARTBEAT, 130/MIN?), ABOUT 5 EPISODES IN 5 HOURS. THE SECOND EPISOD...
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PERNICIOUS PALPITATIONS (RACING HEARTBEAT, 130/MIN?), ABOUT 5 EPISODES IN 5 HOURS. THE SECOND EPISODE WAS THE WORST. ELEVATED BLOOD PRESSURE (180/110?) DURING PALPITATIONS. OVERALL DISCOMFORT IN WHOLE BODY. STAYED IN EMERGENCY ROOM FOR ABOUT 5+ HOURS. EVEN AFTER DISCHARGE, MUCH MILDER EPISODES LASTED THROUGHOUT THE NIGHT. EMERGENCY ROOM TREATMENT WAS ONLY SALINE. PATIENT TOOK 160 MG MAGNESIUM AFTER SECOND EPISODE. AT HOME PATIENT TOOK SOME MORE MAGNESIUM (~50 MG) AND VERAPAMIL (~60MG). 30 HOURS AFTER THE INCIDENT, MOSTLY RECOVERED BUT FEELING WEAK.
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| 58 | 2021-05-02 | unresponsive to stimuli |
On 4/14/2021 pts sugar dropped to 40. EMT was called. They gave him some meds to bring it back up....
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On 4/14/2021 pts sugar dropped to 40. EMT was called. They gave him some meds to bring it back up. He was still not feeling well that night he took some more sugar meds and went to bed. Next morning he was foaming at the mouth and unresponsive. EMT was called again. On 4/15/2021 Pt was taken to the ER. He was intubated and transferred to another ER. He has a trach, has a feeding tube and has swelling of the brain.
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| 58 | 2021-05-04 | burning sensation, pain in extremity |
Immediately following the injection, my right shoulder, elbow, forearm and wrist started to get sore...
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Immediately following the injection, my right shoulder, elbow, forearm and wrist started to get sore. Each day thereafter my shoulder was really sore, I am having these burning sensations in my right forearm and my wrist is in pain. It has been 5 days since my second vaccine and each day has been very rough to get through. I have 2 jobs and the pain is interfering with my job duties. And when I'm trying to sleep, it's very uncomfortable and I haven't been able to get a full night's rest. I haven't seen any doctors or taken any medication because I thought that the symptoms would go away but they haven't. I don't know what to do
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| 58 | 2021-05-04 | tingling, numbness |
Onset of moderate to severe dizziness, immediately followed by tingling sensation, then severe numbn...
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Onset of moderate to severe dizziness, immediately followed by tingling sensation, then severe numbness on entire left side of face (left lips) and entire outside left side body, from head to toes. Face, neck shoulder, arm, torso, leg, foot and toes
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| 58 | 2021-05-07 | pain in extremity |
I don't know it is stroke or something; heart burn something; its like I am having a heart attack; f...
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I don't know it is stroke or something; heart burn something; its like I am having a heart attack; feeling crappy/ feeling funny/ I can feel like the drug was inside me like something was changing/ something happening with my body; Headache/ slight headache; Chest pain/ I can feel a pain where my heart is; arm was sore; heart burn; This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on the left arm on 09Apr2021 at a single dose for COVID-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient previously received first dose of BNT162B2 on 18Mar2021 for COVID-19 immunisation (left arm). Patient stated, "the second was really bad my arm was sore for like over a week I mean it was sore. I don't know I have not felt the same since. I can feel like the drug was inside me like something was changing and I never had no problem for anything but now its been like at the last when I got the shot was 9th of April of this month, its been like 2 weeks now almost and it is like I feel crappy. I have headache I have like a chest pain u know in my chest. I have like my heart is I don't know its like I am having a heart attack or something I don't know it is stroke or something. I do not know it is feeling funny. I have no problem I do, may be I have may be heart burn something. I don't know because on every single day everyday I have chest pain my heart, headache I have slight headache now. I don't know why I can feel a pain where my heart is on left side now I got the pain on right side you know I have the pain there and I wondering what's going on so I don't know". Consumer stated, "First its both side that is what I am saying now right now so as I am talking to I have pain in my heart and like it feels the heart u know I don't know there is a weird thing in my heart. I feel like you have a heart attack or so, I you feel like a chest pain or you had a heart burn or something and then on my right side has started it is like something happening with my body you know now its the right side. I don't really know, I can feel me liver, my kidneys are like something is like I can feel something is going I don't know what's going on with my body. You know after getting the shot right now I have the slight headache. I took a quite couple of Tylenol as stuff but that seems like no. This every single day you know that you I thought it will go away but it did not go away". Consumer stated, "Yes, it is the first time. Like I said I thought it will go away but it is not getting any better. I am getting concerned. I do not know I have to be admitted to hospital. I do not have no insurance or anything. I am really worried." The patient hasn't been to the doctor, he was calling first for help. He has no insurance so he cannot just go to the doctor. Consumer stated, "It never improved no. Persisting." Outcome of the events was not recovered. Information on the lot/batch number has been requested.
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| 58 | 2021-05-12 | pain in extremity |
Patient has had pain and decreased ROM in his arm since the second vaccine that he has received. To ...
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Patient has had pain and decreased ROM in his arm since the second vaccine that he has received. To the point that he is dealing with PT. Patient is a surgeon, so the impaired mobility is quite an issue.
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| 58 | 2021-05-17 | feeling cold, seizure |
foaming from the mouth/foaming at the mouth; blood sugar dropping; He would not wake up and was unre...
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foaming from the mouth/foaming at the mouth; blood sugar dropping; He would not wake up and was unresponsive; seizures; swelling on brain; Pneumonia aspirating; so cold he could not work or anything; This is a spontaneous report from a contactable consumer reporting on behalf of her fiance. A 58-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 08Jan2021 (Batch/Lot Number: EL3248) as SINGLE DOSE for covid-19 immunization at the age of 58 years old. Medical history included sugar /diabetic, blood pressure. None vaccines administered on same date with the Pfizer vaccine considered as suspect. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine. Family Medical History Relevant to AEs was none. Concomitant medication(s) included metformin hcl for Diabetes, he has been on for a long time; pregabalin for his back and leg because he had 2 pinched nerves or something and he has to get it repaired with injections. He has not gotten injections because of what he has been going through right now. It is 25 mg and he has been on this for a little while; lisinopril for cholesterol and is a blood pressure and heart pill; vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]) for his vitamin D was low; diclofenac sodium (DICLOFENAC NA) for inflammation, he has been on this for as long as she knows; potassium chloride (POTASSIUM [POTASSIUM CHLORIDE]) for his potassium is low, She has been giving this to him. Whenever he gets blood work, sometimes they say his potassium is low so she gives it to him everyday; amlodipine besylate for blood pressure and heart; sertraline hcl for a mood pill, he has been on a long time; Metoprolol succinate for blood pressure and heart, He has been on for a long time. The patient previously received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 28Dec2020 (Batch/Lot Number: EJ1682) as SINGLE DOSE for covid-19 immunisation. The patient experienced foaming from the mouth/foaming at the mouth, blood sugar dropping, he would not wake up and was unresponsive, seizures, swelling on brain, pneumonia aspirating, so cold he could not work or anything in Apr2021. Reported as: He had the Pfizer shot, but he is currently hospitalized, he had an experience of foaming from the mouth, 3 months after the vaccine. He is on a trach/ requires trach and feeding tube. He is also on dialysis to clean the toxins in his blood. Caller stateed she is calling on behalf of her fiance. He can not talk to anyone at the moment. The reason she is calling is because he had his vaccine 08Jan2021. Caller states but the thing is that nobody knows what symptoms anybody is going to have. It has been what, 3 months, but his sugar dropped to 40 one day, and 30 one day. He was foaming at the mouth and had seizures. Aspirated, pneumonia: caller states that her fiance aspirated and had pneumonia in his right lung and has been in the hospital ever since. Foaming at the mouth: He is on a trach and feeding tube, dialysis in his neck, and caller is trying to figure out what is going on. Caller adds that he was foaming at the mouth. Blood sugar dropping, so cold he could not work or anything: caller states this happened Tuesday 2 weeks ago. She has been working and going there to see him. This is the first time she has trying to think and get answers herself. Caller adds that she tested his blood sugar and must have touched it with her own finger because it said 197. The paramedic said no it was 40. Caller states the paramedic gave her fiance IV stuff that shot it up and brought it up to 290, which was good. They wanted him to eat peanut butter and jelly and he said no and fought with them. The sugar was still not going up, and sugar was out of sorts. He took a few bites and it was okay. He asked for soup because he was so cold he could not work or anything. Caller becomes tearful and adds that her fiance's mom passed 6 months ago and they were talking. He got 20 units of lantus, normally he takes 50. They went to bed and caller adds she guesses because her nerves were shot or something she called off of work that night. She got up to go to the bathroom and let the dogs out and went to check on him. She did not have the light on and when she turned the light on she saw her fiance foaming at the mouth. He would not wake up and was unresponsive. Paramedics came and gave him a shot and IV to put sugar back in. They asked which hospital she would like him to go to and they said they could not take him to that hospital so they took him to another place. Seizures: They then put a breathing tube into him. The doctor said she was sorry but she knocked the man's tooth out. Then, they had to switch him to the mother hospital because they had to put probes on his head to monitor his seizures because he had seizures. He had swelling on the brain, pneumonia, and was aspirating. Caller adds she is not sure if she touched the strip with her finger and that was the false reason, and his blood sugar was only 40. caller confirmed that the blood sugar increased to 290 following the paramedics giving her fiance sugar. Caller adds she does not know how to work that stupid thing. He never showed her how to do it. If he had showed her, she would know what to do. She said it said 197 but the paramedics told her it was 40. She has to learn how to do this. Patient requires trach, feeding tube, and dialysis: Caller was asked to clarify dates and she states that this was Wednesday, the next day. He has not foamed from the mouth since then, and they are not sure if he is doing seizures or not. They asked and the hospital said they are not sure because they do not have probes on him. Now, he is on a trach and feeding tube. They are also giving him some type of dialysis through his neck to get rid of toxins in the blood and filtering it back to him. Caller clarifies date of hospitalization as 15Apr2021 she would think, but she does not even know. Caller thinks it has been two or three weeks. First, he went to the place she mentioned and then he was transferred to the other and that is where he has been since. Indication: he worked up on 4 a lot which he is the maintenance where he works. They wanted him to get the Pfizer because not too many people wanted to go up there. He figured he would take it and with his blood pressure and sugar it would help. He was up there fixing things and stuff like that, or at least that is what she was told by someone else. Caller verifies that the low blood sugars, foaming at the mouth, and being unresponsive were what hospitalized the patient. She does not know dates, she thinks it was around 15Apr2021, and he is still in the hospital. Investigations: caller states that she knows he went back, she does not know when, and that since it is May now, he must have gone back a few months ago for lab work. It was in the morning, he went before work, and they did all kinds of stuff and to see where his A1C was. Caller adds that it was 11. Whatever else they are checking him for now she is not sure. Reporter details: caller states that she is a health care professional right no. She adds she is in housekeeping and in the health field and that she hears a lot of things, just because she does not say them. caller does not clarify statement regarding hearing a lot of things. Her head is going all sorts of ways. Caller adds she is batting her head against the wall. She is trying to put her head around everything happening. This is the only thing different. Everybody's body is different. No AEs required a visit to Physician office. but leading to Emergency Room, She states that it is the MIC Unit, and then clarifies as MICU. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.
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| 58 | 2021-05-18 | flushing |
Typically reported aches along with flushness of skin, especially both arms. Adverse condition was m...
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Typically reported aches along with flushness of skin, especially both arms. Adverse condition was mild blue and black bruising over 10 to 15% of both legs - calves and thighs. Majority of bruising faded over a 6 to 8 hour following its discovery.
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| 58 | 2021-05-25 | one side paralysis, numbness |
Patient received the vaccine on 3-31-21. Then at 4:00 am on 4-1-2021, he became lightheaded and rep...
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Patient received the vaccine on 3-31-21. Then at 4:00 am on 4-1-2021, he became lightheaded and reports passing out. He had several weeks of general malaise and mild headache. He does not recall head trauma and had no bruising, "goose egg", etc. He felt generally unwell with a mild headache since then. Then on May 16th, 2021, while traveling with his wife, his left hand and arm and left side of tongue became numb and week. He was mildly confused. His wife took him to the ER and he was transferred to hospital for neurosurgery admission. Hospital records note that they presume the subdural bleed was triggered from the fall the morning of May 5th.
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| 58 | 2021-05-26 | cold sweat |
Approx 5 min after receiving the 2nd Pfizer COVID vaccine the patient fainted hitting head against w...
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Approx 5 min after receiving the 2nd Pfizer COVID vaccine the patient fainted hitting head against wall, scraping knee from falling and biting his lip. Pt was unconscious for approx 45 secs to 1 min. Vitals remained within normal limits during entire encounter except for increase in respiration rate of about 26-28. After regaining consciousness the pt was confused, nauseas, vomiting, diaphoretic and clammy to the touch. EMS arrived un scene approx 5-10 minutes after pt hitting his head and was transported to Hospital
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| 58 | 2021-05-26 | discomfort |
Sudden sensorineural hearing loss on the right ear. Symptoms started 1 week after the 2nd dose of th...
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Sudden sensorineural hearing loss on the right ear. Symptoms started 1 week after the 2nd dose of the COVID-19 vaccine on Monday 5/17. The hearing loss was accompanied by continuous buzzing sound, static noise, sensation of ear fullness, local discomfort, headache. It progressed over the first week. On saturday 5/22, I performed an online hearing test that confirmed the hearing loss (see section 19 for results). I went to urgent care to get the ear checked and cleaned, with no noticeable improvement in symptoms. On Sunday 5/23 I was started on 30 mg predinsone po. On Monday 5/24, I went to specialist care, she increased dose to 60 mg of prednisone and order additional tests.
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| 58 | 2021-05-26 | feeling cold |
Patient received their 2nd Pfizer COVID vaccine and about 5 minutes afterwards in the observation ar...
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Patient received their 2nd Pfizer COVID vaccine and about 5 minutes afterwards in the observation area the patient became lightheaded and collapsed hitting his head against the wall, EMS was called. While collapsing the patient bit his tongue, scraped his knee, and developed a visible bump on his head. Patient was unconscious while collapsed lasting approximately 45 seconds to 1 minute. When he regained consciousness he was confused and unaware where he was or what happened. Vitals were taken throughout being unconscious every 5 minutes until EMS arrived which was about 5-10 minutes after the patient collapsed. After regaining consciousness patient was cold, diaphoretic, nauseas, and emesis x 2. Report was given to EMS and transported to Hospital.
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| 58 | 2021-05-30 | weakness, tremor |
Serious diarrhea, vertigo, headaches, nausea, shaky, weak Dicyclomine 20 mg 3x daily May 20-28th di...
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Serious diarrhea, vertigo, headaches, nausea, shaky, weak Dicyclomine 20 mg 3x daily May 20-28th did not help, still have diarrehea, vertigo, etc metroNidazole 500mg 2x daily - still have loose bowels, vertigo, etc
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| 58 | 2021-05-30 | numbness | Transverse myelitis with lower limb weakness and numbness. Treated with steroids and IVIG. |
| 58 | 2021-05-31 | feeling cold |
Saying he could not breath; anxious; reported being cold; complained of Chest pain; began to shake; ...
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Saying he could not breath; anxious; reported being cold; complained of Chest pain; began to shake; This is a spontaneous report from a contactable other hcp reported that a 58-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: EL3302 and expiration date: unknown), via intramuscularly in Arm Left on 29Jan2021 at 09:45 (at the age of 58 years old) as a single dose for COVID-19 immunisation. Medical history included allergies to Sulfa drugs from an unknown date and unknown if ongoing, Cardiac stents from 2004 to an unknown date. Concomitant medications included Lipitor, Aspirin, Plavix, Nitroglycerine for an unspecified indication from an unspecified date. No other illness reported at the time of vaccination and up to one month prior. The patient was in observation for 30 minutes. At approximately 25 minutes post vaccination at 10:15am, Patient signaled that he wanted to leave and was instructed to stay 5 minutes. Patient anxious and began to shake, saying he could not breathe. Vitals were 147/88, HR 86, O2 98% on RA. Pt was reclined on floor and reported being cold and was striking his head on the blanket; head stabilized. Patient was alert and oriented X3 but complained of Chest pain. EMS called, arrived at 10:25, vitals: 144/92, HR83 O2 99% on 2L. Pt stable & transported by EMS at 10:35am. The patient underwent lab tests and procedures which included heart rate: 86, 83, investigation: 147/88, 144/92, oxygen saturation: O2 98% on RA , oxygen saturation: 99 % on 29Jan2021. The outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.
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| 58 | 2021-06-01 | pain in extremity |
headache; chills; joint pain; 100.4 fever; injection site swelling; little bit of redness on the sit...
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headache; chills; joint pain; 100.4 fever; injection site swelling; little bit of redness on the site/injection site redness; injection site redness, pain, and swelling; nauseated; pain in the arm/arm started hurting/his arm and all the way up to his jaw was hurting; It felt like he had the flu and he had body aches.; It felt like he had the flu and he had body aches; He felt like what he was experiencing was COVID symptoms.; tiredness; general feeling of unwell; This is a spontaneous report from a contactable consumer (patient's wife) via Medical Information Team. A 58-year-old male patient (Reporter's husband) received first dose of bnt162b2 (FIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0177), via an unspecified route of administration, administered in left arm on 14May2021 in the evening (at the age of 58-years-old) as single dose for covid-19 immunization in pharmacy. Medical history included covid-19 in 2020. Family history included COVID (They all had COVID last year). Concomitant medications included acetylsalicylic acid (ASPIRIN), oral at 81 mg, daily started a couple of months ago and ongoing rosuvastatin at 40 mg, daily, has been taking it for a couple of months; paracetamol (TYLENOL, Strength: 650mg, Lot: SEA002, Expiry: Mar2021) at 650 mg. No additional Vaccines were administered on same Date of the Pfizer Suspect. It was unknown if he had prior Vaccinations (within 4 weeks). When he goes to the doctor he goes by himself. It was reported that reporter's husband had the first dose of the Pfizer Friday and enquired some people say on the second dose the symptoms are worse, if it was true. He had tiredness and had general feeling of unwell on 14May2021; on 15May2021 he had headache, chills, joint pain, 100.4 fever, little bit of injection site redness, pain, and swelling/ injection site swelling, was nauseated. It felt like he had the flu and he had body aches. He went to sleep early on Friday night. She asked if he wanted Tylenol he said no. He mentioned in the middle of the night his arm started hurting. Then in the morning his arm and all the way up to his jaw was hurting. For the past two days their son has been sick and caller hasn't been able to talk to her husband much. He comes home from work and goes to bed. It is unknown if symptoms are ongoing. It was the 8 hour muscle ache and pain. He took Tylenol twice on Saturday. On Sunday, he was feeling better. He felt like what he was experiencing was COVID symptoms. Reporter asked if he could wait a couple of days for getting the second so he can be off work. The second vaccine was scheduled for 04Jun2021. That is a Tuesday and he prefers a Thursday so he could have Friday and Saturday off. A visit to emergency room or physician office was not required. Seriousness for the events was reported as unspecified. The outcome of the events was unknown. Information on the lot/batch number has been requested.
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| 58 | 2021-06-02 | numbness, tingling, pain in extremity |
Left arm was only sore for 36 hours; Within 1 minute throat got ice cold; Difficult to swallow; Fuzz...
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Left arm was only sore for 36 hours; Within 1 minute throat got ice cold; Difficult to swallow; Fuzzy feeling over entire body; Numb face; Tingly feeling; Heavy arms and legs; Light headed, felt very woozy; Blood Pressure went up to 170/120; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Lot number: EN6205), via an unspecified route of administration in the left arm on 05Mar2021 at 11:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included multiple (20 to 30) bilateral knee surgeries and total right knee joint replacement on 02May2020. Concomitant medications included oxycodone 5mg (MANUFACTURER UNKNOWN) as needed, aspirin 88mg/day (MANUFACTURER UNKNOWN) for unspecified indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. On 05Mar2021 (within 1 minute of vaccination), the patients throat got ice cold and more difficult to swallow, fuzzy feeling over entire body, numb face, tingly feeling, heavy arms and legs. Light headed, felt very woozy. It felt exactly like patient had been administered general anaesthesia right before surgery. The patient blood pressure (BP) went up to 170/120 (unspecified unit). As symptoms started getting better after 1 hour, BP went down to 140/70. On an unknown date, the left arm was only sore for 36 hours. It was reported that, emergency medical technician (EMT) did multiple blood pressure checks and electrocardiogram (EKG) at the vaccine site. The patient did not received treatment for adverse events. The clinical outcome of events throat discomforts, swallowing difficult, fuzzy, numbness in face, tingling, heavy feeling in arms and legs, light headed and blood pressure increased was recovered on 05Mar2021 (symptoms were gone after 3 to 4 hours from onset of reaction) and the event pain in arm was recovered on an unknown date (left arm was sore for 36 hours). No follow-up attempts are needed. No further information is expected.
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| 58 | 2021-06-03 | sciatica |
Prior to receiving the vaccine I had mild sciatica. I was able to walk a mile before it bothered me....
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Prior to receiving the vaccine I had mild sciatica. I was able to walk a mile before it bothered me. The pain was perhaps a 3 on a scale of 1 to 10. After receiving the vaccine it became so severe that I was unable to walk or stand for more than a couple minutes, the pain was a 7 on a scale of 1 to 10, and it therefore interfered with daily tasks such as cooking, cleaning, showering, shopping and so on.
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| 58 | 2021-06-04 | tremor |
Earache and Ear Drainage; Dizziness; Chills; Fever; Problems Breathing; Shaking worse than usual; He...
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Earache and Ear Drainage; Dizziness; Chills; Fever; Problems Breathing; Shaking worse than usual; Headache; Nausea; Chest Pains; Soreness; Spitting up Blood; The initial case was missing the following minimum criteria: unspecified AE. Upon receipt of follow-up information on 21May2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for 2 doses. This is the first of two reports for dose 1. This 58-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in left arm on 14Apr2021 (Lot Number: EW0164) at single dose for COVID-19 immunization. The patient's medical history included seasonal allergies and ear trouble. The patient's family medical history was none. The patient's concomitant medication was none. The patient no adverse effect following prior vaccinations. The patient had no other vaccine within 4 weeks. The patient experienced events including earache and ear drainage from 17Apr2021 to 20Apr2021; dizziness from 15Apr2021 to Apr2021; chills and fever from 15Apr2021 to Apr2021; soreness from 15Apr2021 to Apr2021; spitting up blood from 15Apr2021 to Apr2021; problems breathing from 15Apr2021 to Apr2021; shaking worse than usual from 15Apr2021 to Apr2021; headache from 15Apr2021 to Apr2021; nausea from 15Apr2021 to Apr2021; chest pains from 15Apr2021 to Apr2021. The patient stated the symptoms from the first dose started on 15Apr2021 and recovered by 18Apr2021 or 19Apr2021. The patient stated he almost called the ER after the first shot because it was new to him and he did not know what he was dealing with. The events did not require a visit to emergency room neither physician office. All the events except earache did not require treatment. The patient stated he got both vaccines at the beginning of allergy season, but he had no reason to believe it was all from his allergies, it was seemingly related to the vaccine. The outcome of events was resolved.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021580978 same drug/ patient, different dose number/ event
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| 58 | 2021-06-04 | tremor |
Large Amount of Histamine; he still did not feel well/ felt terrible this morning; Earache and Ear D...
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Large Amount of Histamine; he still did not feel well/ felt terrible this morning; Earache and Ear Drainage; Dizziness; Chills; Fever; Soreness; Spitting up Blood; Problems Breathing; Shaking worse than usual; Headache; Nausea; Chest Pains; The initial case was missing the following minimum criteria: unspecified AE. Upon receipt of follow-up information on 21May2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for 2 doses. This is the second of two reports for dose 2. This 58-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in arm left on 05May2021 11:30 (Lot Number: EW0179) at single dose for COVID-19 immunization. The patient's medical history included seasonal allergies and ear trouble. The patient's family medical history was none. The patient's concomitant medication was none. The patient no adverse effect following prior vaccinations. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in left arm on 14Apr2021 (Lot Number: EW0164) at single dose for COVID-19 immunization and experienced events including earache and ear drainage from 17Apr2021 to 20Apr2021; dizziness from 15Apr2021 to Apr2021; chills and fever from 15Apr2021 to Apr2021; soreness from 15Apr2021 to Apr2021; spitting up blood from 15Apr2021 to Apr2021; problems breathing from 15Apr2021 to Apr2021; shaking worse than usual from 15Apr2021 to Apr2021; headache from 15Apr2021 to Apr2021; nausea from 15Apr2021 to Apr2021; chest pains from 15Apr2021 to Apr2021. The patient stated all of the symptoms from the first dose started on 15Apr2021 and recovered by 18Apr2021 or 19Apr2021. The patient stated he almost called the ER after the first shot because it was new to him and he did not know what he was dealing with. The patient had no other vaccine within 4 weeks. The patient received the second dose on 05May2021. The patient experienced earache and ear drainage from 08May2021 to 11May2021; dizziness from May2021 to 18May2021; chills and fever from May2021 to 18May2021; soreness from May2021 to 18May2021; spitting up blood from May2021 to 18May2021; problems breathing from May2021 to 18May2021; shaking worse than usual from May2021 to 18May2021; headache from May2021; nausea from May2021; chest pains from May2021. The patient stated he had the same side effects with both the first and second doses, but with the second shot they were worse and longer. The patient stated he still did not feel well. The patient stated the side effects from the second vaccine started either the 06May2021 or 07May2021 and recovered 18May2021, except the headache, nausea, and chest pain were persisting. The patient stated he felt terrible this morning (21May2021) and he realized this could be from something else. The patient also experienced large amount of histamine; more than usual after the second dose. The events did not require a visit to emergency room neither physician office. All the events except earache did not require treatment. The patient stated he got both vaccines at the beginning of allergy season, but he had no reason to believe it was all from his allergies, it was seemingly related to the vaccine. The outcome of event large amount of histamine; more than usual was resolving. The outcome of event headache, nausea, chest pains, did not feel well/ felt terrible was not resolved. The outcome of other events was resolved.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021582540 same drug/ patient, different dose number/ event
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| 58 | 2021-06-07 | migraine |
I waited 10-15 minutes after receiving the shot and I started to get an overwhelming migraine headac...
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I waited 10-15 minutes after receiving the shot and I started to get an overwhelming migraine headache. I was at the center, so I went to the ER. They put me in a dark room I received a Toradol shot and another shot to get rid of my headache. I was in the hospital for 3 days so they could monitor my migraine. While I was in the hospital, they changed my medicine. I was on 40 mg of Lexapro and they moved me down to 20mg. The first night I was in the hospital was horrible, but I feel that was from the vaccine. I kept pacing back and forth and didn't want to sit down. I do have anxiety and depression. Nothing has really helped with the headaches. I was given medications to take, but I don't remember to take them.
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| 58 | 2021-06-07 | pain in extremity |
arm really sore/ arm hurt all night; "uncomfort" in his arm; This is a spontaneous report from a con...
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arm really sore/ arm hurt all night; "uncomfort" in his arm; This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Batch/Lot number was not reported as patient did not card with him), via an unspecified route of administration, on an unspecified date (at age of 58-year-old) as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient's historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection), via an unspecified route of administration, on an unspecified date as single dose for covid-19 immunization. On an unspecified date, the patient stated that he woke up in the morning with a sore arm after receiving the second dose of the Pfizer COVID vaccine yesterday. He said that he did not have any issues with the first dose. The patient said that he talked to three people as wanted to know if this side effect was normal or if he should seek emergency care from a doctor. The patient had "uncomfort" in his arm and arm was sore. His arm was hurting all night and was uncomfortable. The patient was concerned because he had never experienced this before, and he did not know if he needed to see a doctor for the arm pain. The patient was informed about the role of Pfizer. When probed, patient stated that he was not at his home and did not have vaccination card with him. Product details (ndc# upc# and treatment) and pharmacy details could not be probed as he was unwilling to share further information. Hence, further probing could not be done and limited information available over the call. The outcome of the events was unknown. Follow-up attempts are needed. Further information is expected.
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| 58 | 2021-06-07 | pain in extremity |
sore arm; chest area feels like gas; chest pain/muscle pain in the rib in the chest ribs; chest pain...
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sore arm; chest area feels like gas; chest pain/muscle pain in the rib in the chest ribs; chest pain/muscle pain in the rib in the chest ribs; teeth pain; teeth sensitivity; anxiety; When I take a death breathe it hurts and sometimes it doesn't; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 58-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration (Age at vaccination 58-year) on 07Mar2021 as 1st dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took Advil 12 hours back for arthralgia. The patient stated, she received the first dose of her Pfizer vaccine that morning at 9:45am or 10am. she was fine. she just had a sore arm. About 2 and 1/2 hours later experienced: chest area feels like gas; chest pain/muscle pain in the rib in the chest ribs. Minor issue: teeth pain/sensitivity there. she talked to her PCP and he said she had anxiety, so took CBD oil. She stated "When I lie down the pain wakes me up because of the pain. When I take a death breathe it hurts and sometimes it doesn't. It's been almost 8 hours, there's no gas that I'm passing. I'm eating very light food (it's not due to the food I'm eating). It's a unique experience. Something new. not very severe. Question asked whether to take Advil or pain medicine. I was taking Advil for my joint pain, yesterday last night around 10:30 I took the last dose. Today I didn't take anything. Question asked if I should monitor for anything else." On 07Mar2021 the patient experienced sore arm, chest area feels like gas, chest pain/muscle pain in the rib in the chest ribs, teeth pain, teeth sensitivity, anxiety and when I take a death breathe it hurts and sometimes it doesn't. Therapeutic measures were taken as a result of anxiety. The clinical outcome of the events was unknown. No follow-up attempts are possible. Information about lot/batch number cannot be requested. No further information is expected.
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| 58 | 2021-06-08 | pain in extremity |
Patient complained of having full body aches and joint paint (multiple joints affected: knees, ankle...
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Patient complained of having full body aches and joint paint (multiple joints affected: knees, ankles, toes, hands, wrist and elbows) and continued arthritis type symptoms.; Patient complained of having full body aches and joint paint (multiple joints affected: knees, ankles, toes, hands, wrist and elbows) and continued arthritis type symptoms.; Patient complained of having full body aches and joint paint (multiple joints affected: knees, ankles, toes, hands, wrist and elbows) and continued arthritis type symptoms.; Patient complained of having full body aches and joint paint (multiple joints affected: knees, ankles, toes, hands, wrist and elbows) and continued arthritis type symptoms.; This is a spontaneous report from a contactable consumer or other non-healthcare professional. This consumer reported for a 58-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date, patient complained of having full body aches and joint paint (multiple joints affected: knees, ankles, toes, hands, wrist and elbows) weeks after taking 2nd dose of COVID vaccine and continued arthritis type symptoms. It was reported that onset linked to after 2nd dose of vaccine and no other changes in diet, medications or physical exercise attributed to joint pain. Event took place after use of product. The outcome of event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 58 | 2021-06-09 | night sweats |
lost of the sense of smell; diarrhea one day; hot and cold sweats; stuffy nose; Headache; night swea...
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lost of the sense of smell; diarrhea one day; hot and cold sweats; stuffy nose; Headache; night sweats; They are wondering did they get COVID from the shot or should they have been tested before they got the shot; This is a spontaneous report from a contactable consumer reported for a male patient via medical information team. A 58-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection; Lot number and expiration date: Unknown), via an unspecified route of administration in the upper left arm on 18Feb2021 at 16:00 (at the age of 58-year-old) as 1st dose, single dose for COVID-19 immunization. Medical history included asthma growing up as a child. It was an underlying medical condition and high blood pressure. No investigation assessment was not provided. Concomitant medication included Metoprolol for high blood pressure and one other but doesn't know the name of the other one. Patient also took a water pill. The patient did not receive any other vaccines within four weeks prior to the vaccination. Consumer reported that patient received first dose of COVID vaccine on 18Feb2021. He had symptoms ever since. The reporter wanted to know did he get COVID from the shot or should he have been tested before he got the shot and how long would the side effects could last. The reporter clarified patient symptoms as lost sense of smell, stuffy nose, hot and cold sweats, diarrhea one day, night sweats and headache on an unknown date in Feb2021. She mentioned that she finds it strangely coincidental that they received the shot and then "all of the sudden they can't smell". The vaccination card given to him was in the car. The reporter doesn't have it on hand to provide lot number. It was given on the same date and at the same time as consumer, so probably the same lot number she received. Consumer's lot number was EN6200. No adverse events resulted in physician's office visit nor emergency Room. The events were assessed as non-serious. The clinical outcome of events was reported as unknown. No follow-up attempts are possible. No further information is expected.
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| 59 | 2021-01-03 | facial paralysis, tingling |
Patient received his vaccine and waited the 15 minute observation period before leaving the clinic. ...
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Patient received his vaccine and waited the 15 minute observation period before leaving the clinic. At 2:00 he returned to the clinic, stating to the paramedic that he felt like he was having an episode of Bell's Palsy. His vital signs were checked and were as follows: BP 169/96 mmHg, HR 72 bpm, O2 sat 99%. The patient has right sided tingling extending from the eye to the mouth. He had no visual changes. The patient was offered transport to the hospital and further medical treatment. He refused transport or treatment and left the vaccination clinic.
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| 59 | 2021-01-05 | discomfort, pain in extremity |
"I've got 1st vaccination shot at 11 am 12/21/2020. Got moderate (3 to 5 on 10-steps scale) pain ...
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"I've got 1st vaccination shot at 11 am 12/21/2020. Got moderate (3 to 5 on 10-steps scale) pain in left upper arm/shoulder around 9 pm, limited mobility. Took 2 extra-strength Tylenols. Between 2 and 3 am woke up because of severe headache (7 to 8), couldn't normally sleep because of that. Temperature 99.6 F. Another 2 Tylenols about 4 am. Not effective. Drinking a lot of water. Decided to stay home. Contacted my supervisors by text and e-mail, left a voice message for EH. 8 am - another 2 Tylenols. Tried to sleep - slept till 1 pm. Headache improved (3-5), 99.3 F. Water and tea, minimal activity. Received instructions from EH - to stay at home if any symptoms will take place, to get COVID test upon returning to the hospital. Condition was improving during the day. Low pain and discomfort in the evening (2-3). Sleeping normally during the night. No symptoms in the morning. No reason to delay returning to work. Took COVID test at 9 am. Negative. No symptoms since then"
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| 59 | 2021-01-06 | tingling, pain in extremity | Sore arm, tingling in hand and fingers. severe nausea and head ache. fatigue |
| 59 | 2021-01-07 | pain in extremity, numbness |
Got the vaccine in left arm on 12/31, sat for 15 minutes for observation. After leaving and driving ...
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Got the vaccine in left arm on 12/31, sat for 15 minutes for observation. After leaving and driving home, started feeling worse pain in left arm and numbness around the left ear and left cheek. Went back, they examined and observed for another hour, then released. It went away and returned; has been intermittent since. Left V2/3 distribution
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| 59 | 2021-01-07 | pain in extremity |
Dizziness, Constipation, Extreme Fatigue, pain in arm form shot Narrative: Significant impact on li...
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Dizziness, Constipation, Extreme Fatigue, pain in arm form shot Narrative: Significant impact on life as he missed work due to this
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| 59 | 2021-01-09 | flushing |
59 year male with history of HTN, became flushed and dizzy 7 minutes after vaccine. BP 170/100 P 78...
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59 year male with history of HTN, became flushed and dizzy 7 minutes after vaccine. BP 170/100 P 78 O2 sat 97-99%. Denied SOB.
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| 59 | 2021-01-10 | flushing, cold sweat, tingling |
Vaccine recipient developed headache, dizziness, fogginess, feeling flushed, cold sweats and a weird...
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Vaccine recipient developed headache, dizziness, fogginess, feeling flushed, cold sweats and a weird tingling sensation hours after receiving the vaccine. He also noted developing mental confusion. He did not have to go to the ED and went home for the rest of the day. For 1.5 days, he was home resting. On a follow-up call on 1/11/2021, vaccine recipient reported feeling better. Pfizer-BioNTech COVID- 19 Vaccine EUA.
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| 59 | 2021-01-11 | numbness and pain in extremities, sensory loss |
Received vaccine on Saturday 1/9/21, had usual symptoms low grade fever, general malaise. On Sunday ...
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Received vaccine on Saturday 1/9/21, had usual symptoms low grade fever, general malaise. On Sunday begin to experience left arm neuropathy at the media aspect of elbow, no sensation in affected area. Lateral aspect is fine, can move fingers and complete activities of daily living.
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| 59 | 2021-01-12 | numbness |
Symptoms were first noted on 12/22/2020 in 15 minutes after getting the Covid Pfizer vaccine. He had...
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Symptoms were first noted on 12/22/2020 in 15 minutes after getting the Covid Pfizer vaccine. He had numbness of his face and right hand. It resolved in two hours. He did have soreness for two days after the vaccine. He did not have any other symptoms like rashes or difficulty breathing. He could lift his arm. It made him a little nervous. It was bad enough that he pulled over from the freeway and rested for a few hours. He used an ice pack that helped the soreness, but this was after then numnbness resolved.
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| 59 | 2021-01-12 | pain in extremity |
"Pfizer-BioNTech COVID-19 Vaccine EUA". Symptoms: Tiredness throughout day at approx 2 hrs after va...
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"Pfizer-BioNTech COVID-19 Vaccine EUA". Symptoms: Tiredness throughout day at approx 2 hrs after vaccination. Felt feverish around midnight, headache, some nausea, pain on arm where vaccination was applied, overall upper discomfort, joint pain (shoulders) and kind of disoriented. Took Tylenol Extra Strength, 500mg, to ease the discomfort.
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| 59 | 2021-01-17 | pain in extremity |
Had my 2nd COVID vaccination shot at 2 pm on Monday, January 11, 2021. Next morning - moderate pa...
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Had my 2nd COVID vaccination shot at 2 pm on Monday, January 11, 2021. Next morning - moderate pain in upper left arm/shoulder (place of injection). Working full shift. Around 4 pm on Tuesday (after almost 3hrs OR case) - feeling very tired. Completed the working shift at 6 pm. Minor to moderate headache started to develop later in the evening. Two pills of Tylenol at 9 pm, another two around 2 am - while headache was getting worse. @6:30 am Wednesday - informed managers that I'll have to stay off work because of bad headache (7 to 8 from 10), called EH as well. During the day - mostly staying in the bed. Tylenol, water, tea with lemon, apples for hydration. Headache -- up and down (between 4 and 8), occasional fatigue and nausea (after staying upright more than 10-15 minutes), left upper arm pain, moderate pain in joints (knees, hips, low back). No fever. Troubled night-time sleeping because of headache. 7 am - informed managers and EH about my condition, Got approval for another day off - with request to have a C-Test after that. Similar feeling and treatment. Slow improvement during the day. Around 5 pm - feeling good enough to start moving more actively, headache and shoulder pain on low level, though getting tired quickly still. Much better sleeping. No symptoms in the morning. Had a COVID test before returning to work.
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| 59 | 2021-01-20 | weakness |
onset of left sided mouth numbness & weakness associated with change in taste but no change in se...
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onset of left sided mouth numbness & weakness associated with change in taste but no change in sense of smell over the past 2 days- woke up 2 days ago with subtle changes to the left mouth - no associated other symptoms of headache, sore throat ear pain or drainage & no skin lesions to the nose, ear or left cheek; no stiff neck , sore throat, fever, chills, rigors * no recenbt URI symptoms or trauma to the left ear ie using Qtips; denies prior similar symptoms & no associated visual changes , double vision or partial visual field changes ie amuarosis fugax, teichopsia or pallisading;
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| 59 | 2021-01-20 | feeling hot | hot and sweaty lasting two minutes after rash |
| 59 | 2021-01-20 | pain in extremity |
next day was very tired with a slight headache; next day was very tired with a slight headache; 12 h...
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next day was very tired with a slight headache; next day was very tired with a slight headache; 12 hours after the injection I got the chills while I was in bed trying to sleep; I did not sleep well that night; 4 hours after the injection my arm was very sore; This is a spontaneous report from a contactable consumer. A 59-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 30Dec2020 09:00 at single dose at left arm for COVID-19 immunization. Medical history included none. There were no concomitant medications. The patient reported 4 hours after the injection/reported as 30Dec2020 14:00, my arm was very sore. On 30Dec2020 21:00, 12 hours after the injection, "I got the chills while I was in bed trying to sleep. I did not sleep well that night. The next day (31Dec2020) was very tired with a slight headache. The patient only rested all day. The next day he felt better but was slightly fatigued all day. The day after that the patient was back to being himself. His arm continued to be sore for a total of 5 days. The patient did not receive treatment for the events. The outcome of the events was recovered. Information on the Batch/Lot number has been requested.
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| 59 | 2021-01-20 | pain in extremity |
Had first injection in the upper left arm and now arm is still extremely sore and makes for restless...
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Had first injection in the upper left arm and now arm is still extremely sore and makes for restless sleep. Second injection done in right arm and know soreness except slight at injection site if touching it.
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| 59 | 2021-01-20 | tingling |
3 days after vaccine, second dose given on day 16, developed ascending paresthesia, no weakness, up ...
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3 days after vaccine, second dose given on day 16, developed ascending paresthesia, no weakness, up to abd from LEs and to elbows on BUE
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| 59 | 2021-01-25 | pain in extremity, weakness |
EVENINING OF 1ST DOSE - LEFT ARM AND SHOULDER WAS EXTREMELY SORE. MIDNIGHT - NECK STARTED HURTING AN...
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EVENINING OF 1ST DOSE - LEFT ARM AND SHOULDER WAS EXTREMELY SORE. MIDNIGHT - NECK STARTED HURTING AND FELT A FLASH HEADACHE. SOON AFTER, BACK STARTING HURTING, (LOWER RIGHT & LEFT FLANKS OF BACK), NECK AND LEGS FELT WEAK. 9AM NEXT DAY, HEADACHE RETURNED.
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| 59 | 2021-01-25 | unresponsive to stimuli, seizure |
On 1/4/21 Client had what appeared to be a seizure and went unresponsive. He foamed from the mouth a...
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On 1/4/21 Client had what appeared to be a seizure and went unresponsive. He foamed from the mouth and turned blue. O2 Sat was in the 60's, O2 was applied previous to paramedics arrival. BP was high. Unresponsive for 30 minutes. When he woke he did not recognize anyone, did not know where he was at or what day of the week it was. He was transported to the Hospital. Multiple tests were ran and nothing out of the ordinary was found. Started seizure medication.
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| 59 | 2021-01-27 | pain in extremity |
Chronic acute systemic pain now at much higher pain levels. Tendinitis in right arm was at 3, now at...
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Chronic acute systemic pain now at much higher pain levels. Tendinitis in right arm was at 3, now at 7. Back and neck was at 6, now at 9. Hips and knees were at 5 now at 7.5.
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| 59 | 2021-01-28 | numbness | Dizziness, numb hands, heavy tongue, and somnolence |
| 59 | 2021-01-28 | tingling | Pt developed palpitations, tingling of left sided face, vomiting |
| 59 | 2021-01-29 | pain in extremity |
On day 04 After receiving the 2nd Covid 19 Pfizer vaccine, I experienced a deep pain in my upper inn...
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On day 04 After receiving the 2nd Covid 19 Pfizer vaccine, I experienced a deep pain in my upper inner right thigh around 0600 am of the 16th of January. At the same time my calf muscle of that same right leg was in pain. I thought it to be muscular pain as I was told by the reading material regarding symptoms of the covid 19 vaccine there could be aches an pains attributed to the 2nd shot. I used a deep heating rub on both areas of my right leg and put heat on them to treat the soreness. This occured over the next few days feeling this pain in my right leg and treated the same way applying heat. Within about 24 hours of the pain in my legs I started experiencing a shortness of breath while walking up and down st. On day 04 After receiving the 2nd Covid 19 Pfizer vaccine, I experienced a deep pain in my upper inner right thigh around 0600 am of the 16th of January. At the same time my calf muscle of that same right leg was in pain. I thought it to be muscular pain as I was told by the reading material regarding symptoms of the covid 19 vaccine there could be aches an pains attributed to the 2nd shot. I used a deep heating rub on both areas of my right leg and put heat on them to treat the soreness. This occured over the next few days feeling this pain in my right leg and treated the same way applying heat. Within about 24 hours of the pain in my legs I started experiencing a shortness of breath while walking up and down stairs as part of my daily activities. The symptoms of shortness of breath only seemed to appear when I was on any form of extended walking activity or physical movements or exercise this would of have been starting around the 17th of January. The right leg pain was masked by the heating rub while the shortness of breath continued for the next few days. On the 19th of January, I went to an Urgent Care Facility at 0800 am to see a Medical professional to discuss my symptoms I was previously experiencing and to figure out why I was having a shortness of breath and the pain in my right leg. The on staff Physician's Assistant had a Nurse conduct a Covid 19 Rapids test (negative) and a second swab was administered and sent to the Lab. Which produced a (negative for Covid 19) on the 20th of January. An Xray was not taken to determine my shortness of breath. The Dr listened to my lungs and heart, though I did let the PA know I had received both Pfizer shots and when they were administered. I was carrying My Shot record for the vaccine with the dates and lot number. He didnt appear to be interested in further diagnosis and made sure I had the paperwork to track the results of my Covid swab sent to the lab. The visit was completed and I was released to go back to work/home. I carried on the symptoms of the shortness of breath from the 19th of January to the 22nd of January monitoring my O2 (oxygen levels) with a pulse oximeter. They ranged from 90-93. On the evening of the 22nd of January I was becoming very uncomfortable with my breathing climbing the stairs in my home and monitored my O2 readings with the oximeter on my finger when walking upstairs and they dropped down to 60-65. My wife drove me to the emergency room at Hospital. I walked into the ER and checked myself in for shortness of breath and leg pain in my right leg. I was admitted into the emergency room and put on 15 litres of oxygen. The emergency room Dr ordered a chest Xray, Cat Scan of my chest and heart and a sonogram of my right leg. The testing results came back with a noted large pulmonary emboli on my lungs/heart area and blood clots throughout my right leg (right lower extremity DVT). Surgery was performed to remove the pulmonary emboli and I was put on a Heprin Drip to thin out my blood for the remaining clots in my chest and my right leg. The attending physician ordered a T.E.E. (transesophageal Echocardiogram) to observe my heart functions. I was told the TEE did not demonstrate any further recommend surgeries. I was administered a test for my cardio and heart functions prior to my discharge on 27 January 2021. I was prescribed Eloquis for maintenance medication to be monitored by followup visits to my cardiologist and Hemotologist within the next few weeks. I have not family or personal history of Blood Clots. I do perform administrative duties as part of my job, which requires sitting and working on a computer. Note however I move around very often during a work day and operate a farm tractor and have an active life style. I have not recently had any extended trips more than 2 hours nor have I flown within the past year or so.
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| 59 | 2021-01-31 | weakness |
Sudden light headedness, room spinning, increased heart rate, slight ringing in the ears. Weakness....
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Sudden light headedness, room spinning, increased heart rate, slight ringing in the ears. Weakness. Lasted about 15 minutes. Felt mildly lightheaded, and had loss of energy symptoms for about 12 hours. Felt good for about 1hour after that then a second episode happened about 10pm. The second episode was about half as severe as the first and only lasted about a minute or two. Woke up this morning 02/01/2021 feeling fairly normal.
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| 59 | 2021-02-03 | pain in extremity | Swollen painful toes 5 days |
| 59 | 2021-02-09 | inability to speak, slurring, tingling, one side paralysis |
On Saturday 2/6 unwitnessed fall without loss of consciousness. Gait was unstable, weakness on righ...
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On Saturday 2/6 unwitnessed fall without loss of consciousness. Gait was unstable, weakness on right side (RUE, RLE) slurred speech, difficulty with finding words. Transported by POV to ED for evaluation of stroke - same sx with onset of parasthesia in right upper arm. Stroke protocol done - received tPA with resolution of symptoms during infusion. Stayed in hospital until protocol completed. Symptoms resolved over the course of the hopsitalization.
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| 59 | 2021-02-10 | weakness |
Patient experienced generalized weakness and was unable to support himself. Patient was taken to hos...
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Patient experienced generalized weakness and was unable to support himself. Patient was taken to hospital ER. Patient has a history of episodes of weakness. ER diagnosed patient as having an allergic reaction to COVID-19 Vaccine. He was discharged to this group home.
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| 59 | 2021-02-17 | feeling cold |
12 hours after vaccine started having chills-could't get warm. 15 hours after vaccine developed sev...
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12 hours after vaccine started having chills-could't get warm. 15 hours after vaccine developed severe vomiting for about 7 hours.
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| 59 | 2021-02-17 | pain in extremity |
Chest pain; shortness of breath; pain radiating down left arm; This is a spontaneous report from a c...
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Chest pain; shortness of breath; pain radiating down left arm; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received the second dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine), via an unspecified route of administration on 06Feb2021 12:00 at single dose in left arm for COVID-19 immunisation. Medical history included allergies to iodinated contrast, chronic lymphocytic leukaemia (CLL), herniated discs. The patient didn't have COVID prior vaccination. Concomitant medications included tamsulosin hydrochloride (FLOMAX), sertraline hydrochloride (ZOLOFT), valacyclovir, ascorbic acid, betacarotene, biotin, calcium, chromium, colecalciferol, copper, folic acid, iodine, iron, lycopene, magnesium, manganese, nicotinamide, pantothenic acid, phosphorus, phytomenadione, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, vitamin b1 nos, vitamin b12 nos, vitamin e nos, xantofyl, zinc (CENTRUM SILVER). The patient previously received the first dose of bnt162b2 on 16Jan2021 02:00 PM in left arm for COVID-19 immunisation. There were no other vaccine in four weeks. The patient experienced chest pain, shortness of breath, pain radiating down left arm. Adverse events start from 07Feb2021 05:45 AM. The events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, and hospitalization for 1 day. Treatment was received for the events. The patient underwent lab test which included Blood tests, EKG on unknown date. The outcome of the events was recovering. COVID was not tested post vaccination. Information on Lot/Batch has been requested.
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| 59 | 2021-02-22 | weakness, pain in extremity | 2 days later developed chest tightness, left arm pain, weakness, HTN |
| 59 | 2021-03-07 | pain in extremity |
arm is sore; little muscle soreness; This is a spontaneous report received from a contactable consum...
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arm is sore; little muscle soreness; This is a spontaneous report received from a contactable consumer (patient). A 59-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, on 05Feb2021, at single dose, for COVID-19 immunization. Medical history included being disabled. The patient's concomitant medications were not reported. The patient reported he had his shot on 05Feb2021. In Feb2020, his arm was sore and had a little muscle soreness. The patient stated that he goes to the gym and has a hard work out and asked if it was okay to take Tylenol or Motrin. The outcome of the events was unknown. Information on the lot/batch number has been requested.
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| 59 | 2021-03-08 | tremor, pain in extremity |
Maybe Important: I had COVID-19 Oct 2020 for 4 weeks, bad case, still have deep breathing issues, s...
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Maybe Important: I had COVID-19 Oct 2020 for 4 weeks, bad case, still have deep breathing issues, shortness of breath and get tired much quicker than I used to (I'm an avid Tennis player, several times a week). Shot Info: from 3/5 10am to 3/6, no issues, I didn't even feel the shot, no soreness or other symptoms. woke up at 2am (first noticed): Very sore arm, Sore from head to toes, headache, sever chills/shaking, very tired, severe shortness of breath, joints (knees, hips, wrist) constant (not overly severe) pain. Severe symptoms lasted for 24 hours before starting to taper off, felt pretty good by Sunday 3/7 12pm/Noon. My chills were so bad, just getting up to go to the restroom 15 ft away, didn't know if I could make it back to the bed. Headaches was the last thing to go.
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| 59 | 2021-03-11 | pain in extremity |
Pain at injection site. It has progressed to severe shoulder and arm pain starting 03/08/2021 that i...
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Pain at injection site. It has progressed to severe shoulder and arm pain starting 03/08/2021 that is still increasing
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| 59 | 2021-03-11 | tremor |
General Fatigue during the day went to sleep and had terrible shivers to violent shaking. Fell bac...
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General Fatigue during the day went to sleep and had terrible shivers to violent shaking. Fell back asleep and then awoke to being being drench. Cotton pajamas were thoroughly wet as was bedding. It would have taking a pint or two of water to have made this wetness. [and no it was no urine! ;) ] had to get new pajamas and throw a towel on the bed to have dry bedding.
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| 59 | 2021-03-12 | weakness |
Immediate after the shot i had a weird taste and slight feeling of nausea which soon went away. Ar...
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Immediate after the shot i had a weird taste and slight feeling of nausea which soon went away. Around 6 pm on the day of the injection I noticed that my taste buds were more sensitive. Following that I became very sluggish. So I went to bed shortly afterwards. The following morning I was still sluggish and there was a feeling of openness in my upper chest area. The feeling of tiredness an no energy started and continued until Wednesday the 3rd of March. That morning I awaken feeling better. I still have a feeling of openness in my upper chest area. But overall I feel great.
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| 59 | 2021-03-13 | numbness | Numbness on left side of face |
| 59 | 2021-03-14 | pain in extremity |
Headache; Chills; Body aches; Sore arm; This is a spontaneous report from a non-contactable consumer...
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Headache; Chills; Body aches; Sore arm; This is a spontaneous report from a non-contactable consumer (patient). A 59-year-old male patient received BNT162B2 (Lot Number: EL3248), via an unspecified route of administration in left arm, on 02Feb2021 at 07:00 AM, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. On 02Feb2021 at 11:00 PM (23:00), the patient experienced headache, chills, body aches, and sore arm. The events were considered non-serious. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from the events in Feb2021. No follow-up attempts are possible. No further information is expected.
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| 59 | 2021-03-15 | burning sensation |
About 32 hours after given the shot, chills, fever and nausea began. This quickly escalated to not b...
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About 32 hours after given the shot, chills, fever and nausea began. This quickly escalated to not being able to breath. Face and neck were turning purple. My dad was about to call 911 when he finally was able to calm down and catch his breath. His lungs and chest burned afterwards and he was completely spent for days after.
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| 59 | 2021-03-15 | tingling |
Pt. was in observation lane. Was feeling dizzy and tingling on arm. BP was 150/89. Paramedic asse...
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Pt. was in observation lane. Was feeling dizzy and tingling on arm. BP was 150/89. Paramedic assessed pt. Once symptoms subsided, pt. was released to go home.
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| 59 | 2021-03-17 | pain in extremity |
Pfizer-BioNTech COVID-19 Vaccine EUA Approximately three weeks after this injection, I began to fee...
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Pfizer-BioNTech COVID-19 Vaccine EUA Approximately three weeks after this injection, I began to feel a pain in my left leg. I assumed it was a cramp. I then received a second dose (Lot # EN6206) on 3/13/21. Over that weekend the pain in my leg grew worse and the leg began to swell. on 3/15, I went to my primary care physician who said it looked like a blood clot. He sent me to a radiologist for an ultrasound (?) of the leg. After confirming the clot, I went to a local ER. They started me on Eliquis to treat the clot
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| 59 | 2021-03-17 | tingling, burning sensation | Tingling , burning sensation in legs and feet. |
| 59 | 2021-03-17 | unresponsive to stimuli, tremor |
Pfizer-BioNTech COVID-19 Vaccine EUA Pt chronic schizophrenia with subsequent mild cognitive impairm...
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Pfizer-BioNTech COVID-19 Vaccine EUA Pt chronic schizophrenia with subsequent mild cognitive impairment over the past year who was brought to hospital after 4 days of food/medication refusal, withdrawal from care and more recently disorientation and tremor. Pt was recently transitioned from haldol decanoate to clozapine. Last dose haldol decanoate was on 2/16/21. First dose clozapine 12.5 mg was on 2/24/21. Increased to 12.5 BID the following day. Increased to 25 mg BID on March 2, without reported side effects or other issues. Pt got his first dose of Pfizer COVID vaccine on March 4, and that night was less engaged with staff, felt feverish. Did not spike a temp per bedside accompaniment who was with him that day. The following day, he barely ate any food and did not get out of bed all day. This continued for the entirety of the weekend - bed bound, turning to look at staff when called but did not engage/respond verbally. He was incontinent of urine over the weekend. Treated for Neuroleptic malignant syndrome 2/2 clozapine Uncertain if vaccine contributed to event, but recent case report published relating clozapine toxicity and Pfizer COVID vaccine, so submitting to VAERS for evaluation
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| 59 | 2021-03-19 | tremor |
At 7:00 pm I started experiencing sinus drainage & stuffiness. When I went to bed at around 8:30 P.M...
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At 7:00 pm I started experiencing sinus drainage & stuffiness. When I went to bed at around 8:30 P.M. I Noticed some difficulty getting enough air into my lungs ( 11/2020 Ablation for A fib, compromised phrenic nerve Not usually SOB unless high physical demand ) At 9: 30 P.M started moderate shacking/Chills until around 3 A.M. with little sleep. Then some sleep until 5:00 A.M. woke up with 102.4 temp and felt lousy with joint pain in various joints that do not typically hurt. Did not go to work spent most of the day in bed until 4:00 P.M. Feeling somewhat better now
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| 59 | 2021-03-23 | numbness, tingling |
Patient had vaccine 1/28/2021. Two days later developed left sided abdominal pain that was severe e...
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Patient had vaccine 1/28/2021. Two days later developed left sided abdominal pain that was severe enough to warrant multiple ER visits, one admission, multiple negative tests including but not limited to CT scan and endoscopy. He lost 30 pounds. In the beginning of March he began noticing tingling and numbness in arms and legs which has progressed to paralysis of his bilateral lower extremities. He is now hospitalized for same and has a working diagnosis of CIDP (chronic inflammatory demyelinating polyneuropathy).
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| 59 | 2021-03-24 | pain in extremity, cold sweat |
Very sore arm. Cold sweets. Elevated temp for 2 days reaching 101.5 degrees. Sick stomach. Nearly pa...
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Very sore arm. Cold sweets. Elevated temp for 2 days reaching 101.5 degrees. Sick stomach. Nearly passed out one evening when I got up out of bed. Nearly didn't make it back to bed. Body aches. Used cold compresses and took extra strength Tylnol and Aspirin. Lots of water and Ensure. Dressed in layers to stay warm. My wife and I are sick at the same time from vaccine injection. Missed 2 days of work. Also had skjn hypersensitivity in my upper back. Had fatuque, but not as bad as my wife.
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| 59 | 2021-03-24 | pain in extremity |
Severe fever lasting still on day 5 most days over 100 brought down only with ibuprofen, dizzy and l...
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Severe fever lasting still on day 5 most days over 100 brought down only with ibuprofen, dizzy and lightheaded that prevents me from working and driving. I've missed 2 days of work so far. Soreness continues in my arm as well. I've also had nausea at times and appetite that varies.
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| 59 | 2021-03-25 | inability to speak |
Dizzy, vertigo, difficulty breathing immediately after shot. Dizziness subsided after a few hours, t...
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Dizzy, vertigo, difficulty breathing immediately after shot. Dizziness subsided after a few hours, typical arm pain at the injection site a few days after. Fatigue and difficulty breathing increased over the next few days. On the third day after injection, experienced cognitive difficulty using words, vertigo. Went to emergency for possible stroke symptoms. Cognitive testing, Brain CT scan w/contrast, MRI, Echocardiogram, 24 hour in patient observation. All negative. Still experiencing shortness of breath and anxiety a week after injection.
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| 59 | 2021-03-25 | bell's palsy |
3/18/2021 I noticed that I could not clear my ear the next morning my eye lid felt like it was dragg...
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3/18/2021 I noticed that I could not clear my ear the next morning my eye lid felt like it was dragging across my right eye and I developed Severe pain in and around my left ear running down into my neck. Shortly later I had less and less control of the right side of my head, now I can't move it. I have since discovered that I have Bell's Palsy due to the vaccine. I didn't know what it was until I went to the doctor as this has never happened to me before.
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| 59 | 2021-03-25 | pain in extremity |
At 11pm that evening headache (worst ever in my life), joint pain in hands, hips, knees, muscular pa...
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At 11pm that evening headache (worst ever in my life), joint pain in hands, hips, knees, muscular pain in thighs and lower back, lasting about 6 hours. Diminished gradually over the next 4 hours. Fatigue ongoing.
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| 59 | 2021-03-25 | tingling |
Feet and legs Tingly like falling asleep. Pins needles also occasionally all over. Head feels press...
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Feet and legs Tingly like falling asleep. Pins needles also occasionally all over. Head feels pressure like sinus but not sinus. Hands feel slight vibration like small amount of electricity going through my body. No symptoms felt while laying in bed. Start in the morning when moving around.
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| 59 | 2021-03-26 | discomfort |
Left arm very sore about 8 hours later and the next day. Discomfort stopped around 12 noon 2nd day. ...
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Left arm very sore about 8 hours later and the next day. Discomfort stopped around 12 noon 2nd day. Also, 2nd day, sluggish and exhausted beyond normal after my work day (PT 1:30 to 5:30 pm.)
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| 59 | 2021-03-28 | hypersensitivity of all senses |
Stiff arm immediately, Stiff neck left side 24 hours after, Shingles presents 48 ours after inject...
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Stiff arm immediately, Stiff neck left side 24 hours after, Shingles presents 48 ours after injection on scalp left side from center line top to neck coving all of hair line with touch sensitivity. Rash begins on left side jaw, cheek and under chin 24 hours later. Rash continues to spread to all of scalp, and behind ear and around back of neck. Blisters follow and pain increases. First suspected an allergic reaction but after no response to Benadryl and increased pain sought medical care and was confirmed Shingles. Treaded with Valacyclovir and has responded well to treatment.
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| 59 | 2021-03-29 | numbness |
I received my second vaccine yesterday. Approximately half an hour after receiving the vaccine, I de...
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I received my second vaccine yesterday. Approximately half an hour after receiving the vaccine, I developed numbness in my left cheek. It subsided within about 90 minutes. I had a more intense reaction after my first vaccine, when my left cheek, jaw, left arm and leg felt numb. When I got the first vaccine it felt like the needle hit the bone and like the injection was into the shoulder joint. The second vaccination as a little bit lower down.
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| 59 | 2021-03-30 | tingling |
miniature shocks like pins needles that goes up his back and into his neck; This is a spontaneous r...
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miniature shocks like pins needles that goes up his back and into his neck; This is a spontaneous report from a contactable consumer. A 59-year-old male patient received second dose of BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Right on 22Feb2021 (Batch/Lot Number: EN5318) as single dose for covid-19 immunization. The patient's medical history includes dental work in Dec2020. There were no concomitant medications. The patient was previously administered first dose with BNT162B2 for covid-19 vaccination (Lot number EL9261, expiration unknown, Right Arm, (First dose). The patient also previously used novocaine (he had dental work in Dec2020 and stated that they only gave him Novocaine). The patient experienced miniature shocks like pins needles that goes up his back and into his neck on 28Feb2021. Reporter states that he is experiencing little miniature shocks like pins needles that goes up his back and into his neck. It has never been below his waist. They are not in his arms, legs, or head. It is like is annoying pricking like when you have been in contact with fiber glass. It does not hurt or itch, it is a tingling sensation. He never had it before or any blood or breathing issues. He said that he has not had any other medications, a change in diet, or been exposed to anything hazardous. He said that he had dental work in Dec2020 and stated that they only gave him Novocaine and it did not affect him like this. The outcome of the event was not recovered.
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| 59 | 2021-03-31 | discomfort, weakness |
He will keep him up until 3 in the morning and he stays awake; headache; it is really frustrating; p...
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He will keep him up until 3 in the morning and he stays awake; headache; it is really frustrating; pain in his joints and his bones and it was getting worse; pain in his joints and his bones and it was getting worse; pain all over; Any place in his body, his muscles, joints, and bones have had pain previously/ pain in his joints and his bones and it was getting worse/ pain all over on the day after his COVID vaccine; body is so weak/ doesn't have any energy to move; tired; a little bit of small itching, not much, just a little bit that made him feel not comfortable with it; a little bit of small itching, not much, just a little bit that made him feel not comfortable with it; ribs moving quicker; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received first dose of BNT162B2, via an unspecified route of administration (left arm) on 06Mar2021 at a single dose for COVID-19 immunisation. Medical history included pain, high cholesterol, and testosterone low, joint pain, bone pain, muscle pain, any place in his body had pain, and doesn't have good memory, all ongoing. Concomitant medications included ongoing hydrocodone for pain, ongoing atorvastatin for high cholesterol, ongoing clomiphene citrate for testosterone medication because it was low because of his age, ongoing colecalciferol (Vitamin D), ongoing ascorbic acid (Vitamin C), ongoing oxycodone for pain, and unspecified eye medication. He had many different medications that he was taking. Historical vaccines included chicken pox vaccine for immunization and shingles vaccine in Jan2020 for immunization and experienced pain all over. The patient stated that he was a torture survivor and he has been taking pain medication because of him being tortured previously. He was taking medications for the pain, clarified to be hydrocodone and oxycodone. These medications kept his body stable. He was able to sleep and relax. One day after he received his Pfizer COVID vaccine (07Mar2021), he started feeling the pain in his joints and his bones and it was getting worse but the pain used to be stable with the way he was using his medicines. But now his body was not stable. Any place in his body, his muscles, joints, and bones have had pain previously because of the damage of torture but now it all came up after the COVID vaccine. Every piece of his body hurt even if he takes his medications. He still had the pain and his body was so weak for about 4 to 5 hours. He used to be able to do his business all day but now after about 3 to 4 hours on his feet he got so tired and he needed to sit. He didn't know why this happened. He has talked to others that have received COVID vaccines and none have had this kind of reaction like him. He has asked them about it. It was very frustrating to him on an unspecified date. Every month he sees a physician. He would like for Pfizer to contact him with further questions, he can't understand the pain. This was really killing him especially when the pain goes to his bones. He will keep him up until 3 in the morning and he stays awake on an unspecified date. He then took medicine and he had to wait for 30 minutes for it to start working and then he will be able to sleep. But other than that, the pain jumped. He has had the chicken pox and the shingles vaccines and none did like that. The pain was not going away in his muscles or joints. And now he was getting a headache on an unspecified date, it was really frustrating. He didn't have good memory from the torture. This morning, when he woke up, he had the pain in his joints and his bones. He didn't like to use too much medication. He liked to use it only as he needs it. Pain medications are strong. But this COVID vaccine somehow made him need to use more medication and then that caused him to have a headache. His pain should get better with his medications but today, he had pain all over him and he didn't have any energy to move. He didn't know how to explain it. The COVID vaccine had really kind of made him weak. Sometimes he drinks a lot of cranberry juice to try and take the vaccine out of his system and it was frustrating because he hasn't ever been like this. When he had pain like this it reminded him of his torturing and what had happened to him. When the pain came on strong was when it reminded him of that. The medications he was taking were supposed to kill the pain. That was the reason he got so pissed and was trying to ask what was going on. This COVID vaccine is not safe he believed because it has been almost 10 days and it was not helping him. He was still not good. After he got his COVID vaccine on 06Mar2021, he had a little bit of small itching, not much, just a little bit that made him feel not comfortable with it. That was why they kept him for 20 minutes after his vaccine. When he got back home, he was okay, it was nothing serious. But then the day after his COVID vaccine on 07Mar2021, his joints, his muscles and his bones had pain. On 06Mar2021 the itching lasted about 20 minutes. He felt like he was chewing his lip, he was a little uncomfortable and he felt his ribs moving quicker. Nothing happened but he could feel it. He tried to chew his lips a couple of times, but not that much. But after that, he had pain all over on the day after his COVID vaccine, 07Mar2021. By the time this vaccine started getting into his body, it was really hurting and getting worse. He had the shingles vaccine and for 1 1/2 to 2 days, he had pain all over and then 2 days after it was all gone, he was back to normal life. The pain was gone. With this COVID vaccine he thought that maybe it was going to be the same but it was not the same and it was hurting. The shingles vaccine was last year in 2020, 3 months before people knew about the coronavirus that was when he got the vaccine for shingles, so maybe Jan2020 was when he had the shingles vaccine. He had no medical conditions or heart and chest problems. No other vaccine he has taken has ever had this type of side effect to him. He took his shingles vaccine in his right arm and the COVID vaccine was in his left. With both he had the same start of having the bad pain. This COVID vaccine goes deeply to the body. The vaccines job is to wake the body. The vaccine's job is to wake up the body for the virus. The body has to make some kind of soldiers to stand up on the virus and this COVID vaccine had actually made his body weak. After the vaccine is supposed to wake the body, little by little the side effects are supposed to go away. His body was not learning this vaccine. It kept fighting to learn whatever was in this COVID vaccine, his body can't learn it and fight it. That was the reason his body got weak and the pain has not gone away. His body is still in alert and that's why the pain was still there. His body was still fighting. Somehow it didn't match the inside of the body. Maybe for some people that this will happen to, they will be okay but for some they will not be okay. It is not because some people have nothing wrong with them. The patient recovered from itching and discomfort on 06Mar2021; not recovered from any place in his body, his muscles, joints, and bones have had pain previously/ pain in his joints and his bones and it was getting worse/ pain all over on the day after his COVID vaccine; while outcome of other events was unknown. Information about lot/batch number has been requested.
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| 59 | 2021-03-31 | feeling hot |
Occurrence Date: 03/19/2021. Patient c/o feeling hot, and sweaty during the observation around 10:1...
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Occurrence Date: 03/19/2021. Patient c/o feeling hot, and sweaty during the observation around 10:15 after receiving his Covid-19 vaccine. V/S taken, and first reading: BP: 179/103, HR: 100, and Spo2: 96% . Hydration provided. Patient was asked about medications. Patient stated that he had taken his meds @ 06:00. Patient did not remember his baseline. Patient was taken to the ED.
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| 59 | 2021-04-01 | weakness |
Day of shot, 9 hrs later chills, 18 hrs later fever of 103 Day 2, fever 102, chills, fatigue, body a...
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Day of shot, 9 hrs later chills, 18 hrs later fever of 103 Day 2, fever 102, chills, fatigue, body aches Day 3, fever 101.3, chills, fatigue, body aches, rash at injection site, arm pits, feet, headache, unable to sleep, stomach ache Day 4 , no fever, very weak, headache, same rash, can not concentrate, stomach ache
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| 59 | 2021-04-01 | pain in extremity | Headache, nausea, dizziness, sore arm from 2nd shot |
| 59 | 2021-04-02 | unresponsive to stimuli, cold sweat |
PATIENT HAD SYNCOPAL EPISODE, UNAROUSABLE TO STERNAL RUB, PALE, CLAMMY, DIAPHORETIC. VITAL SIGNS OBT...
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PATIENT HAD SYNCOPAL EPISODE, UNAROUSABLE TO STERNAL RUB, PALE, CLAMMY, DIAPHORETIC. VITAL SIGNS OBTAINED. 911 WAS CALLED FOR TRANSPORT.
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| 59 | 2021-04-03 | feeling cold | Muscle soreness throughout the body, fever, chills. The symptoms were gone by 4/3/21 |
| 59 | 2021-04-04 | weakness |
The achiness and pain left me unable to get out of bed for 24 hours. It was, honestly, the worst am...
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The achiness and pain left me unable to get out of bed for 24 hours. It was, honestly, the worst amount of pain I have ever experienced with a vaccine. I got the vaccination around 10:15am and it was around midnight that the full effect hit me. The pain was unbearable for 4-6 hours. Then I was strong enough to get up to go to the bathroom for a Tylenol; it barely made a difference. The nausea is so bad that, as I write, I still can't get myself to overcome the feeling to get something to eat. I'm feeling a bit hungry but the nausea is stronger.
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| 59 | 2021-04-04 | burning sensation |
Extreme fatigue / tiredness, couldn't get up and stay up for 16 hours. Developed hive like rash on 7...
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Extreme fatigue / tiredness, couldn't get up and stay up for 16 hours. Developed hive like rash on 75% of facial skin that was painful / burning sensation for 24 hours and itchy after that. Still have the rash 60 hours after onset of rash, but it has subsided to approximately 50% of facial skin.
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| 59 | 2021-04-04 | pain in extremity |
Inflammation in neck, fever, general malaise, muscle pain, loss of mobility in the left arm that las...
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Inflammation in neck, fever, general malaise, muscle pain, loss of mobility in the left arm that lasts two days. Acetaminophen 500 mg, 2 tabs every 4 hours
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| 59 | 2021-04-05 | weakness |
Fever, Dizziness, Weakness, confusion for 3 day. racing heart and sore throat. Ladder brought patien...
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Fever, Dizziness, Weakness, confusion for 3 day. racing heart and sore throat. Ladder brought patient to Doctor office for treatment. Antibiotics treatment for sore throat to no effect. 2nd dose started and to date same effect. Patient is in pain.
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| 59 | 2021-04-06 | weakness | Very tired and weak |
| 59 | 2021-04-06 | burning sensation |
Blisters (4) and slight swelling / redness on upper lip. Slight irritation and burning pain. Possibl...
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Blisters (4) and slight swelling / redness on upper lip. Slight irritation and burning pain. Possible blister(1) on inside of mouth on lower lip.
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| 59 | 2021-04-06 | muscle twitching |
Muscle twitching in left tricep below injection site. Started 5 days after injection and has persis...
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Muscle twitching in left tricep below injection site. Started 5 days after injection and has persisted for 6 days. Comes and goes 24x7. Not painful. Seems to have subsided today (day6) and preceding night.
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| 59 | 2021-04-07 | weakness, feeling hot, pain in extremity |
He got his vaccine, he felt achy, kind of weak at about 4:00 PM on the day of the vaccine. Later on...
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He got his vaccine, he felt achy, kind of weak at about 4:00 PM on the day of the vaccine. Later on he took his temperature and it was 99 range. It then went up to 101.4 that evening, but he felt very hot. He felt very hot, face was red. Somebody brought him over a thermometer and checked it again and it was 101.7, felt terrible and he took Tylenol. The next day he felt achy like he had the flu, a headache, body aches and weakness, nauseous as well. Then the next morning it was 102.3. It fluctuated throughout the day. Then later it went to 102.7 at 9:00 PM. Then about 2 hours later before he went to bed it came down to 101. Then he woke up on Sunday morning 3/28/21 his temperature was normal, he was exhausted from the fever. He felt run down for a few days after that, knocked out and the nausea came back on 4/3/21. No reaction at the injection site, just standard arm soreness, rash below the area of injection that lasted for about a week and went away. He is still more tired than usual this week, but doesn't know if that's related to the vaccine or not. The right arm 8 days later he got a rash at the injection site and a little bump that felt swollen. That also ended up going away after a day or so.
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| 59 | 2021-04-08 | feeling hot |
Uncontrollable shivering, chills for more than an hour followed by being hot. The whole episode las...
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Uncontrollable shivering, chills for more than an hour followed by being hot. The whole episode last 2-3 hours.
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| 59 | 2021-04-08 | flushing, feeling hot |
Began feeling a little warm and flushed and tired. I felt off overall. On the 8th around 12pm. I cam...
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Began feeling a little warm and flushed and tired. I felt off overall. On the 8th around 12pm. I cam e home from work around 4:30 and laid down til 5:30 and I woke up feeling a little better but around 6:15 I felt the same as earlier that day and then it got worse. My ears were ringing loudly and I had shortness of breath, I had difficulty breathing, and my chest was tight and I had pain in the center of my chest and I was nauseous and hungry but really couldn't eat anything. I checked my BP at home and it was 189/127 and then 192/122. I was well hydrated but I drank 2 16 ounce glasses of water and sat down to try and relax. An hour later the ringing stopped and I was feeling much better. I took my BP again and it was up to 202/126. I decided to go to the ER at this time. around 11pm it was 143/89. Ringing and flushed still present with some stomach issues (4/9)
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| 59 | 2021-04-08 | tingling |
Unusual tingling and sensitivity on skin, of right side of torso (stomach, side and back). Not pain...
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Unusual tingling and sensitivity on skin, of right side of torso (stomach, side and back). Not painful, but sensitive. No rash, or visible difference from skin on left side of torso . Symptoms are mild-not severe.
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| 59 | 2021-04-08 | tremor |
pt says his heart started racing, he was dizzy, had SOB, and hands were shaking. Pt called PCP whic...
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pt says his heart started racing, he was dizzy, had SOB, and hands were shaking. Pt called PCP which told him to get to an ER. He went to ER. They did several test. His heart was miss-firing. They gave him some medication which brought heart rate down but needed to had have an electrical shock. This brought his heart rate down to 85. He has been referred to a Cardiologist which he will schedule appt today.
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| 59 | 2021-04-10 | cold sweat |
Symptoms of mild headache, body ache, fatigue, cold sweat, and nausea and diarrhea began on Saturday...
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Symptoms of mild headache, body ache, fatigue, cold sweat, and nausea and diarrhea began on Saturday afternoon.
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| 59 | 2021-04-10 | feeling hot | dizzy, shakey, hot nausea |
| 59 | 2021-04-10 | flushing |
Patient had the vaccine at 4:03 pm and his 15 minutes was done and the patient left to go to his car...
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Patient had the vaccine at 4:03 pm and his 15 minutes was done and the patient left to go to his car. Patient stated that when he got to his car he felt flush and a little light headed. He decided to make his way back up to the front door because he was not feeling himself. When he got to observation we checked his vitals and his blood pressure was 191/104 and his checks were very red. I repeated the blood pressure again at 4:40 pm and it was 167/92, checked at 4:46 pm BP was 155/103, BP at 4:51 was 175/101, BP at 4:59 was 196/107 and then checked it again but this time on the left arm and the BP was 195/108. Patient was transported By EMS to the hospital for further evaluation.
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| 59 | 2021-04-11 | feeling hot, numbness, tingling |
within 2minutes i felt my feet and toes get hot. whole body. thot it was just a reaction. later that...
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within 2minutes i felt my feet and toes get hot. whole body. thot it was just a reaction. later that day and overnite feet very hot. now its 5days later its so much worse. very numb in whole leg, right foot the most, very tingly-painful, asleep type feeling, But Way Worse. im very scared. hands and fingers, and whole body feels real bad. . feels like dead nerves happening.
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| 59 | 2021-04-12 | sciatica, weakness |
On the 4th day after the injection I start feeling the extreme weakness and extensive heartbeat whic...
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On the 4th day after the injection I start feeling the extreme weakness and extensive heartbeat which forced me to spend a few days in the bed. Right after that, even if the condition in general got improved, I?m still experiencing extensive heartbeat and occasional pain within the heart area. Also, I got new symptoms for the sciatic nerve related pain.
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| 59 | 2021-04-14 | weakness | Joint and muscle aches, low-grade fever, lethargy, loss of appetite, weakness. |
| 59 | 2021-04-15 | pain in extremity |
swollen interphalangeal joints (both hands) with pain; I developed swollen interphalangeal joints (b...
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swollen interphalangeal joints (both hands) with pain; I developed swollen interphalangeal joints (both hands) with pain and resolvable "locking" of my middle fingers; This is a spontaneous report from a contactable Pharmacist (Patient). A 59-Year-old male patient reported for himself that he received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine; Solution for injection; Lot number: EL0140; Expiry date: Unknown) via an unknown route of administration in the left arm on 11Jan2021 at 12:30PM as a single dose for COVID-19 immunization. The patient did not have COVID-19 prior to vaccination. The patients past medical history included Diabetes (Type 2), Hypertension and Hypercholesterolemia. The patient did not have any known allergies. Concomitant medication were not reported. On 18Jan2021, at 07:00 AM seven days after receiving initial COVID-19 vaccine, Patient developed swollen interphalangeal joints (both hands) with pain and resolvable "locking" of my middle fingers. Nine days after second COVID-19 vaccine, the issue resolved. The patient did not receive any treatment. The clinical outcome of developed swollen interphalangeal joints (both hands) with pain and resolvable "locking" of my middle fingers were considered recovered.
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| 59 | 2021-04-15 | cold extremities, unresponsive to stimuli |
Pt has hx of vasovagal reaction when getting any sort of immunization/injection. Pt found in Vaccina...
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Pt has hx of vasovagal reaction when getting any sort of immunization/injection. Pt found in Vaccination boot number 1 with healthcare provider. PT had just received his Pfizer immunization. PT stated he wasn't feeling well and needed a moment. Pt then became diaphoretic, pale, cool skins. Paramedic asked patient if we could take him to cot for observation. PT agreed and stood up turned and sat in wheel chair. PT taken to cot and as we arrived pt became unconscious. Pt was unresponsive to verbal and painful stimuli. Pt remained unconscious for approximately 20 seconds. Once patient regained consciousness he was immediately Alert and Oriented x4, skins were pale, moist, cool. pt was carried to cot during his unconscious episode. pt layed down for a while, vitals were assessed at 1556: BP-128/88, HR 64, RR 22, SPO2- 94%. Pt immediately feeling much better and taken to observation for an additional 30 minutes. Pt advised to let us know if he was feeling faint again.
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| 59 | 2021-04-16 | discomfort |
Within minutes after receiving 2nd dose of Pfizer COVID vaccine (at approximately 1200) patient pres...
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Within minutes after receiving 2nd dose of Pfizer COVID vaccine (at approximately 1200) patient presented to this RN due to complaints of feeling like she would pass out. She was holding her head in a wheelchair and appeared quite uncomfortable. She was safely transported to a recliner to elevate legs. She was lying in a flat position. Mask taken off due to complaints of "having a hard time breathing." Patient complained of LEFT sided chest pain; unable to determine if this pain is acute or chronic. Patients slow to respond and unable to describe symptoms well. Patients slow to respond to questioning. Patient with mildly stuttered speech. Eventually patient admitted to dizziness. Given the nature of presentation, first responder called and arrived quickly. Vitals at 1200: 135/112, semi-Fowler's position, right arm. 84 bpm, apical, regular, 95%, room air. Patient denied swelling, throat tightness. No rash. Patient sat up in chair to help with breathing. Vitals at 1212: Heart rate 101 bpm. No apparent respiratory distress. NP briefly auscultated prior to immediate transport to Emergency Department. Patient transported to Emergency Department via wheelchair with First Responder.
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| 59 | 2021-04-17 | hot flush, feeling cold |
Pfizer-BioNTech Covid 19 Vaccine EUA: One week post-injection I experienced extreme fatigue, body ac...
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Pfizer-BioNTech Covid 19 Vaccine EUA: One week post-injection I experienced extreme fatigue, body aches, chills, shivering, hot and cold flashes. At this time the symptoms have persisted for 30 hours, although the shivering subsided after sleeping through the night. The heavy fatigue and body aches continue however.
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| 59 | 2021-04-17 | numbness, bell's palsy, involuntary muscle movements |
Bell's palsy; eye sight in that eye is getting worse every day; right eyelid was sticking on his eye...
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Bell's palsy; eye sight in that eye is getting worse every day; right eyelid was sticking on his eye and wouldn't shut; he couldn't move his face on the left side and he can't control it at all; blood got really thin and wouldn't clot; left hand got really swollen; entire arm bruised; edema in his hand; edema in his hand got to the point where his skin was cracking; blood got really thin and wouldn't clot; face went numb; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN6207, Expiration Date: Jul2021), via an unspecified route of administration, administered in Arm Right on 11Mar2021 (at the age of 59 years old) as single dose for covid-19 immunisation. Medical history included lupus from 2020 and ongoing, ongoing High Blood Pressure, Spinal Surgeries from 1999, Chronic Pain,Retention water, blood clot issue. The patient previously had tetanus shot. Concomitant medications included losartan potassium; allopurinol; hydroxychloroquine; methocarbamol; morphine sulfate (MS CONTIN); oxycodone; furosemide. Caller states he is calling about the Pfizer Covid 19 Vaccine. Seven days later the dose of vaccine (18Mar2021), patient developed Bell's Palsy which he has never had before and has never had any other problem with. He has seen an ENT, his pain doctor, and his medical doctor and they all say the Covid vaccine has caused the problem he is having. He was told by his ENT this is very possibly permanent. Emergency Doctors are who he went to because he thought he was having a stroke, because half of his face went numb. He has been to the doctor 10 times in the last 7 days, it has not been fun at all. He didn't put it together until he saw the ENT, who said Bell's Palsy is caused from a virus. States he had no idea until he said that, that it could possibly be from the injection. States he has never had Bells Palsy before and it started 8 days after the initial shot. His right eyelid was sticking on his eye and wouldn't shut and he couldn't move his face on the left side and he can't control it at all. Clarifies he couldn't shut his right eye all of the way. Since then they have told him he needs to tape his eye shut for 12 hours a day to keep from going blind. The thing that bothers him is his eye sight in that eye is getting worse every day even though he uses the cream and tapes it shut. His wife told him even with both eyes shut, it will not completely shut because his lower eyelid is hanging down too far. The ENT told him he needs a hearing test today at 2:00p.m. to see if this is going to be a permanent problem. He is getting ready to go to the ear doctor to find out more. At the same time he developed the Bells Palsy, his blood got really thin and wouldn't clot which seems really weird. Also on 18MAR2021, his left hand got really swollen and the entire arm bruised and they said the edema in his hand got to the point where his skin was cracking because his blood got so thin that it couldn't clot at all. He had a blood clot issue in the past. States his arm and hand have improved, he can move his hand again finally. The ENT said that since he has been on Prednisone, for recovery for Bells Palsy, for over a week and gotten worse instead of better, it may be permanent. Prednisone is not working, it has actually gotten worse. Prednisone 10mg for 7 days and to decrease by one tablet every day until gone but states he has gotten worse. Treatments (assessed as for all events): Prednisone. States that it has been two weeks since this happened and the doctor told him the only other option is skull surgery. The bones in his head would be drilled out to make room for the nerves in hopes he would be able to work his mouth again, so not a good thing. Eye cream. He is on disability and his house payment is 3/4 of what he makes, so he can't take care of the medical bills himself otherwise he wouldn't worry about it. It is very depressing. His medical doctor said he hadn't seen any cases of Bell's Palsy for 2 years, and he has seen 4 in the last week so that doesn't give him a lot of confidence even though he is still encouraging people to get the vaccine because it is safer than not.He has multiple visits to the ER 3 times between 18MAR2021 and 19MAR2021 within 24 hours; states he was in the ER for hours and hours but no admission. States they did a CT Scan, MRI, CT with contrast and then after that ended up 22 saw ENT who confirmed the fact that Covid Vaccine that gave Bells Palsy and on 22-23 saw his GM again. Prior Vaccinations (within 4 weeks): None within 4 weeks; states 9 months ago he had a Tetanus Shot. No AE(s) following prior vaccinations. The outcome of the event Bell's palsy, Visual acuity decreased, Eyelid disorder, Orofacial dyskinesia, numbness in face was not recovered; other events was recovering. All events happened on 18Mar2021.
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| 59 | 2021-04-17 | pain in extremity |
Pfizer-BioNTech COVID-19 Vaccine EUA 4/14/21 12:45 pm - vaccination - no issues 11:00 pm - Chills, c...
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Pfizer-BioNTech COVID-19 Vaccine EUA 4/14/21 12:45 pm - vaccination - no issues 11:00 pm - Chills, chattering teeth, nausea 4/15/21 1:00 am - loose bowels, minor headache 8:30 am - Vertigo, unable to stand, collapse on floor, major nausea, dizziness - go straight to bed 8:30 am - 8:30 pm - Sleep off/on entire period, arm pain, drink water, take tylenol, chills, nausea, lethargy 8:30 pm - Midnight - profuse sweating soaking clothes, major headaches, nausea - continue to sleep 4/16/21 Midnight - 6:00 am - Restless sleep, loose bowels at times All day - Awake, tired, occasional nausea. limited appetite 4/17/21 Limited appetite - occasional nausea
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| 59 | 2021-04-18 | bell's palsy | Bells palsy to left side of face |
| 59 | 2021-04-19 | weakness |
Fever (102.6 x 48hrs), Mialgia, Nausua, Diahrrea, severe weakness, dizziness, confusion. Abominal pa...
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Fever (102.6 x 48hrs), Mialgia, Nausua, Diahrrea, severe weakness, dizziness, confusion. Abominal pain & cramps. Left upper arm pain. Symptom course lasted total 5 days and completely resolved by Sunday evening(4/18/21)
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| 59 | 2021-04-19 | weakness |
Patient received vaccination at 10:15am, waited 15 minutes, then went to work. Patient reported blur...
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Patient received vaccination at 10:15am, waited 15 minutes, then went to work. Patient reported blurry vision, cold chills, dizziness and stomach cramping beginning 12:30pm. Patient sat down and began experiencing a new onset headache. Patient tried to get up once, sat down, then tried to get up again and reportedly blacked out. Patient was aroused by coworkers at which time was taken to his residence. Patient did not seek treatment. Roughly 24 hours after the event the patient reported still feeling weak and light headed. Patient was urged to seek medical treatment.
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| 59 | 2021-04-19 | facial paralysis, bell's palsy |
Chief Complaint pt c/o left facial droop starting today, states received 1st dose of Pfizer vaccin...
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Chief Complaint pt c/o left facial droop starting today, states received 1st dose of Pfizer vaccine on 4/16. denies any other symptoms History of Present Illness 59 yo WM here with left facial droop noted by his wife this PM when coming home, wife is a NP. No other symptoms Pt noted that he was recent vaccinated at the megasite Friday, as noted above. Denies: Nausea vomiting headache chest pain SOB falls head trauma changes in vision, double vision falls recent illness new medications change in sleep patterns tinnitus history of: heavy caffeine use heavy alcohol use trauma stroke in the past exposed to meningitis BCP Gen AAOx3NAD PERRLA EOMI, lids intact able to close without issue Neck Supple, no bruits, no JVD appreciated cervical LNno lymphadenopathy CV +s1/s2 RRno RRG PulmCTA bilaterally no RRW Absoft NT/ND no RRGCVA Extremities no edema, radial pulse intact CN 2-12 intact, mm strength UE and LE 5/5, patellar reflex 2/4; no gait disturbance very settle facial droop noted at the left lip, evident at resting and with laughter, not with induced smiling Review of Systems as above Physical Exam Vitals & Measurements Temperature Temporal: 97.5 DEGF Systolic Blood Pressure Cuff: 136 mmHg Diastolic Blood Pressure Cuff: 84 mmHg Peripheral Pulse Rate: 93 BPM Oxygen Saturation: 97 % Respiratory Rate: 16 BR/MIN WT (Kgs): 72.6 kg Weight Calculated (lbs): 160.054 LBS HT (In): 68 INCH as above Assessment/Plan 1 . Left-sided Bell's palsy ( G51.0 ) Grade 2 very mild but has slight noticeable lip paraylsis treat with high dose steroids as rec, eat with it fu in 7 days with PCP supportive care please see the clinical summary (includes immunizations), patient instructions and other supporting documents - as these are supplements to the SOAP note and should be reviewed as apart of the chart. Education provided- verbal, as well as any patient instructions printed. Ordered: predniSONE 20 mg oral tablet, 60 mg 3 TAB, Oral, Daily, X 7 DAYS, # 21 TAB, 0 Refill(s): 172.72, 04/20/21 18:21:00 EDT, Height Calculated (cm), cm, 72.6, 04/20/21 18:21:00 EDT, WT (Kgs), kg
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| 59 | 2021-04-19 | pain in extremity |
Left arm is still sore after 2 weeks of vaccination. The soreness is still the same for the past 10 ...
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Left arm is still sore after 2 weeks of vaccination. The soreness is still the same for the past 10 days, and has not improved. I am not able to lift more than 10 pounds using my left arm with some pain in the forearm or shoulder.
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| 59 | 2021-04-20 | nerve pain | shooting pain of sciatic nerve from hip to thigh and leg. |
| 59 | 2021-04-20 | pain in extremity |
Pain on arm and fever stating later in the same day of taking the shot. It last over a day and fev...
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Pain on arm and fever stating later in the same day of taking the shot. It last over a day and fever reducer was taken.
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| 59 | 2021-04-20 | pain in extremity |
I had minimal reaction to the 1st dose, slightly sore arm at injection site for 3 or 4 days. 2nd dos...
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I had minimal reaction to the 1st dose, slightly sore arm at injection site for 3 or 4 days. 2nd dose, I was feeling off by 3:30pm, mild headache and extremely tired. By 5 I was exhausted, and paranoid about a work situation, paranoia is not part of my normal state of being. By 6pm my left upper arm was very painful from shoulder to elbow. Took aspirin and went to bed at 7pm. Woke at 8am Friday with mild headache an very tired, by 10am was back in bed, slept 4 hours, Repeated the Friday pattern for 2 more days. Monday the extreme tiredness and arm pain abated. Tuesday, the paranoia abated. Now just Brain Fogged.
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| 59 | 2021-04-21 | flushing | Flushing/sweating, shortness of breath. BP 150/83 (pulse 89), 99% O2 sat. |
| 59 | 2021-04-21 | pain in extremity |
pt had right leg swelling and pain starting on 03-22-21 and presented for medical care on 03-29-21 ...
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pt had right leg swelling and pain starting on 03-22-21 and presented for medical care on 03-29-21 was found to have elevated d-Dimers and Doppler RLE showed occlusive clot in right peroneal vein and non-occlusive clot in right popliteal vein
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| 59 | 2021-04-21 | pain in extremity | very sore--neck--back legs |
| 59 | 2021-04-22 | facial paralysis |
Started with an ear ache, went to facility on 3-25-21 to ER Department, continued pain went to ER a...
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Started with an ear ache, went to facility on 3-25-21 to ER Department, continued pain went to ER at Clinic 3/31/21, sores developed on the right side of my head, in my ear and on my tongue. Paralysis on right side of mouth and eye. Lost hearing in right ear, pressure behind right eye and still struggling with severe pain.
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| 59 | 2021-04-22 | speech disorder |
On 7 April, approx 9AM, pt. experienced a TIA (Transient Ischemic Attack or Mini-stroke). Siblings ...
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On 7 April, approx 9AM, pt. experienced a TIA (Transient Ischemic Attack or Mini-stroke). Siblings became aware by 10:30, and by 11:45 he was at the ER. His speech was extremely restricted and he was barely able to speak a few words. Face was partially asymmetric, but gross and fine motor skills basically unaffected. He could walk and write his name, follow commands to move arm and legs. Underwent multiple tests including CAT scan, when no sign of bleed stroke confirmed. At admittance, Stroke Scale score = 4. By 3PM, speech started to return, and continued to return. Continued tests with EEG, EKG, and TTE, but no source for TIA could be pinpointed. Unable to perform MRI due to embedded medical device. By next morning speech had almost returned to normal. No physical restrictions noted on following day. Discharged 6PM on 8 April. Doctors unable to explain cause and could not comment on whether related to receiving vaccine a week prior. Recovery seems to be complete with no negative lasting effects as of 22 April, 2021.
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| 59 | 2021-04-24 | weakness |
Left arm, shoulder, and upper body severe pain. I couldn't lift my left arm. It felt as if I had the...
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Left arm, shoulder, and upper body severe pain. I couldn't lift my left arm. It felt as if I had the flu. Body aches, disorientation, difficulty breathing, severe body weakness, nose running. I used 8hr Tylenol for the pain. I was restless and couldn't sleep Friday and Saturday night. On Sunday, the symptoms began to subside, but the general weakness and disorientation remained.
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| 59 | 2021-04-24 | burning sensation |
Sensation that my brain was on fire or oddly fevered even though my body's temperature did not eliva...
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Sensation that my brain was on fire or oddly fevered even though my body's temperature did not elivate; severe joint pain; very thirsty; This is a spontaneous report from a contactable consumer (patient) via a Pfizer Sponsored Patient Program COVAES. A 59-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 24Mar2021 at 11:30 (Lot number: ER8730) on the left arm as single dose for COVID-19 immunization. Medical history included allergy to cats, asthma from allergy. Concomitant medications were not provided. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 01Mar2021 at 09:30 (Lot number: EN6205) on the left arm as single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient did not diagnose with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. Patient reported that sensation that his brain was on fire or oddle fevered even though his body's temperature did not elevate, not a headache on 24Mar2021 at 22:00. On 24Mar2021 at 22:00, patient also had severe joint pain and very thirsty; lasted about 36 hours. There was no treatment received for the adverse events. The outcome of events was recovered on unspecified date. Information on the lot/batch number has been requested.
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| 59 | 2021-04-24 | pain in extremity, muscle spasms |
Became very ill..Extreme fatigue..Nausea, fever bodyaches leg cramps..Threw up from nausea..Could on...
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Became very ill..Extreme fatigue..Nausea, fever bodyaches leg cramps..Threw up from nausea..Could only lay down..Extreme headache and huge reaction from injection site..Blood sugars would not come down..Remained stubbornly high..Sleep...Wake up..have extreme leg cramps and body aches..Made way to bathroom brvause of nausea..Nearly threw up..Ended up just lying on the floor and going to sleep again...Got up ..Went into bedroom. Sip of diet soda..Back to sleep...Finally got up at 3pm...Signs of being able to come through..Was very close to going to Urgent Care but physically would have been too challenging to go...Had food at 10pm ...Slept through 5am...Soreness in arm has become much less..Signs of survival...Seriously have second thoughts about ever having another vaccine in future unless they improve the process...
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| 59 | 2021-04-24 | pain in extremity |
severe reaction, his muscles in his leg starting aching up. It's felt like all his muscle is moving ...
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severe reaction, his muscles in his leg starting aching up. It's felt like all his muscle is moving on and on. It was very, very painful in the thighs that was going on; brought back pain in his shoulder and in back that he had in the past ; it is very very bad; brought back pain in his shoulder and in back that he had in the past ; it is very very bad; I had to go to ER to give me some kind of shot but pain still there in my leg/painful in the thighs; This is a spontaneous report from a contactable consumer. A 59-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2, via an unspecified route of administration, administered in Arm Right on 26Mar2021 (Lot Number: ER8732) as SINGLE DOSE (at the age of 59 years old) for covid-19 immunisation . Medical history included arthritis from an unknown date and unknown if ongoing, pain from an unknown date and unknown if ongoing. The patient's concomitant medications included oxycodone hydrochloride, paracetamol (PERCOCET) for pain "I am taking pain killer for it but it's not working". Historical vaccination included BNT162B2, dose 1, Lot number: EN6206, on 03Mar2021 for COVID-19 immunization at the age of 59 years old. On unknown date, the patient had severe reaction, his muscles in his leg starting aching up. It's felt like all his muscle is moving on and on. It was very, very painful in the thighs that was going on. He had to go to emergency room (ER) to give him some kind of shot but pain was still there in his leg. It brought back pain in his shoulder and in back that he had in the past and he was weak. "The reason that I stop and it felt pain went away but the back and the leg pain was still there and it is very very bad." Consumer stated, "Yes but I was not sure it was the vaccine causing it I had arthritis and I thought it might have been arthritis is causing it. It was like 10 hours later when I started to experience the side effect." The patient underwent lab tests and procedures which included complete blood count (CBC) : unknown result on unknown date , Comprehensive metabolic panel: unknown result on unknown date. Outcome of the events was unknown. No follow-up attempts are needed. No further information is expected
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| 59 | 2021-04-25 | weakness |
1-5 days swelling and rash, pain in arm at injection side Day 3-4 Throbbing leg - felt artery flutte...
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1-5 days swelling and rash, pain in arm at injection side Day 3-4 Throbbing leg - felt artery flutter. 1-12 days recurring headache 3-18 days pain in shoulder and armpit near injection site Day 12-18 swelling in hand Day 2-18 - extreme fatigue, lack of energy Day 2-18 - higher blood pressure Day 4-18 ? Nausea and forgetfulness
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| 59 | 2021-04-27 | nerve pain |
Shingles on right side head, back, and neck 1 week following second dose. Painful lesions and neurol...
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Shingles on right side head, back, and neck 1 week following second dose. Painful lesions and neurological discomfort as well as muscle pain occured.
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| 59 | 2021-04-28 | pain in extremity |
MUSCLE PAIN THAT STARTED THE DAY AFTER THE SECOND DOSE OF PFIZER COVID VACCINE AND IS PERSISTING AND...
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MUSCLE PAIN THAT STARTED THE DAY AFTER THE SECOND DOSE OF PFIZER COVID VACCINE AND IS PERSISTING AND WORSENING WITH TIME. WE ARE OVER THREE WEEKS OUT AND HIS MUSCLE PAIN SEEMS TO BE SPENDING. THE PAIN STARTED IN THE LEFT SHOULDER AND IS NOW IN BOTH SHOULDERS AND ARMS.
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| 59 | 2021-04-29 | pain in extremity, numbness |
Sore left arm, armpit. Numbness/ache in forearm, slight numbness in hand. bad chills, lot of sweati...
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Sore left arm, armpit. Numbness/ache in forearm, slight numbness in hand. bad chills, lot of sweating starting that evening and continuing. A runny nose, nausea, fever spiked to 103.7 from a normal of ~97.3 at about the 23 hour mark. As of right now 04/30/21 14:21, 3 days later, still a little sweaty, armpit and arm sore, forearm still ache and hand still a little numb.
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| 59 | 2021-04-30 | pain in extremity |
Thumb hurt; Hand swelled up; Elbow was swollen; Intense pain in the elbow; This is a spontaneous rep...
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Thumb hurt; Hand swelled up; Elbow was swollen; Intense pain in the elbow; This is a spontaneous report from a contactable consumer (patient). A 59-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, at age of 59 years old, administered in Arm Left on 09Apr2021 09:45 (Lot Number: EN6200; Expiration Date: 30Jun2021) at single dose for covid-19 immunisation. Medical history included blood pressure increased from 1995 and ongoing (It is controlled), anxiety (young and suffering from anxiety, has no clue why) and family cancer history. The patient previous received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 19Mar2021 09:45 (Lot Number: EN6200; Expiration Date: 30Jun2021), at age of 59 years old, at single dose for covid-19 immunisation. The patient's concomitant medications were not reported. He received the Covid vaccine on 09Apr2021. The following day he later noticed his elbow started bothering him that night, and around midnight it woke him up. He had intense pain in the elbow and tried to tough it out. 4 hours later he was in the ER, it was that bad. When he got there they did an ultrasound and some X-rays. The ultrasound showed his elbow was swollen, and they removed 17cc of fluid. They asked if he had any trauma to his arm and he said absolutely no way. He doesn't know what to think. He was trying to find someone to help with the issue. On a scale of 1 to 10 the pain was a strong 10. To this day it was still bothering him pretty bad. He coundn't work because of it. He could hardly straighten it out because it is so sore. It was painful, but not as bad as Saturday(10Apr2021) and Sunday(11Apr2021) morning. On 13Apr2021, his hand swelled up. That's gone away. His thumb hurt on 14Apr2021 and that had gone away, he just aced that. He put ice on his elbow. His elbow from last night(13Apr2021) to today (14Apr2021) probably had a 30 percent change. It is getting better but it is still sore. He can't straighten it and he is trying to bend it to work it so it doesn't get stiff. With the work he does he needs to use his arms. He works in construction. He got the shot on 09Apr2021, and the pain was later in the day. He received his dose around 0945, and at about 1500 to 1530 he noticed his elbow bothering him. Later that night when he went to bed he was uncomfortable and couldn't sleep. Eventually he did fall asleep and at 0000 he woke up in excruciating pain. He tried to deal with it until 0400 when he went to the ER. His pain is nowhere near what it was. When he tries to straighten it, it is very painful, about a 6. If he bends it back it is much better. If he tries to straighten it the pain level goes up. It is still swelled up a bit. It is hard to say if it has improved, he never really saw it. He went to bed and when he woke up he was in so much pain. He had on his PJs and put on his shoes and left. All he knew was he was in pain. He presumed it was more swollen then, they did the ultrasound and found all that fluid. The pain in his thumb subsided a bit. He took the ice off of it about 30 minutes before this phone call, so about 45 minutes ago. It feels a little better. At least one part of the puzzle is solved. He noticed it at about 0730 this morning. He had an ultrasound on 11Apr2021. He had 3 to 4 X-rays on 11Apr2021. Outcome for events was not recovered. The patient was not diagnosed with COVID-19 prior to vaccination, and Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No follow-up attempts are needed. No further information expected
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| 59 | 2021-05-03 | feeling hot |
For around 5-minute duration: - Stomach knot - Sudden strong sweating in the upper part of my body i...
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For around 5-minute duration: - Stomach knot - Sudden strong sweating in the upper part of my body including my forehead, felt very hot - Dizziness Never experienced such symptoms before in my life
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| 59 | 2021-05-04 | burning sensation, pain in extremity, numbness and pain in extremities |
This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient recei...
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This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8732) at the age of 59-years-old, via an unspecified route of administration in left arm on 22Mar2021 at 15:00 at single dose for COVID-19 immunisation. The patient's medical history was reported as none. He has no known allergies and has COVID prior to vaccination. Concomitant medications included metoprolol, rosuvastatin, oxybutynin, and tamsulosin. There were no other vaccines in four weeks and no additional vaccines administered on the same date of the COVID-19 vaccine. The patient reported that he was having some wild effects from the vaccine and did not know what to do. On 26Mar2021 at 15:00, he was having neuropathy like effects. His hands, arms, legs, and feet were experiencing pain and burning sensations, they were burning like nerve damage; he also has a little burning sensation in his nose and cheeks. He has never had this before. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. He was also having some weird sensations in his calf muscles, these sensations started within the past week and a half (Apr2021) which prompted physician office visit. The physician placed him on gabapentin 100 mg to start from 12Apr2021, but it was not enough, it was titrated up to 300 mg, three times a day and he is scheduled to see specialist soon. The patient mentioned that this vaccine has ruined his health. He also went to an urgent care center because his leg was bothering him, it was swelling on an unspecified date in 2021; he thought he had a blood clot; they did some kind of test where they looked at the leg and did not find anything. He didn't have a particular question. He would just like to talk to someone to see if this was going on with anyone else, if it will go away, or if this was permanent problem he will have. The patient was not tested for COVID post vaccination. He received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0161), via an unspecified route of administration in left arm on 13Apr2021 at 15:00 at single dose for COVID-19 immunisation. The outcome of the events was not recovered.
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| 59 | 2021-05-04 | seizure |
Extreme fatigue; brain fog; Passed out; Told possible seizure; Felt ill shortly after receiving shot...
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Extreme fatigue; brain fog; Passed out; Told possible seizure; Felt ill shortly after receiving shot; Threw up; This is a spontaneous report from a contactable consumer (the patient) and then from a contactable consumer (the patient's wife). A 59-year-old male patient received the first dose of BNT162B2 (lot number not provided), via an unspecified route of administration in the left arm on 31Mar2021 10:00 (at the age of 59-years-old) as a single dose for COVID-19 immunization. The patient had no medical history. The patient did not have any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included: fish oil (OMEGA 3 FISH OIL). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021, the patient felt ill shortly after receiving the shot. Told to sit down. Passed out. Awoke on the floor. Told possible seizure. Sat up. Threw up. Told to lie back down. Ambulance came and took him to the hospital. He spent 90 minutes in the Emergency Room. He was unable to work for a couple of days. He had extreme fatigue and brain fog. He was not back to relatively normal for at least 10 days. Treatment received was reported as yes: ran tests including 3 EKGs, on an unspecified date. The outcome of the events was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19. Information on the lot/batch number has been requested.
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| 59 | 2021-05-13 | weakness |
Headache, feeling sick, weakness, swelling at injection site, pain at injection site, diarrhea, dizz...
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Headache, feeling sick, weakness, swelling at injection site, pain at injection site, diarrhea, dizziness.
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| 59 | 2021-05-13 | burning sensation |
February 7, 2021 to March 20, 2021: Same evening burning sensation in forehead, muscle aches in legs...
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February 7, 2021 to March 20, 2021: Same evening burning sensation in forehead, muscle aches in legs. Following three weeks: sore throat, 3 weeks laryngitis, shortness of breath, chest and upper respiratory pain, overall lethargy, late February and March: 3 weeks abdominal pains and continuous diarrhea .
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| 59 | 2021-05-14 | bell's palsy |
Face was paralyzed/Bells palsy; Tongue felt fat and my lips numb; This is a spontaneous report from ...
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Face was paralyzed/Bells palsy; Tongue felt fat and my lips numb; This is a spontaneous report from a contactable consumer (Patient, self-reported). A 59-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ER8736), dose 1 via an unspecified route of administration, administered in Arm Right on 17Apr2021 10:30AM, as 1ST DOSE, SINGLE for covid-19 immunization. Patient did not have medical history and no known allergy. Concomitant medication's included meloxicam and Multivitamins. Patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with COVID-19, prior vaccination. Patient has not been tested for COVID-19, post vaccination. On 02May2021, (reportedly patient stated that, 8 days after the vaccination), his tongue felt fat, and had lips numb. 2 days later symptoms spread. By Wednesday 05May2021 his face was paralyzed. He went to my physician the next morning and was told he have Bell's palsy. Patient states that, my face may never be normal again. AE resulted in Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. Therapeutic measures were taken as a result of adverse events as prednisone 20 mg twice a day. Outcome of the events was not recovered.
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| 59 | 2021-05-14 | pain in extremity |
Rheumatoid arthritis flare up; Pain in joint involving hand; Injection site papule; Bruising; Sprain...
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Rheumatoid arthritis flare up; Pain in joint involving hand; Injection site papule; Bruising; Sprain; Dizziness; Loss of balance; Sickness; Vision decreased / Bilateral abnormal vision; Blurring of eyes; fatigue; bumps from the injector pen; Pain in extremity / ARM PAIN; This is a solicited report from non-Pfizer sponsored program received from a contactable physician based upon information received by Pfizer from company (21K-163-3820459-00). A 59-year-old adult make received the first dose of intramuscular BNT162b2 (solution for injection; Lot EL3248 expiry information not provided) as a single dose on 12Mar2021 (at 59-years-old) for COVID-19 immunisation. The patient also started to receive subcutaneous adalimumab (HUMIRA, unspecified formulation) 40mg at an unspecified frequency from an unspecified date for arthritis. Relevant medical history included rheumatoid arthritis, inflammation, high blood pressure, red face, red skin, used cane for walking because he could not walk (before adalimumab), and a loss of hearing in the left ear (one month prior to starting adalimumab). It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Concomitant medications included sulfasalazine for inflammation; lisinopril for high blood pressure; and another [unspecified] medication for inflammation. The patient previously received treatment for inflammation with steroids which were not good enough. On an unspecified date in Mar2021, after receiving the vaccine, the patient developed arm pain, it made him tired, he had dizziness, fatigue almost every time, and a loss of balance. The patient had bumps from the injector pen/ Injection site papule, Pain in joint involving hand, bruising, sprain, and sickness. On an unspecified date in Apr2021 the patent experienced bilateral abnormal vision/vision decreased and blurring of eyes. On 09Apr2021, patient received second dose BNT162b2 (solution for injection; Lot EL3302 expiry information not provided) as a single dose. The action taken with adalimumab was unknown. The outcome of the event Sickness was recovered on an unspecified date. The outcome of the events bilateral abnormal vision/vision decreased, blurring of eyes, and fatigue, was not recovered. The outcome of the events pain in extremity / arm pain, bruising, sprain, dizziness, loss of balance, was recovering. The outcome of the events Pain in joint involving hand, Injection site papule, and bumps from the injector pen was unknown. The reporter's assessment of the causal relationship of the event with the suspect product BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts possible. No further information expected.; Sender's Comments: Based on available information, a possible contributory role of subject product, BNT162B2 vaccine cannot be excluded for the reported events of Injection site papule, Pain in joint involving hand, bruising, dizziness, loss of balance, fatigue and sickness, based on temporal relationship. Based on the information provided by the reporter, it appears unlikely that the subject product contributed to the RA flare and other reported events, which likely represent intercurrent medical conditions. There is very limited information provided in this report. This case will be reassessed upon receipt of follow-up information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 59 | 2021-05-16 | nerve pain, pain in extremity, tingling, numbness |
The patient received the Pfizer COVID19 vaccine on 03/30/2021. The patient reports that two (2) week...
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The patient received the Pfizer COVID19 vaccine on 03/30/2021. The patient reports that two (2) weeks after receiving the vaccine he experienced numbness and tingling in both feet. He reports the numbness and tingling progressed up both legs resulting in pain in the knees and thighs. The patient reports having sought medical attention for the progressing symptoms, however, it is unknown what the cause of the adverse reaction. The patient has reported these adverse reactions to me on 05/14/21. The patient reports he currently is still feeling muscle fatigue and nerve pain.
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| 59 | 2021-05-23 | burning sensation |
Three minutes following receiving the vaccination I experienced rapid heart beat, confusion, burning...
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Three minutes following receiving the vaccination I experienced rapid heart beat, confusion, burning in lungs, blood pressure increase. Wheeled down to emergency room. Given anti nausea medication, exrays on heart and lungs, saline IV, heart monitored
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| 59 | 2021-05-24 | numbness | Numbness on left hand Headache Overall body aches Nausea |
| 59 | 2021-05-26 | weakness |
The patient presented to the emergency department with 2 weeks of worsening bilateral lower extremit...
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The patient presented to the emergency department with 2 weeks of worsening bilateral lower extremity pain, erectile dysfunction and urinary retention. 24 hours prior to presentation he had been experiencing new neck pain/headache. He had no chronic history of these symptoms apart from arthritic pain in both knees and hips.
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| 59 | 2021-05-26 | muscle twitching | twitching nerves (including but not limited to left arm) tinnitus |
| 59 | 2021-05-26 | pain in extremity |
night of 5/18 into early morning of 5/19: Pain in right arm, and upper right back, shoulder, and che...
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night of 5/18 into early morning of 5/19: Pain in right arm, and upper right back, shoulder, and chest. Ultimately Vomiting violently. Could not lie down without the pain returning. 5/19 Day: Had light breakfast and dinner. No vomiting, but could not lie down without same pain. Morning of 5/20: Breakfast of cereal and fruit at 9am. And noon, I experienced pain again, vomiting at noon. Then to Urgent care, then, Emergency Room, then Hospital.
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| 59 | 2021-05-26 | pain in extremity |
the patient reported that he took Tylenol for the pain in his arm but that it is still hurting into...
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the patient reported that he took Tylenol for the pain in his arm but that it is still hurting into his shoulder and down his arm 21 days after receiving the immunization
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| 59 | 2021-05-28 | weakness |
s/p 2 doses of Covid-19 vaccine. Pt presented for weakness, SOB, fatigue progressive over the past ...
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s/p 2 doses of Covid-19 vaccine. Pt presented for weakness, SOB, fatigue progressive over the past month prior to admission. Found to be pancytopenic with bone marrow biopsy consistent with MDS. He was started on chemo but stay was complicated by neutropenic fevers, epistaxis, retinal hemorrhage, AKI, fluid overload, hypoxic respiratory failure, atrial fibrillation with RVR, and shock. He ultimately had a heart attack while admitted and was transitioned to comfort care after medical interventions could not stabilize hemodynamics.
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| 59 | 2021-06-01 | face paralysis, seizure |
I63.9 - CVA (cerebral vascular accident) I63.9 - Acute ischemic stroke R29.810 - Facial weakness R...
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I63.9 - CVA (cerebral vascular accident) I63.9 - Acute ischemic stroke R29.810 - Facial weakness R56.9 - Unspecified convulsions
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| 59 | 2021-06-02 | nerve pain |
Pain neck; Nerve problem in my neck as a result of getting the first COVID-19 Vaccination shot; Nerv...
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Pain neck; Nerve problem in my neck as a result of getting the first COVID-19 Vaccination shot; Nerve in my neck is causing the problem; They have called pinched nerve; I also had that shot and It's inspires a little nerve problem in my neck.; This is a spontaneous report from a contactable consumer or other non hcp(patient himself). A 59-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8727; Expiration Date: 31Jul2021) via an unspecified route of administration, administered in left arm on 21Mar2021(not clarified further) as 1ST DOSE, SINGLE for COVID-19 immunization. The patient previously received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT number ER8729, Expiration date: 31Jul2021) in right arm on 11Apr2021 for COVID-19 immunization. The patient's medical history. On 27May2021, it was reported that he was prescribed Gabapentin, 400mg, by mouth 3 times a day .Three days after having the shot, he started having pain in the neck, so upon then he went to his primary care physician, scheduled an MRI as suggested, to see where the pain or what was causing the pain came from and it comes back out, he had a nerve problem in his neck as a result of getting the first COVID-19 Vaccination shot. On 27May2021, it was reported he had little problem in his neck on unspecified date and was called as pinched nerve. He wanted to know if he is the only one experiencing this nerve problem from getting the COVID-19 Vaccination shot. On 27May2021, it was reported that Because when I received this shot after complaint the pain in the neck 2 days after he received the shot and it has not, one away today(27May2021) so as if today(27May2021) when It happened he (word not clear) Primary care to suggest me have a MRI and it administered a little problem in my neck. Reporter seriousness for I also had that shot and Its inspires a little nerve problem in my neck and this is little problem in my neck, They have called pinched nerve: Unspecified. Investigation Assessment: Yes. The patient underwent lab tests and procedures which included magnetic resonance imaging on 05May2021: unknown. The outcome of pain neck , nerve problem in neck as a result of getting the first covid-19 vaccination shot; nerve in my neck is causing the problem, they have called pinched nerve, also had that shot and it's inspires a little nerve problem in my neck was unknown. Follow-up (27May2021): New information received from contactable consumer(patient himself) which included: Concomitant medication, Investigation and Date of Vaccine: It was the 3rd March, the 03Mar2021, 21 day of the 3rd March 2021 of this year (date is not further clarify, Hence not captured in tab). No follow-up attempts are needed. No further information is expected.
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| 59 | 2021-06-02 | pain in extremity |
Received vaccine on 3/26/21 by 3/27/21 in the afternoon, arm became real sore. On 3/28/21 started ...
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Received vaccine on 3/26/21 by 3/27/21 in the afternoon, arm became real sore. On 3/28/21 started running a 102 temp with body aches, by 3/29/21 whole arm was sore and that night moved into the chest area. In the middle of the night pain was unbearable and took him to hospital where we were told he was having a heart attack. Transferred him by ambulance to Regional hospital.
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| 59 | 2021-06-08 | feeling hot, electric shock sensation |
Starting on the day of the vaccine (2nd dose)- I felt "a warm, chemical and electrical sensation" in...
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Starting on the day of the vaccine (2nd dose)- I felt "a warm, chemical and electrical sensation" in my chest a few hours after the vaccine. The next morning, I was unable to have a bowel movement, when usually I am very regular. I was not able to have a bowel movement for a couple of days. I felt very constipated and would try to force myself to have a bowel movement. I ate more fiber and fiber pills and drink more water, which was uneffective. I was finally able to have a bowel movement but it took a lot of force and would push the point of exhaustion and almost passing out. On 2/19/2021, I decided to seek medical care for my constipation, stomach cramps, fatigue, difficulty concentrating and shortness of breath. The doctor diagnosed me with Covid long hauler (I had a previous covid infection in 11/2020). I was prescribe probotics (for constipation) and rest for 2 months. I am still feeling fatigue and having heart palpitations. They order ECG(normal) and blood work (normal).
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| 59 | 2021-06-09 | migraine |
blood pressure was elevated; a migraine like headache; persistent severe headache; This is a spontan...
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blood pressure was elevated; a migraine like headache; persistent severe headache; This is a spontaneous report from a contactable consumer (patient's wife). A 58-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 20Apr2021 (Lot number and Expiry date was not reported) as 2nd dose, single dose for COVID-19 immunisation. Medical history included ongoing body mass index increased. The patient's concomitant medications were not reported. The patient received first dose of vaccine on an unspecified date for COVID-19 immunisation. History included he does not really take anything. He has had some injuries lately but that is not a medical condition. On 20Apr2021 the patient experienced a migraine like headache, on an unspecified date the patient experienced blood pressure was elevated. He has had a persistent severe headache which sometimes feels like a migraine since receiving the vaccine. She was concerned because his MD has never heard of a headache lasting this long (approximately 3 weeks) after the vaccine. She wants to know if this has been reported before. The migraine like headache from what caller's husband said was it started in the evening. He had the vaccine in the morning, but caller was a little fuzzy on that because they did not go together. By evening, he had a dull headache that got worse. He has headache ever since. He went to the doctors a week ago and they checked his blood pressure and did all kinds of things. They did say they thought there was a chance it was the vaccine even thought they had not heard of it lasting that long. This week, yesterday, they took him to the ER to get an evaluation and it just will not stop. The family doctor did full blood workup and everything was in normal ranges. They took his sugar and protein that tells you hydration. His blood pressure was elevated. When he went to the ER, caller things they repeated the screenings. They did carbon monoxide testing, CAT Scan, and Chest x-ray. Everything came out good or, well, it was negative. They want him to see a neurologist. They hooked him up to an IV and they tried to relieve the pain with a headache cocktail and it did not take the edge off of it. So, they are a little baffled by that. Caller does not know specific dates, times, or results. Caller states she does not know what the medications were, maybe it was Toradol was one thing she heard, and they also gave him Benadryl with it. They said it was something they give to people with migraines and it takes it out and helps them sleep. He usually does not take anything but she got him to try allergy medicine, a couple days of Excedrin, and a couple of days of other things. None of them seem to work. He told the ER and they said if it does not work, do not take it. Also, he took Aleve a couple of days. Caller does not have any of this information as she is at work, and she states she did buy all of them. He tried name brand Aleve, Allegra for about 3 days, generic Excedrin which she thinks was Ibuprofen, and Tylenol. Caller confirms her husband was not admitted to the hospital, they sent him home with a referral to follow up with neuro and not the family doctor, and to come back if it gets worse. Today he was supposed to call them. Caller's husband was at the ER yesterday, 09May2021. A CAT Scan showed no mass or anything. They gave him several different things to relieve the headache and nothing worked. The outcome of the events was unknown. Information on the lot/batch number has been requested.
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| 59 | 2021-06-09 | muscle twitching | TWITCHING OF NERVE BELOW OUTER CORNER OF LEFT EYE |
| 59 | 2021-06-09 | tingling, numbness and pain in extremities |
Left ulnar neuropathy. Tingling in fingers and fatigue in arm. Soreness at injection site. Has no...
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Left ulnar neuropathy. Tingling in fingers and fatigue in arm. Soreness at injection site. Has not subsided.
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| 59 | 2021-06-09 | tingling, tremor, seizure |
about 2 weeks after 2nd injection, have had 3 episodes of left arm and hand (stroke affected), tingl...
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about 2 weeks after 2nd injection, have had 3 episodes of left arm and hand (stroke affected), tingling, then hand seemed to shake progressing to arm violently shaking for a few minutes, conscious each time, but seemed like a dream, wet the bed unknowingly until waking up and feeling nauseous. The third time 05/30/2021, went by ambulance to emergency room and told they were seizures. was prescribed Levetiracetam 500mg. No seizures so far. Followed up today 06/10/2021 with primary care physician. Have July 21,2021 follow up appointment with neurologist *The reason I am reporting is because of my primary care physicians response to a comment I made to him about my sister thinking it could be the covid vaccine, while I thought perhaps it might be mini strokes, and he said it wasn't known that it might not be the vaccine. They told me in the hospital that the mri didn't show any more stroke damage than what had occurred from the initial stroke I had earlier.
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